Search results from the Australian New Zealand Clinical Trials Registry

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Feasibility of a community engagement program for developing improved hand hygiene practices to reduce healthcare associated infections in hospitals.

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Trial Information

Trial summary

The overall objective of this study is to pilot test the feasibility of a community and consumer engagement strategy using design thinking and EBCD methodologies in the healthcare setting. This study aims to invite consumers, carers, healthcare workers and/or visitors to the hospital to attend collaborative workshops and/or the InstaBooth (an interactive booth) to share their experiences and suggestions for improving hand hygiene practices and/or reducing hospital-acquired infections and inform the design of possible solutions to these healthcare problems. After data analysis is completed, one of the possible solutions designed in the collaborative workshops will be implemented at the study site and its impact will be evaluated.

Broad Health Conditionhand hygiene practices of healthcare workers
healthcare-associated infections

Specific Health ConditionInfection
Studies of infection and infectious agents
Public Health
Health promotion/education
Public Health
Health service research

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Royal Brisbane & Womens Hospital - Herston

Postcode
4029 - Herston

Anticipated date of last participant enrolment31/10/2017

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Consumers and/or carers were invited via the Metro North Hospital & Healthcare Service Consumer Registry to participate in the collaborative workshops for this study. There are no set inclusion criteria to participate in the collaborative workshops, however it is desirable to engage consumers and/or carers who had experienced healthcare-associated infection/s, observed poor hand hygiene practices or were interested in developing possible solutions to these healthcare solutions. Healthcare workers who were employed by Cancer Care Services at the study site were invited to participate in the collaborative workshops.

There are no set inclusion criteria to participate in the InstaBooth during its two-week installation. It is an interactive booth open to the public.

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

Adults who are 18 years or older will be invited to provide written consent to participate in the collaborative workshops. People of all ages are invited to participate in the InstaBooth during its two-week installation.
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Nicole Gavin
Primary Sponsor Address: Cancer Care Services Royal Brisbane and Women's Hospital Building 34, Level 2 Butterfield St Herston QLD 4029
Primary Sponsor Country: Australia

Trial IDACTRN12617001135303

UTNNil known.

Contact person for information and recruitmentMs
Nicole Gavin
Cancer Care Services Royal Brisbane and Women's Hospital Building 34, Level 2 Butterfield St Herston QLD 4029
+61 7 3646 5833

Further information iconnicole.gavin@health.qld.gov.au
Australia

Using cognitive interviews with parents to improve the design of short food questions measuring young children’s food intake

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Trial Information

Trial summary

Childhood obesity is a global health problem, affecting one in five Australian children by age five. Given the persistence of obesity from childhood into adulthood, it is essential to establish healthy eating habits from a young age. Monitoring obesity trends, evaluating scaled-up obesity intervention programs and making informed policy and practice decisions depends on the availability of suitable assessment tools. However, research and evaluation in this area is limited by the lack of validated and ‘fit-for-purpose’ tools for measuring food intake of young children. Short food questionnaires have the capacity for rapid reporting of food intake, are quick to administer in a variety of formats and have low respondent burden, making them an appealing and viable approach to monitor population dietary intake and evaluate intervention programs. However, a recent review of short questions assessing child food intake found that no single set of short questions provided reliable and valid estimates of intake across a range of food groups. 

Better understanding of the thought processes and recall strategies used by parents when responding to questions about their children’s food intake can improve the validity and reliability of short food questions. Cognitive interviewing approaches are used to study the way people understand, mentally process and respond to questionnaires, and can therefore provide novel insights for improving short food questions. The aim of this study is to use cognitive interviewing to improve understanding of how parents of 3-7 year old children report what, how often and how much their children eat to improve the measurement accuracy and acceptability of questionnaires measuring young children’s food intake. A secondary aim is to understand why certain food groups perform worse than others in measuring children’s food intake. This study will use semi-structured cognitive interviews, combining think-aloud and retrospective probing question approaches to evaluate question comprehension and recall strategies used by parents when reporting their children’s intake of discretionary foods, cereals and grains, meat and proteins and vegetables. Interviews will be audio-recorded, transcribed verbatim, and analysed for themes related to understanding and interpretation of short food questions and recall strategies used. The findings of this study will used to improve the design of short questions measuring young children’s food intake. 

Broad Health ConditionDietary intake
Childhood obesity

Specific Health ConditionDiet and Nutrition
Obesity

Recruitment statusRecruiting

Recruitment Details
Recruitment State
SA

Anticipated date of last participant enrolment30/11/2017

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

- Parents or primary caregiver (responsible for child feeding) with one or more children aged 3-7 years. 
- Parents of vegetarians/vegans will be included, and will not be asked questions about meat intake. 
- Sufficient English fluency to undertake an interview. 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

Parents of children with conditions which effect their eating will be excluded. For example food intolerances or allergies, Coeliac Disease, Type 1 Diabetes, Cystic Fibrosis.
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Dr Dorota Zarnowiecki
Primary Sponsor Address: School of Pharmacy and Medical Sciences, University of South Australia, City East Campus, Frome Road, Adelaide, SA, 5000. Postal address: GPO Box 2471, Adelaide, SA, 5001
Primary Sponsor Country: Australia

Trial IDACTRN12617001091392

Contact person for information and recruitmentDr
Dorota Zarnowiecki
School of Pharmacy and Medical Science University of South Australia GPO Box 2471 Adelaide SA 5001
+61 8 8302 2501

Further information icondorota.zarnowiecki@unisa.edu.au
Australia

TrueNTH solutions: an integrated multi-component intervention to improve the lives of men with prostate cancer in Australia

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Trial Information

Trial summary

The Movember Foundation and Beyondblue have established the TrueNTH program to develop and implement an integrated multi-component care model to improve the lives of men with prostate cancer and their partner/carer in a variety of health care settings in Australia. The primary aim of this study is to implement and evaluate the impact of the program on men's health outcomes and quality of life.

Who is it for?
You may be eligible to participate in this study if you are over 18 years and have been diagnosed with prostate cancer and are receiving services from any of the participating sites. You may also nominate one partner/carer or support person, who will also be invited to participate if they are over 18 years and competent to give informed consent and complete questionnaires.

Study details
The study involves implementation of the following components of care to men with prostate cancer according to their stage of disease and individual needs: (1) care coordination, including screening, assessment, information provision and education, ongoing monitoring, navigation and referral,  and practical and social support; (2) decision support; (3) lifestyle management, including individual exercise program and nutritional advice; (4) specialised clinical support services, including psycho-social support and management, sexual health support, continence management and other specialised clinical support; (5) prostate cancer comorbidities management; and (6) partner/carer support. 

While each component of the intervention is available for all participants, the intervention and each of its components are tailored to men’s stage of disease and their health related needs. Delivery of specialized support services will depend on resource availability, access, treating specialist /team preference and preference of the man.

Men in this study will be asked to complete up to 5 surveys over a 12 month period in order to assess their prostate health symptoms, quality of life and mental health. Health service and carer-related outcomes will also be measured. At 6 months after the participation, men and/or their partner/carer may be asked to participate in individual interviews. 

Findings of the study will enhance our understanding of outcomes and areas for improvement, which in turn will benefit men with prostate cancer and their partner/carer.

Broad Health ConditionProstate cancer

Specific Health ConditionCancer
Prostate
Public Health
Health service research

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NT,QLD,SA,TAS,VIC

Hospital
Austin Health - Austin Hospital - Heidelberg

Hospital
Barwon Health - Geelong Hospital campus - Geelong

Hospital
Alice Springs Hospital - Alice Springs

Hospital
Tennant Creek Hospital - Tennant Creek

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
The Canberra Hospital - Garran

Hospital
Royal Hobart Hospital - Hobart

Hospital
Mater Adult Hospital - South Brisbane

Postcode
3084 - Heidelberg

Postcode
3220 - Geelong

Postcode
0870 - Alice Springs

Postcode
0860 - Tennant Creek

Postcode
4102 - Woolloongabba

Postcode
2605 - Garran

Postcode
7000 - Hobart

Postcode
4101 - South Brisbane

Anticipated date of first participant enrolment6/02/2017

Anticipated date of last participant enrolment31/12/2017

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Men will be eligible for the study if they have been diagnosed with prostate cancer and are receiving services from any of the participating sites. His partner/carer must be aged 18+ years; competent to give informed consent; and able to complete questionnaires.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

Men will be excluded from the study if they are:
* too unwell (as determined by treating clinician); and/or 
* have difficulties in adequately understanding written or verbal information in English; and/or 
* have physical, psychological or cognitive difficulties that would prevent them from participating in the study or completing self-reported outcome measures.
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Professor Patsy Yates
Primary Sponsor Address: School of Nursing Queensland University of Technology Victoria Park Rd Kelvin Grove Queensland 4059
Primary Sponsor Country: Australia

Trial websitewww.truenth.org.au

Trial IDACTRN12617000174381

Contact person for information and recruitmentProf
Patsy Yates
School of Nursing Queensland University of Technology Victoria Park Rd Kelvin Grove Queensland 4059
+61 7 31383835

Further information iconp.yates@qut.edu.au
Australia

Listening to preferred music to reduce risky wandering: A feasibility study

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Trial Information

Trial summary

In the absence of effective alternatives, residential aged care (RAC) still resort to using pharmacological interventions, such as antipsychotic and sedating medications, to manage behaviours of dementia despite there being strong evidence that these are ineffective and are associated with severe adverse outcomes for the person with dementia. Non-pharmacological interventions are recommended as best practice to mitigate adverse outcomes associated with behaviours of dementia. There is considerable evidence that listening to preferred music reduces agitation in dementia. However, there is also robust evidence that dementia-related wandering and agitation are distinct phenomenon. Therefore we cannot assume that an intervention effective in reducing agitation will also reduce aspects of wandering that incur risk or result in negative outcomes for the person with dementia. There have been no known trials of music based interventions for people with dementia who wander, despite the pressing need for non-pharmacological interventions in this area. The goal of this applied research is to test the feasibility of using an intervention protocol, previously found to be effective in reducing agitation for people with dementia, to determine if it can be used with people who wander.
Therefore the aims of this feasibility study are:
1) For people with dementia who wander and exhibit boundary transgression (BT) (entry into out of bounds and hazardous areas) in residential aged care (RAC):
a. Is listening to music for a period of 20 minutes five times per week for 3 weeks tolerated?
b. Is listening to the music via ear bud head phones tolerated?
c. Do participants enjoy listening to the music?
2) Does listening to preferred music daily for 20 minutes under two conditions:
a) Reduce risky aspects of wandering including frequent ambulation and boundary transgression (BT)?
b) Reduce participant agitation?
c) Provide immediate pleasure to the participant?
3) Are facility care staff able to reliably identify residents with dementia who wander and exhibit BT at an intensity that is observable?
4) Do care staff and family members perceive the music intervention to be beneficial for resident with dementia who wander?

This feasibility study will use cluster randomisation (Facility 1 and Facility 2) to trial two intervention conditions:
Condition 1: Daily (Mon-Fri) session of listening to preferred music for 20 minutes, 30 minutes before unique peak activity period 
Condition 2: Daily (Mon-Fri) session of listening to preferred music for 20 minutes at a randomly selected time between 10 am-7pm not including 30 mins prior to individual peak activity periods.
Pre, during and post intervention measures of wandering characterisitics (frequency, boundary transgression, pattern), mood and agitation will be collected.

Broad Health ConditionDementia
Wandering

Specific Health ConditionNeurological
Dementias
Neurological
Alzheimer's disease

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Postcode
4022 - Rothwell

Anticipated date of last participant enrolment28/02/2017

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

> 55 years
Severe dementia as documented in medical history and confirmed with Global Deterioration Scale
Positive history of wandering as reported by care staff and confirmed using Revised Algase Wandering Scale
Independently ambulant (wheelie walker and walking stick acceptable
Not  experiencing an acute mental illness
Able to listen to music
Enjoys listening to music
Walks > 5000 step per day

Minimum age55 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Not severe dementia
Not independently ambulant
Does not walk > 5000 steps per day
Experiencing an acute psychotic episode
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Queensland University of Technology
Primary Sponsor Address: Victoria Park Rd Kelvin Grove, Qld 4059
Primary Sponsor Country: Australia

Trial IDACTRN12617000088347

UTNU1111-1189-5507

Contact person for information and recruitmentDr
Margaret MacAndrew
QUT Victoria Park Rd Level 3 N Block Kelvin Grove, Qld 4059
+61 7 31385956

Further information iconmargaret.macandrew@qut.edu.au
Australia

Experience of a diagnosis of advanced melanoma: The perspective of bereaved family carers

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Trial Information

Trial summary

The primary purpose of this study is to identify supportive and palliative care needs  from the perspective of bereaved family carers of deceased advanced melanoma patients from diagnosis of advanced disease to death.

Who is it for?
You may be eligible to participate in this study if you are aged 18 or over, are English-speaking and were the main carer of a person who died 2 to 18 months previously as a result of melanoma.

Study details
All participants in this study will complete a single 30-90 minute interview about supportive care needs from diagnosis to death of a family member with advanced melanoma. It is hoped that from these interviews, researchers will identify the supportive care needs of these individuals. 

Broad Health ConditionAdvanced melanoma

Specific Health ConditionCancer
Malignant melanoma

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,VIC

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
The Poche Centre, Melanoma Institute Australia - North Sydney

Postcode
4102 - Woolloongabba

Postcode
3000 - Melbourne

Postcode
2060 - North Sydney

Anticipated date of last participant enrolment28/02/2017

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Being a bereaved family carer who provided the majority of care for a person who died 2 to 18 months previously as a result of melanoma; being a bereaved family carer of person who received treatment at Peter MacCallum Cancer Centre, Melanoma Institute of Australia or Princess Alexandra Hospital; and being 18 years or older and English speaking.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

Bereaved carers who indicate they do not wish to participate.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Queensland University of Technology
Primary Sponsor Address: 60 Musk Avenue Kelvin Grove Qld 4059
Primary Sponsor Country: Australia

Trial IDACTRN12616001667404

Contact person for information and recruitmentDr
Jenny Fox
Queensland University of Technology 60 Musk Avenue Kelvin Grove Qld 4059
+61 7 31380136

Further information iconjennifer.fox@qut.edu.au
Australia

Effect of attention bias modification (ABM) on chronic pain and associated health outcomes in Defence personnel

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Trial Information

Trial summary

Pain confers a survival advantage by drawing our attention to injury. Yet this attention bias towards pain-related cues can become maladaptive in people with chronic pain. Importantly, the direction of attention can be modified using a method known as attention bias modification (ABM). Preliminary research suggests this approach may be effective for the treatment of chronic pain. This is the first study to examine its effectiveness in a military population.
This study aims to determine whether multiple sessions of an ABM using pain cues will reduce attention bias to pain cues, reduce pain severity and related disability (e.g., pain interference) and improve mental health in ADF members with chronic pain. The study will be a parallel-groups randomized superiority trial comparing 5 sessions of ABM (using pain-related word cue attention modification training via a modified dot-probe task) versus sham training (i.e., placebo control condition, via a dot-probe task) in 100 Defence personnel who self-report chronic pain experience lasting at least 3 months. 

100 Australian Defence Force members who report chronic pain (persisting at least 3 months) will be recruited and randomly allocated to undergo either ABM training or sham training (placebo control comparison). Pre- and post-intervention attention biases will be assessed via a computerised task (<10 mins) where reaction times for different categories of pain words will be measured. At each of the five training sessions, participants in the intervention group will undergo a modified version of this computerised task (< 10 mins) which implicitly trains participants to direct their attention away from these target cues. Control group participants will complete an equivalent task without the training contingencies. Questionnaires assessing demographic and key outcome variables will be completed via an online survey prior to the first training session (baseline) and at 1-month follow-up. During the 5-week intervention period, a brief (5-10 mins) online survey will be completed the next day following each training session to assess incremental changes in mood and pain ratings.

Broad Health ConditionChronic pain

Specific Health ConditionMental Health
Other mental health disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Anticipated date of first participant enrolment24/10/2016

Anticipated date of last participant enrolment31/01/2018

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Aged 18 years or older,
currently serving or ex-serving Defence member,
have been experiencing pain for at least 3 months, and
had this pain experience in the last few months

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

No exclusion criteria. Participants are only required to meet the inclusion criteria.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Queensland University of Technology (QUT)
Primary Sponsor Address: Queensland University of Technology Kelvin Grove campus Victoria Park Road, Kelvin Grove QLD 4059
Primary Sponsor Country: Australia

Trial IDACTRN12616001460493

UTNU1111-1186-7215

Contact person for information and recruitmentDr
Melanie White
Queensland University of Technology Kelvin Grove Campus Victoria Park Road Kelvin Grove, QLD, 4059
+61 7 3138 4714
+61 7 3138 0486
Further information iconmelanie.white@qut.edu.au
Australia

Efficacy of nasogastric and endotracheal tube securement devices, preventative dressings and topical skin applications for reducing device-related pressure injuries in intensive care patients; a pilot study

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Trial Information

Trial summary

Patients in the intensive care unit (ICU) are known to be at higher risk of developing pressure injuries than other patient populations due to their illnesses and the types of therapies (medications, devices and technologies) used to treat their life-threatening event. More medical devices are used in critically ill patients because of the life-saving treatments needed and, thus, there are often high rates of medical device-related pressure injuries.  Medical device-related pressure injuries are suspected when an injury has the same shape or outline as the device. Stomach tubes for feeding patients, and breathing tubes for mechanically assisted breathing, are the two most common devices used in ICUs. Together they cause the most medical device-related pressure injuries in the intensive care. Critically ill patients in the ICU with medical devices are nearly four times more likely to develop a pressure injury of any kind. There has been some research into ways to reduce medical device-related pressure injuries but none of these suggested methods have been tested in large patient groups.  Hence, the aim of this project is to test the effectiveness of different ways of securing these devices, the use of a thin dressing under the device, regular assessment of your skin beneath the device, and regular repositioning of the device. The combination of these preventative methods in an intensive care environment has not been tested.  
This study will examine whether ICU patients with NGT or ETT who receive the intervention demonstrate less medical device related PI compared with patients who receive standard care practices.

Broad Health ConditionCritical illness
Pressure injuries

Specific Health ConditionSkin
Other skin conditions

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Royal Brisbane & Womens Hospital - Herston

Postcode
4029 - Herston

Anticipated date of first participant enrolment27/02/2017

Anticipated date of last participant enrolment31/12/2017

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

All ICU patients = or >18 years who have a NGT and/or ETT in situ
Patients who are expected to remain in ICU > 24 hours 
NGT or ETT inserted a maximum of 12 hours prior to ICU admission
Patients readmitted to ICU with no oral or nasal skin injury present
NGT arm only - must have wide bore NGT and an ETT in situ.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Burn patients with an ETT wired in place (ETT arm only)
Patients with NGT sutured in place or nasal bridle (NGT arm only)
Patients with facial trauma
Traumatic brain injured patients requiring intracranial pressure monitoring and/or ventricular drainage of cerebrospinal fluid
Cervical spine injured patients who have a hard collar in situ
Hirsute patients with beards where patient permission to shave is not possible
Patients who are receiving non-invasive ventilation
Patients with a device (NGT or ETT) predicted to be in situ < 48 hours.
Patients with a community or hospital-acquired NGT or ETT PI diagnosed within 24 hours of admission to the ICU.
Patients on whom treatment is withdrawn or who are being palliated.
Patients currently enrolled on three studies in the ICU.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Queensland University of Technology
Primary Sponsor Address: GPO Box 2434; Brisbane, QLD 4001.
Primary Sponsor Country: Australia

Trial websiteNil

Trial IDACTRN12616001174471

UTNU1111-1186-2392

Contact person for information and recruitmentProf
Fiona Coyer
School of Nursing, Queensland University of Technology and the Intensive Care Services Department, Royal Brisbane & Women's Hospital. Level 2, Centre for Clinical Nursing, Royal Brisbane and Women’s Hospital, Butterfield St., Herston, QLD 4029.
+61 7 3646 2140

Further information iconf.coyer@qut.edu.au
Australia

Nutrition and Lifestyle Modifications to an Internet-based Treatment for Alcohol Misuse

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Trial Information

Trial summary

The current project aims to assess the impact of a combined treatment, comprising an existing online alcohol support program – OnTrack (www.ontrack.org.au), together with emails and newsletters focusing on nutrition and healthy lifestyle "OnTrack to Cutting Down and Feeling Good" emailed newsletters.

Approximately150 male and female participants, aged over 18 years and drinking more than 14 standard drinks per week will be recruited in to the OnTrack online alcohol program. They will be randomised into three groups and assessed on their drinking behaviour, physical activity, and diet at the start of the study and then again after participating in OnTrack Alcohol and receiving the emailed "OnTrack to Cutting Down and Feeling Good" newsletters. 

Broad Health ConditionAlcohol Misuse

Specific Health ConditionPublic Health
Other public health
Diet and Nutrition
Other diet and nutrition disorders
Mental Health
Addiction

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Postcode
4059 - Kelvin Grove

Anticipated date of last participant enrolment28/02/2017

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Participants must report a weekly alcohol consumption over the previous month of >14 standard drinks/week for both men and women.

Participants must have sufficient English to complete treatment and assessments without translation and be able and willing to access the internet and email or text messages.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Use of injected drugs in the previous month or report daily use of an illicit substance. Self-reported history of a psychosis lasting > 2 days or a diagnosis of Bipolar Disorder. Acutely suicidal.

People under the age of 18 have been excluded from this research as child and adolescent treatment requires different clinical considerations and approaches than adult. 



People in existing dependent or unequal relationships with any member of the research team will not be recruited into the study to avoid any potential coercion or breaches of confidentiality. Any people in such relationships who express interest in the research will be referred to other appropriate sources for treatment. 

As is the case for adolescents, it is recommended by the NHMRC that pregnant women abstain from alcohol use for the duration of their pregnancy. As this project does not specifically promote or require abstinence as a treatment goal, this treatment could directly conflict with this advice. Additionally, the risks involved in treatment failure are too high to be acceptable. Any pregnant women referred to the project will be referred for appropriate face-to-face treatment that can provide the high level of monitoring and support that is required by this group. People who are highly dependent on medical care may have conditions that are exacerbated by alcohol use and therefore require an abstinence goal. As for adolescents and pregnant women, these people will be referred to other appropriate treatment.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Queensland University of Technology
Primary Sponsor Address: Institute of Health and Biomedical Innovation (IHBI) 60 Musk Avenue Kelvin Grove Urban Village Kelvin Grove, Queensland, 4059 Australia
Primary Sponsor Country: Australia

Trial websitewww.ontrack.org.au

Trial IDACTRN12616001171404

UTNU1111-1172-7434

Contact person for information and recruitmentProf
David Kavanagh
Institute of Health and Biomedical Innovation (IHBI) 60 Musk Avenue Kelvin Grove Urban Village Kelvin Grove, Queensland, 4059 Australia
+61 7 3138 6143

Further information icondavid.kavanagh@qut.edu.au
Australia

Ventilation status of sedated patients in the cardiac catheterisation laboratory

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Trial Information

Trial summary

Respiratory depression is more likely to be detected during sedation when capnography is used. However, sedation-induced respiratory depression is commonly transient and does not always cause patient harm. Randomised controlled trials have produced conflicting results regarding whether capnography improves patient safety when used during sedation. Further research is required to determine whether applying capnography to the conscious sedation context is warranted. One considerable difficulty in designing a trial to determine whether a specific intervention improves the safety of conscious sedation is that adverse sedation events that pose potential risks to patient safety, such as hypoxaemia, should be so rare that it would not be feasible to recruit the required number of participants. In contrast, the number of participants required to detect a clinically significant difference in ventilation status during conscious sedation, as measured by transcutaneous carbon dioxide concentration (TcCO2), would be feasible to recruit in the context of a clinical trial. However, in order to calculate a sample size for such a trial, the expected control group TcCO2 needs to be identified. In this study, continuous TcCO2 measurements will be recorded from patients undergoing procedures with conscious sedation, starting before conscious sedation is induced (for measurement of baseline TcC02) and ceasing at the end of the procedure. 

Broad Health ConditionSedation-induced respiratory depression
Respiratory
Cardiac

Specific Health ConditionAnaesthesiology
Anaesthetics
Respiratory
Other respiratory disorders / diseases
Cardiovascular
Other cardiovascular diseases

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
John Flynn - Gold Coast Private Hospital - Tugun

Hospital
Princess Alexandra Hospital - Woolloongabba

Postcode
4224 - Tugun

Postcode
4102 - Woolloongabba

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Patients undergoing an elective procedure with conscious sedation (intravenous midazolam or midazolam and fentanyl) without an anaesthetist present in a cardiac catheterisation laboratory

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. less than 18 years of age
2. cognitively impaired (due to inability to provide informed consent); or
3. unable to understand and speak English (due to inability to provide written informed consent).
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Queensland University of Technology
Primary Sponsor Address: Queensland University of Technology 60 Musk Ave Kelvin Grove QLD 4059
Primary Sponsor Country: Australia

Trial IDACTRN12616001136493

Contact person for information and recruitmentDr
Aaron Conway
Institute of Health and Biomedical Innovation Queensland University of Technology 60 Musk Ave Kelvin Grove QLD 4059
+61731386124

Further information iconaaron.conway@qut.edu.au
Australia

Optimising the clinical application of capnography for monitoring ventilation of sedated patients in the cardiac catheterisation laboratory

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Trial Information

Trial summary

Respiratory depression is more likely to be detected during sedation when capnography is used. However, sedation-induced respiratory depression is commonly transient and does not always cause patient harm. Randomised controlled trials have produced conflicting results regarding whether capnography improves patient safety when used during sedation and there is considerable variation in the utilisation of capnography monitoring in clinical practice. This project seeks to optimise the implementation of this technology into clinical practice. 
AIMS
1.	To identify subgroups of patients based on their physiological responses to sedation.
2.	To characterise the identified subgroups by determining whether they are associated with particular demographic and clinical characteristics.
3.	To examine variation in clinical interventions applied to support respiratory function between subgroups. 
4.	To determine if there are associations between the subgroups and intra-procedural ventilation status as well as post-procedural outcomes.

Broad Health Conditionsedation-induced respiratory depression

Specific Health ConditionAnaesthesiology
Anaesthetics
Respiratory
Other respiratory disorders / diseases

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
The Wesley Hospital - Auchenflower

Hospital
Holy Spirit Northside - Chermside

Postcode
4066 - Auchenflower

Postcode
4032 - Chermside

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Patients undergoing an elective procedure with moderate sedation (intravenous midazolam or midazolam and fentanyl) without an anaesthetist present in a cardiac catheterisation laboratory

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. less than 18 years of age;
2. cognitively impaired (due to inability to provide informed consent); or
3. unable to understand and speak English (due to inability to provide written informed consent).
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Queensland University of Technology
Primary Sponsor Address: 60 Musk Ave Kelvin Grove QLD 4059
Primary Sponsor Country: Australia

Trial IDACTRN12616001132437

Contact person for information and recruitmentDr
Aaron Conway
Institute of Health and Biomedical Innovation Queensland University of Technology 60 Musk Ave Kelvin Grove QLD 4059
+61731386124

Further information iconaaron.conway@qut.edu.au
Australia

The feasibility and effect of using consumer-based physical activity monitors to improve exercise behaviour in women with Stage II+ breast cancer.

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Trial Information

Trial summary

The primary purpose of this trial is to evaluate the feasibility and efficacy of using Fitbit devices in combination with an individual exercise counselling session to increase physical activity in women with stage II+ breast cancer.

Who is it for?
You may be eligible to participate in this trial if you are aged 18 years or older, and have been diagnosed with stage II+ breast cancer for which you are either currently undergoing treatment, or have finished treatment within the previous 24 months. Participants must also reside or work in greater Brisbane and be insufficiently physically active.

Study details
All participants enrolled in this trial will be randomly allocated (by chance) to receive either an individual exercise counselling session plus use of a Fitbit device for 12 weeks, or to receive only the individual exercise counselling session. The exercise counselling session will involve a 60 minute appointment at an exercise clinic (Queensland University of Technology, Brisbane) with an accredited exercise physiologist to discuss recommended physical activity levels and methods for increasing physical activity. Individuals in the Fitbit group will then be provided with a Fitbit device to use as much as they choose for the following 12 weeks. All participants will then have their physical activity levels assessed (by wearing a small physical activity monitor on their hip) and report on their levels of physical activity in order for researchers to compare between the two groups.

It is hoped that the findings from this study will inform physicians and patients on easily accessible, cost-effective and feasible approaches for maintaining physical activity participation in the absence of supervised exercise in breast cancer patients with a high disease burden.

Broad Health ConditionBreast cancer

Specific Health ConditionCancer
Breast

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Mater Private Hospital - South Brisbane

Hospital
Holy Spirit Northside - Chermside

Hospital
Mater Adult Hospital - South Brisbane

Postcode
4101 - South Brisbane

Postcode
4032 - Chermside

Anticipated date of first participant enrolment22/08/2016

Anticipated date of last participant enrolment23/08/2017

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

To be eligible, women need to be aged 18 years or older (i.e., adults who are able to provide informed consent); reside or work in greater Brisbane (i.e., living within a 60 kilometre radius of the CBD); diagnosed with breast cancer stage II+. The residence criterion will allow for the AEP to travel to participants’ homes for intervention sessions. All participants must be currently undergoing treatment, or recently completed treatment (within the past 24 months). Additionally, women will be assessed on a range of factors to determine their disease burden; eligible participants must currently be insufficiently physical active (that is, engage in <150 minutes of moderate-intensity physical activity per week), plus meet one or more of the following criteria: confirmed clinical diagnosis of: (i) at least one comorbidity or chronic disease (hypertension, hypercholesterolemia, overweight or obese [body mass index > 25 kg/m2], classified as osteopenic or has osteoporosis, type II diabetes), or (ii) at least one chronic breast cancer treatment sequelae (lymphoedema, upper-body morbidity, neuropathy, fatigue, arthralgia). Self-report of moderate- to severe-intensity treatment-sequelae, even in the absence of a clinical diagnosis will also be accecpted. This self-report criterion is necessary since treatment-sequelae are not routinely screened, detected and recorded by follow-up care. These self-report measures are ones that have been included in previous prospective cohort studies. These eligibility criterion will ensure the subgroup of the breast cancer population that have typically been excluded from previous study can participate. That is, this study aims to evaluate women with the characteristics of typical women with later-stage breast cancer. 

Minimum age18 Years

GenderFemales

Can Healthy volunteers participate?No

Key exclusion criteria

Exclusion criteria include: being sufficiently active (that is, currently meet the National physical activity recommendations); stage I disease; planning to become pregnant during the study; plans for additional surgery (e.g., reconstructive) or adjuvant treatment during the study period; unable to provide informed consent. 
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Queensland University of Technology
Primary Sponsor Address: School of Public Health, Institute of Health and Biomedical Innovation, Queensland University of Technology, Victoria Park Road, Kelvin Grove QLD 4059 Australia
Primary Sponsor Country: Australia

Trial IDACTRN12616000954426

UTNU1111-1185-4506

Contact person for information and recruitmentMr
Ben Singh
School of Public Health and Social Work, Queensland University of Technology Victoria Park Road Kelvin Grove QLD 4059
(+617) 3138 3016

Further information iconbenjamin.singh@hdr.qut.edu.au
Australia

Does in-bed cycling with critically ill patients assist to maintain muscle mass and function?

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Trial Information

Trial summary

Critically ill patients often require prolonged mechanical ventilation for periods greater than 48 hours. It has been identified that skeletal muscle wasting occurs early and rapidly during the first week of critical illness. Despite international recommendations to commence activity as early as possible with critically ill patients it has been identified that exercise interventions are rarely initiated when a patient is on mechanical ventilation. This leads to prolonged immobility and may contribute to the development of ICU Acquired Weakness (ICUAW).

A randomised controlled trial (RCT) will compare outcomes of critically ill patients who receive standard physiotherapy (control group) and those who complete additional in-bed cycling intervention sessions. This will enable comparison of outcomes to assist clinicians to determine if additional in-bed cycling sessions may be beneficial with critically ill patients.

Objectives:
To determine:
(1)	if in-bed cycling in addition to standard care is effective in reducing the rate of rectus femoris (RF) cross-sectional area (CSA) atrophy and intensive care unit acquired weakness (ICUAW) in patients requiring > 48 hrs of mechanical ventilation compared to standard care;
(2)	whether in-bed cycling in addition to standard care improved functional and cognitive outcomes in patients requiring > 48 hours of mechanical ventilation compared to standard care.

Trial Design: Two (parallel) arm, preliminary randomised control trial with assessor blinding.

In summary, this study aims to examine if addition of an in-bed cycling intervention with critically ill patients reduces the loss of thigh muscle mass. Also to examine if in-bed cycling improves functional and cognitive outcomes post intensive care discharge.

Broad Health ConditionCritical illness
Intensive Care Unit Acquired Weakness (ICUAW)
Sepsis

Specific Health ConditionPhysical Medicine / Rehabilitation
Other physical medicine / rehabilitation

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Princess Alexandra Hospital - Woolloongabba

Postcode
4102 - Woolloongabba

Anticipated date of first participant enrolment18/07/2016

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Critically ill patients admitted to ICU who are:
(i) expected to require >48 hours of mechanical ventilation,
(ii) able to provide consent or have a family member consent on their behalf,
(iii) enrolled into the study within 96 hours of ICU admission,
(iv) expected to remain in ICU for >48 hours following study enrolment. 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

i)    The presence of a pre-existing condition that is likely to impair mobility or the assessment of mobility following enrolment (e.g. neurological, musculoskeletal, cognitive or mental health disorder likely to impair daily function)
ii)    Diagnosed or suspected acute primary brain lesion (e.g. traumatic brain injury, intracranial haemorrhage, stroke, hypoxic brain injury or neuromuscular disorder) that is likely to impair daily function. 
iii)   Injuries where in-bed cycling would be contraindicated (e.g. some spinal / pelvic / lower limb orthopaedic injuries / open abdominal wound).
iv)   Death is deemed to be imminent or inevitable during this admission 
v)   Obesity (greater than 135 kg) as the maximum weight capacity for the in-bed cycle ergometer is 135 kg. (MOTOmed Letto 2)
vi)   Has acute deep vein thrombosis or pulmonary embolism 
vii)  Acute coronary syndrome (evidence of coronary ischaemia e.g. chest pain or ECG changes)
viii) Uncontrolled seizures or status epilepticus  
ix)   Pregnancy 
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Marc Nickels
Primary Sponsor Address: Physiotherapy Department Princess Alexandra Hospital Ipswich Rd Woolloongabba QLD 4102
Primary Sponsor Country: Australia

Trial IDACTRN12616000948493

Contact person for information and recruitmentMr
Marc Nickels
Physiotherapy Department Princess Alexandra Hospital Ipswich Rd Woollgabba QLD 4102
+61 7 31762401

Further information iconmarc.nickels@health.qld.gov.au
Australia

A randomised control trial of Social Skills Training (SCIT) in those diagnosed with psychosis.

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Trial Information

Trial summary

The social cognition training (SCIT) is a groupbased therapy that has a goal of improving thinking skills about social situations for individuals with psychotic disorders. Two trained therapists deliver the group over 12 weekly sessions, with each session lasting approximately 2 hours. Participants will be able to attend one of the sites convenient to where they live. The therapy involves education about emotions and social interaction using games and technology such as watching DVD’s. Participants will be asked to attend a clinical assessment at three times points (beginning of the study, end of study and 3 months post study)that will take approximately 2 hours of their time. The clinical assessment will include tests of thinking and problem solving skills, and questions about how people think in social situations and skills in identifying emotions from photographs of people. At the completion of the entire study, a summary of the results will be sent out to participants informing them of the outcomes of the study. 

Broad Health ConditionPsychosis
Schizophrenia
Schizophreniform psychosis
Delusional disorder
Bipolar disorder
Psychosis not otherwise specified

Specific Health ConditionMental Health
Psychosis and personality disorders
Mental Health
Schizophrenia

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Aged between 18 and 65 years (inclusive).
2. Fulfil the DSM-IV criteria practice for broadly defined early psychosis, based on the Diagnostic Interview for Psychosis. This includes diagnoses such as schizophrenia, schizophreniform psychosis, delusional disorder, bipolar disorder, psychosis not otherwise specified. 
3. Have a premorbid functioning IQ of 71 or above 
4. Have a social functioning scale - communication score below 105
5. Have an educational attainment of Grade 4 or above 
6. Agree to participate, has capacity to consent and able to follow the study instructions and procedures.

Minimum age18 Years

Maximum age65 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Have a premorbid functioning IQ of 70 or below
2. Have a social functioning scale - communication score above 106
3. Have an educational attainment of Grade 3 or below
4. Being unable to understand study demands and therefore not being able to consent appropriately. 
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: The University of Queensland
Primary Sponsor Address: St Lucia, QLD, 4072
Primary Sponsor Country: Australia

Trial IDACTRN12616000866404

Contact person for information and recruitmentMs
Andrea Baker
Level 3, Dawson House The Park Centre for Mental Health Corner Ellerton Drive and Wolston Park Road Wacol Queensland 4076
+61732718660

Further information iconandrea_baker@qcmhr.uq.edu.au
Australia

S.A.F.E. Study: Safety And Feasibility of Exercise for women with breast cancer

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Trial Information

Trial summary

The primary purpose of this trial is to evaluate the safety and feasibility of exercise in women who are either undergoing treatment or have recently completed treatment for Stage II+ breast cancer. 
Who is it for?
You may be eligible to participate in this trial if you are aged 18 or over, reside or work in greater Brisbane, and have been diagnosed with stage II+ breast cancer for which you are either still undergoing treatment, or completed treatment within the last 24 months. All participants must also report at least one cancer-related or treatment-related health condition, e.g. fatigue, obesity, high blood pressure etc. 
Study details 
All participants in this trial will be randomly allocated (by chance) to receive the exercise program at enrolment, or 12 weeks following enrolment. The exercise program lasts for 12 weeks and involves completing 150 minutes of moderate intensity aerobic and resistance exercise under the guidance of an accredited exercise physiologist (an allied health professional with expertise in prescribing exercise to people with chronic diseases). Supervised session (between 5 and 20 sessions) will be scheduled for a time and location that is convenient to each participant. Participants will be asked to report any side effects of the treatment and complete questionnaires and function/fitness testing to evaluate the exercise program. 
It is hoped that the findings from this study will inform physicians and patients on the safety and feasibility of exercise in breast cancer patients with a high disease burden, in the hopes that it may be prescribed as a safe and effective adjuvant therapy for these patients to improve function, quality of life and survival.

Broad Health ConditionStage II+ Breast Cancer
Breast Cancer treatment-related sequelae

Specific Health ConditionCancer
Breast

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Mater Adult Hospital - South Brisbane

Hospital
Holy Spirit Northside - Chermside

Hospital
Mater Private Hospital - South Brisbane

Postcode
4101 - South Brisbane

Postcode
4032 - Chermside

Postcode
4102 - Woolloongabba

Anticipated date of first participant enrolment2/05/2016

Anticipated date of last participant enrolment31/08/2017

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Women aged 18 years or older (i.e., adults who are able to provide informed consent); reside or work in greater Brisbane (i.e., living within a 60 kilometre radius of the CBD); diagnosed with breast cancer stage II+; treated at one of the referring hospitals. The residence criterion will allow for the Accredited Exercise Physiologist (AEP) to travel to participants’ homes for intervention sessions. All participants must be undergoing or have completed treatment within the past 24 months, with the exception of hormone therapy. Additionally, women will be assessed on a range of factors to determine their disease burden; eligible participants must currently not meet national physical activity level recommendations (<150 minutes of weekly physical activity) PLUS meet one or more of the following criteria: confirmed clinical diagnosis of: (i) at least one co-morbidity or chronic disease (hypertension, hypercholesterolemia, overweight or obese [body mass index>25], classified as osteopenic or has osteoporosis, type II diabetes), or (ii) at least one chronic breast cancer treatment sequelae (lymphoedema, upper-body morbidity, neuropathy, fatigue, arthralgia). We will also accept self-report of moderate to severe in intensity treatment sequelae, even in the absence of a clinical diagnosis. This self-report criterion is necessary since treatment-sequelae are not routinely screened, detected and recorded by follow-up care (Cheville et al. 2012). Our self-report measures are ones that we have included our prospective cohort studies. 

Minimum age18 Years

GenderFemales

Can Healthy volunteers participate?No

Key exclusion criteria

Exclusion criteria: Currently meeting the current exercise recommendations (i.e., sufficiently active); stage I disease; planning to become pregnant during the study; plans for additional surgery (e.g., reconstructive) during the study period; unable to consent.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Queensland University of Technology
Primary Sponsor Address: School of Public Health, Institute of Health and Biomedical Innovation, Queensland University of Technology Victoria Park Road, Kelvin Grove QLD 4059 Australia
Primary Sponsor Country: Australia

Trial IDACTRN12616000547448

UTNNA

Contact person for information and recruitmentDr
Rosa Spence
School of Public Health and Social Work, Queensland University of Technology Victoria Park Road Kelvin Grove QLD 4059
(+617) 3138 3016
(+617) 3138 3130
Further information iconrosa.spence@qut.edu.au
Australia

A non-blinded, randomised, controlled, superiority trial of StrataXRT 'Registered Trademark' versus 10% Glycerine (Sorbolene) cream for prophylaxis and management of radiation dermatitis in head and neck cancer patients receiving radical radiotherapy with or without concurrent systemic therapy

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Trial Information

Trial summary

The primary purpose of this trial is to investigate the efficacy of StrataXRT in reducing the incidence and rate of onset of radiation dermatitis in head and neck cancer patients undergoing radiotherapy. 
Who is it for? 
You may be eligible to participate in this trial if you are aged 18 or over, and have been diagnosed with a head or neck cancer for which you are receiving radiotherapy (>50Gy) with or without concurrent chemotherapy or biotherapy. 
Study details 
Participants enrolled in this trial will be randomly allocated (by chance) to receive either StrataXRT gel or 10% Glycerine (Sorbolene). The allocated dressing will be applied to the irradiated skin, twice a day until the skin reaction subsides, up to 4 weeks post treatment. Participants will complete a range of questionnaires by interview every week from the start of radiotherapy and four weeks following the completion of radiotherapy, in addition to collecting data on radiation dermatitis symptoms, healthcare costs and side effects. It is hoped that results from this trial will provide information on whether StrataXRT is more safe and effective than Sorbolene for the prevention and treatment of radiation dermatitis in head and neck cancer patients undergoing radiotherapy.

Broad Health ConditionHead and Neck Cancer

Specific Health ConditionCancer
Head and neck

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Royal Brisbane & Womens Hospital - Herston

Postcode
4029 - Royal Brisbane Hospital

Anticipated date of first participant enrolment30/05/2016

Anticipated date of last participant enrolment2/06/2017

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Participants in this study will be patients receiving radical radiotherapy +/- concurrent chemotherapy or biotherapy for head and neck cancer at the Royal Brisbane and Women's Hospital
*Age >18 years
*Patients who have a definitive diagnosis of head and neck cancer
*Patients who are receiving radiotherapy (>50 Gy) either as primary treatment or postoperative treatment to their head and neck. 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

*Patients who are unable to consent
*Patients with pre-existing skin rash, ulceration or open wound in the treatment area
*Patients with known allergic and other systemic skin diseases even not directly affecting irradiated fields.
*Patients with any known allergic reactions towards any ingredient of either the StrataXRT 'Registered Trademark' or the Sorbolene and failed the patch test.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Queensland University of Technology
Primary Sponsor Address: Level 4, 88 Musk Ave, Kelvin Grove, QLD 4059, Australia
Primary Sponsor Country: Australia

Trial websiteN/A

Trial IDACTRN12616000511437

UTNNil known

Contact person for information and recruitmentA/Prof
Raymond Chan
Level 2, Building 34, Royal Brisbane and Women's Hospital, Butterfield Street, QLD 4029, Australia
+61736462653

Further information iconRaymond.Chan@qut.edu.au
Australia

Test of motivational treatments to reduce alcohol use.

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Trial Information

Trial summary

This study is the first large-scale trial of Functional Imagery Training (FIT). FIT aims to enhance the effectiveness of existing best treatment for alcohol use, Motivational lnterviewing (MI), by harnessing the motivational power of mental imagery. Alcohol misuse is a high prevalence problem with substantial health and social impacts. This study examines the additive effect of embedding FIT techniques within MI when treating Alcohol Use Disorder.

A total of 480 participants who are drinking >4 standard drinks per day on  average and who meet criteria for DSM-5 Alcohol Use Disorder will be recruited and randomly allocated to one of the following three treatment
groups:

1. Motivational Interviewing (MI) – delivered by phone in 2 calls over 1 week. Treatment contact time totals 2 hours. Participants discuss the advantages and feasibility of reducing drinking, and therapists elicit emotional reactions and dissonance between core values and current behaviour.

2. Motivational Interviewing plus Support (MI+S) – delivered by phone in 8 calls over 25 weeks. Treatment contact time totals 3.5 hours. MI+S has the same initial sessions as MI. Later calls offer non-specific support and social reinforcement for progress and encourage brief relaxation practice, but do not shape new coping strategies unless a lapse occurs. A smartphone app assists practice of progressive muscular relaxation, including an audio file to guide practice and photos of peaceful nature scenes.

3. Functional Imagery Training (FIT) – delivered by phone in 8 calls over 25 weeks. Treatment contact time totals 3.5 hours. Is based on MI+S but uses imagery throughout the sessions. During sessions, participants generate multisensory images about positive outcomes from controlling drinking, past success with self-control, and strategies to control drinking. Later sessions elicit achievements, outcomes and effective strategies, rehearsing imagery and making it routine by linking it to daily tasks. Mindfulness is
practised instead of relaxation. A smartphone app assists practice of imagery, including an audio file to guide practice and the ability to take photos to facilitate practice.

Participants complete assessments at Baseline and at 3, 6, and 12 months post-Baseline. Follow-up assessors are blind to treatment condition.

Broad Health ConditionAlcohol Use Disorder

Specific Health ConditionMental Health
Addiction

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Anticipated date of first participant enrolment3/05/2016

Anticipated date of last participant enrolment29/12/2017

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Participants will be aged 18 years or over and report consuming >40 gm of ethanol (4 standard drinks)/day on average in the past 4 weeks. They will fulfil criteria for current DSM-5 Alcohol Use Disorder and deny intravenous drug use or >twice-weekly cannabis use in the last month. They will not be in concurrent psychological treatment for substance use, and if on naltrexone or acamprosate, will have been on a stable dose for >4 weeks. If highly dependent on alcohol or drinking >700 gm ethanol/week, they will obtain a medical assessment and agree to any medical treatment that is needed, including a medically supervised detoxification if required. They must have access to a smartphone to be able to use the treatment app.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Exclusion criteria include insufficient English to read or converse without translation, pregnancy or high dependence on medical care, unmodified hearing impairment, significant cognitive deficit, history of >3 days of psychosis, and acute current suicidality.
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Professor David J. Kavanagh
Primary Sponsor Address: Centre for Children's Health Research, 62 Graham St, South Brisbane QLD 4101
Primary Sponsor Country: Australia

Trial websiteUnder development

Trial IDACTRN12616000480482

UTNNone

Contact person for information and recruitmentDr
Jennifer Connolly
Centre for Children's Health Research, 62 Graham St, South Brisbane QLD 4101
+61 7 3069 7543

Further information iconjennifer.connolly@qut.edu.au
Australia

Benefits of Exercise Physiology Services for Type II Diabetes: The BEST Study

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Trial Information

Trial summary

Currently, there is very little collective evidence on the efficacy of AEP-led exercise
interventions “in practice” for people with chronic disease. This project aims to determine the effectiveness of services provided by Accredited Exercise Physiologists (AEP) for clients with type 2 diabetes on sustained participation on physical activity and clinical markers.
Clients with type 2 diabetes who are referred by their General Practitioner to one of the
participating Exercise Physiology clinics will be recruited for this study. Their outcomes will be compared to those of a control group that do not receive a referral but who are willing to undergo the same battery of assessments on two occasions. 

Broad Health ConditionType 2 Diabetes

Specific Health ConditionMetabolic and Endocrine
Diabetes

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,QLD,SA,TAS,WA,VIC

Anticipated date of first participant enrolment4/04/2016

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Adults with a prior diagnosis of type 2 diabetes mellitus.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Individuals without a diagnosis of type 2 diabetes mellitus, those who are clinically unstable with contraindications to exercise or who are already engaged in high levels of physical activity, or those with a cognitive impairment or intellectual disability that prevents them from providing informed consent to participate.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: University of Tasmania
Primary Sponsor Address: School of Health Sciences Locked Bag 1322 Launceston TAS 7250
Primary Sponsor Country: Australia

Trial IDACTRN12616000264482

Contact person for information and recruitmentDr
Andrew Williams
School of Health Sciences University of Tasmania Locked Bag 1322 Launceston TAS 7250
+61 3 6324 5487

Further information iconAndrew.Williams@utas.edu.au
Australia

Improving immunisation timeliness in infants and young children

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Trial Information

Trial summary

The uptake and timeliness of the primary immunisation series in infancy is critical to preventing infectious diseases morbidity and mortality. There is a high burden of vaccine preventable diseases in Aboriginal and Torres Strait Islander children irrespective of geographic location, however limited attention has been paid to those living in urban and regional settings. The need to improve the timeliness of the primary series has been known for at least 10 years but there has been little change over that time.  Recent data from a cohort of Aboriginal and Torres Strait Islander children in Caboolture, Queensland suggests approximately 44% of children have not completed the primary series by 7 months of age. Identifying simple, culturally appropriate and cost effective interventions to improve timeliness is therefore a priority. This trial aims to To evaluate the effectiveness of targeted, culturally appropriate short messaging service (SMS) and/or home visiting in improving the uptake and timeliness of the primary immunisation series in urban/regional Aboriginal and Torres Strait Islander children

Broad Health ConditionVaccine Preventable Diseases
Immunisation Delivery
Immunisation Coverage

Specific Health ConditionPublic Health
Other public health

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Anticipated date of first participant enrolment19/04/2016

Anticipated date of last participant enrolment30/06/2018

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

(i) Mother in the 2nd or 3rd trimester of pregnancy
(ii) Not planning to move from the study area until the infant turns 8 months of age
(iii) Access to a mobile phone
(iv) Provision of written informed consent from the mother
(v) Caboolture Community Medical l or Carbal are the family’s usual health care provider.
(vii) For the RCT component, a live born infant

Minimum age12 Years

Maximum age45 Years

GenderFemales

Can Healthy volunteers participate?Yes

Key exclusion criteria

None will apply
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Queensland University of Technology
Primary Sponsor Address: 80 Musk Ave Kelvin Grove, Queensland, 4059
Primary Sponsor Country: Australia

Trial websiteNone

Trial IDACTRN12616000204448

UTNU1111-1179-5906

Contact person for information and recruitmentDr
Kerry-Ann O'Grady
Respiratory infection Outreach and Research Team L7, Centre for Children's Health Research 62 Graham Street South Brisbane QLD 4010
+61 7 3069 7270

Further information iconkerryann.ogrady@qut.edu.au
Australia

Feasibility study – Identification of Prostate Cancer Recurrence Sites by [68Ga]Gallium-labelled Prostate Specific Membrane Antigen Binding Ligand Positron Emission Tomography/Magnetic Resonance Imaging (PSMA PET/MRI) in Men with Biochemical Recurrence Following Definitive Therapy

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Trial Information

Trial summary

The study aims to evaluate the sensitivity and specificity of Prostate Cancer Recurrence Sites by [68Ga]Gallium-labelled Prostate Specific Membrane Antigen Binding Ligand Positron Emission Tomography/Magnetic Resonance Imaging (PSMA PET/MRI) in Men with Biochemical Recurrence Following Definitive Therapy. 

Who is it for? You may be eligible to join this study if you are a male aged 18 years or above with pathologically diagnosed prostate cancer and biochemical cancer recurrence. 

Study details: All participants will undergo [68Ga]Gallium-labelled Prostate Specific Membrane Antigen Binding Ligand Positron Emission Tomography/Magnetic Resonance Imaging (PSMA PET/MRI). If the scans demonstrate a lesion that is amenable to biopsy or surgery, the participants will undergo CT or ultrasound guided biopsy or surgical excision as part of their clinical management. Once a sample has been obtained, the 1st sample will be used for immunohistologic analysis and the 2nd sample will be sent for in vitro culture and further analyses. If archived tissues are available, genomic comparison of primary tumour specimens and metastatic/recurrent lesions will be performed. 
At 6, 12, 18 and 24 months after the 68Ga-HBED-CC PET/MRI, relevant prostate cancer data will be used for further analysis. The information will include blood tests (Prostate Specific Antigen, Full Blood Count, Urea and Electrolytes, Calcium, Liver Function Tests), imaging (CT, PET, MR or Bone scan) and clinical history. 
The novel imaging technology may identify evidence of metastatic disease, undetected by standard of care imaging. This information could alter the treatment plan potentially. The benefits of the translational aspects of the study are that a proof of principle precision medicine program may be established to attempt in vitro assessment of a patients’ tumour in a clinically relevant timeframe and to also develop novel cell lines for basic research. This may lead in the future to a larger trial utilizing such data to guide treatment decisions in men with advanced prostate cancer.

Broad Health ConditionProstate cancer

Specific Health ConditionCancer
Prostate

Trial FocusDiagnosis

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Greenslopes Private Hospital - Greenslopes

Anticipated date of first participant enrolment1/03/2016

Anticipated date of last participant enrolment30/06/2017

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Male patients with pathologically diagnosed prostate cancer
2.	Biochemical Recurrence as defined:
a.	PSA > 0.2ng/ml on at least 2 occasions post radical prostatectomy
b.	PSA 2.0ng/ml above nadir 2 years post radiotherapy
3.	History of primary treatment for prostate cancer no sooner than 3 months post-surgery and 2 years post radiotherapy
4.	No known problems with peripheral intravenous or central line access
5.	Able to provide informed signed consent

Minimum age18 Years

GenderMales

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Age under 18 years
2.	Administered a radioisotope within 5 physical half-lives prior to study enrolment
3.	Unable to lie flat during or unable to tolerate PET/MRI
4.	Prior history of any other malignancy within last 2 years
5.	Contraindication to PET scan or [68Ga]Gallium-labelled PSMA ligand 
6.	Claustrophobia not manageable by oral sedatives i.e. Temazepam
7.	Renal impairment or haemodialysis.
8.	Contraindication to biopsy of identified lesion
9.         Contraindication to MRI such as implantable medical devices
10. 	Body weight above 150kg or axial diameter larger than 60cm
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Queensland University of Technology
Primary Sponsor Address: 2, George Street, Brisbane, QLD 4122
Primary Sponsor Country: Australia

Trial IDACTRN12616000186459

Contact person for information and recruitmentDr
Ian Vela
Department of Urology, Princess Alexandra Hospital, 199 Ipswich Rd, Brisbane QLD 4102
+61 7 31766946

Further information iconianvela@me.com
Australia

Using thermal clothing to reduce heart failure morbidity during winter: a randomised controlled trial

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Trial Information

Trial summary

Winter is a surprisingly dangerous time in Australia with greatly increased rates of death and hospitalisation. Winter death rates are 47% higher for heart failure and 32% higher for hypertensive disease compared with summer. Warm countries like Australia have a far greater winter increase in morbidity and mortality than cold countries like Sweden. This is because many Australian homes are inadequately insulated or heated, with indoor temperatures in winter often below 18 degrees C. This cold exposure increases blood pressure and inflammatory factors, which increases the risk of an acute cardiovascular event. 
Home insulation and heating have both been proven to improve cardiovascular health and wellbeing during winter. This study will test if personal insulation also improves cardiovascular health. Heart failure patients will be randomised to receive no intervention or a pack containing thermal tops, hats and socks, indoor temperature monitors, and advice on when to wear the thermals. Our primary hypothesis is that winter hospital admissions will be reduced, and we will also examine improvements in blood pressure, inflammatory factors, quality of life, sleep and personal insulation.
This will be the world’s largest study of the health benefits of personal insulation, and will build on our work with heart failure patients at The Prince Charles Hospital. Thermal clothes are a cheap and simple intervention that could greatly reduce winter morbidity and mortality across Australia.

Broad Health ConditionHeart Failure

Specific Health ConditionCardiovascular
Other cardiovascular diseases

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
The Prince Charles Hospital - Chermside

Postcode
4032 - Chermside

Anticipated date of first participant enrolment1/04/2016

Anticipated date of last participant enrolment31/05/2016

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Have a diagnosis of either systolic or diastolic heart failure

Minimum age50 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Are pregnant (highly unlikely).
2. A serious co-morbidity (e.g., cancer) or a serious physical impairment that prevents the participant from dressing themselves.
3. Live in a residential care facility.
4. Are unable to give informed consent.
5. Were involved in our previous pilot.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Queensland University of Technology
Primary Sponsor Address: 60 Musk Avenue, Kelvin Grove, Queensland 4059
Primary Sponsor Country: Australia

Trial IDACTRN12615001023549

Contact person for information and recruitmentA/Prof
Adrian Barnett
Queensland University of Technology, 60 Musk Avenue, Kelvin Grove, Queensland 4059
+61731386010

Further information icona.barnett@qut.edu.au
Australia