Search results from the Australian New Zealand Clinical Trials Registry

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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

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 randomised controlled trial

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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

Hospital
Redcliffe Hospital - Redcliffe

Postcode
4029 - Herston

Postcode
4020 - Redcliffe

Anticipated date of first participant enrolment27/02/2017

Anticipated date of last participant enrolment30/04/2018

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

All ICU patients = or > 18years who have a NGT and/or ETT in situ.
Expected to remain in ICU > 24 hours 
NGT or ETT inserted a maximum of 12 hours prior to ICU admission
Wide bore NGT in situ (NGT group only)

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Burn patients with an ETT wired in place (ETT group only)
Patients with facial trauma
Traumatic brain injured patients requiring intracranial pressure monitoring and/or ventricular drainage of cerebrospinal fluid
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

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 enrolment21/04/2017

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

Morning versus evening exercise: Its effect on body composition and weight loss

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Trial Information

Trial summary

Overweight individuals use exercise primarily as a means to reduce body weight. Given the continued rise in the prevalence of overweight and obesity (Hill et al., 2012; Ziauddeen et al., 2015), optimising the benefits of exercise for weight loss is crucial. In recognition of this, evidence-based recommendations for exercise prescription including frequency, intensity, mode, duration, pattern, and volume have been developed (Donnelly et al., 2009; Garber et al., 2011). Similarly, some countries have established guidelines for minimum physical activity levels required for weight maintenance and weight loss (Donnelly et al., 2009; insert OZ ref). However, there is no such recommendation for the optimal time-of-day at which exercise should be performed to maximise its impact on weight loss.

Circadian rhythms regulate several physiological processes that influence appetite, sleep/wake cycles and exercise performance (Almoosawi et al., 2013; Drust et al., 2005; Froy, 2007; Thun et al., 2015; Winget et al., 1985; Youngstedt et al., 2002), therefore, it is possible that individuals will respond differently when exercise is performed in the morning, compared to the evening. However, the majority of available exercise-based weight loss research either does not control, or does not report, the time-of-day at which exercise has been prescribed. Therefore, the implications of exercise time-of-day for weight loss are unknown.

The aim of this chapter is to present an overview of the available literature including observational and experimental studies in the area of exercise timing and its potential effects on body weight and composition. Additionally, some discussion surrounding the physiological responses to exercise and circadian rhythm of hormones will be presented to provide additional insight to understand the mechanisms behind the time-of-day effect on body weight and composition

Broad Health ConditionOverweight
Obesity

Specific Health ConditionDiet and Nutrition
Obesity
Public Health
Health promotion/education

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Anticipated date of first participant enrolment2/05/2016

Anticipated date of last participant enrolment3/07/2017

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Participants will be recruited based on the following inclusion criteria:
i.	be aged between 18 and 60 years
ii.	have a body mass index greater than or equal to 25 kg/m2
iii.	be insufficiently active, defined as participating in less than 150 minutes of MVPA per week (by self-report)
iv.	have been weight stable in the previous 3 months (+/-3 kg by self-report)
v.	otherwise healthy and cleared for exercise based on the Exercise and Sports Science Australia Adult Pre-Exercise Screening System

Minimum age18 Years

Maximum age60 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

Participants will be excluded based on any of the following criteria:
i.	participate in shift work
ii.	are pregnant or expecting to be pregnant during the study period
iii.	taking any medication that would affect food intake, appetite or physical activity levels, weight loss, or metabolism
iv.	have a body weight greater than 150 kg, due to limitations of the DXA machine

Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: The University of Queensland
Primary Sponsor Address: School of Human Movement and Nutrition Sciences (#26B) Cnr Blair Drive & Union Road The University of Queensland, St Lucia Campus Brisbane Qld 4072
Primary Sponsor Country: Australia

Trial websitehttp://exercisetimeofday.wix.com/paige

Trial IDACTRN12616000457448

UTNU1111-1181-4912

Contact person for information and recruitmentMiss
Paige Brooker
School of Human Movement and Nutrition Sciences (#26B) Cnr Blair Drive & Union Road, The University of Queensland, St Lucia Campus Brisbane Qld 4072
+61 406773998

Further information iconp.brooker@uq.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

A randomised controlled trial of forced air warming for patients undergoing interventional cardiology procedures with sedation

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Trial Information

Trial summary

Hypothermia is a known adverse effect of general and regional anaesthesia. It is associated with increased risk of complications including surgical site infections and bleeding. For this reason, it is recommended that strategies are implemented to prevent hypothermia. The most effective strategy is forced-air warming. Of note, with advances in medical technology continuing to expand the indications for minimally invasive surgical techniques, sedation is likely to be increasingly used for many procedures that once could only be performed with general anaesthesia. Interventions to prevent hypothermia from occurring, such as forced air warming, are not currently used for sedated patients. Yet, we recently observed in one of our previous studies that about one quarter of patients undergoing procedures with sedation were hypothermic after their procedure. Sedated patients who become hypothermic may be at similar risk of developing complications, like infections and bleeding, to those patients who undergo a general or regional anaesthetic. As such, investigation of the clinical benefits of preventing hypothermia in sedated patients is required. This research aims to determine whether forced air warming reduces hypothermia in sedated patients. The results could potentially benefit the large number of patients undergoing interventional procedures with sedation.

Broad Health Conditionsedation
hypothermia

Specific Health ConditionAnaesthesiology
Other anaesthesiology
Cardiovascular
Other cardiovascular diseases

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD

Hospital
The Wesley Hospital - Auchenflower

Hospital
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst

Anticipated date of first participant enrolment1/02/2016

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Patients undergoing an interventional procedure for cardiovascular disease in the Cardiac Catheter Theatres at The Wesley Hospital and the Cardiac Catheter Laboratory at St Vincent’s Private Hospital, Sydney that is expected to require sedation and be of more than 30 minutes duration will be included. Interventional procedures include percutaneous coronary interventions, implantation of cardiac rhythm management devices (e.g. permanent pacemaker, implantable cardioverter-defibrillator) and ablation of cardiac arrhythmias.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Patients will be excluded from the study if they:

-are less than 18 years of age;
-are cognitively impaired (due to inability to provide informed consent); 
-are unable to understand and speak English (due to inability to provide written informed consent); 
-are undergoing an emergency procedure (e.g. percutaneous coronary intervention for ST elevation myocardial infarction);
-are undergoing a diagnostic procedure (e.g. coronary angiogram, electrophysiology study without ablation);
-have a current temperature above 37.5 degrees C;
-are scheduled for general anaesthesia.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Queensland University of Technology
Primary Sponsor Address: Institute of Health & Biomedical Innovation 60 Musk Ave Kelvin Grove QLD 4059
Primary Sponsor Country: Australia

Trial IDACTRN12616000013460

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

Further information iconaaron.conway@qut.edu.au
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

Randomised Control Trial of the Learn to Be Safe with Emmy and FriendsTM Program: Evaluating Changes in Protective Behaviours Knowledge, Intentions and Disclosure of First Grade Students

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Trial Information

Trial summary

A two-arm cluster randomised controlled trial will be conducted examining the effectiveness of the Learn to Be Safe with Emmy and Friends protective behaviours program as compared to a waitlist control group in Queensland, Australia. Participants will be children in first grade classrooms at three locations. The Learn to Be Safe with Emmy Program consists of 5 one-hour weekly sessions teaching protective behaviour concepts such as emotions, safe/unsafe secrets, private/public body parts, early warning signs and disclosure networks. Waitlist control students will participate in educational activities as normally scheduled. Data will be collected at baseline, 6 weeks post-baseline (intervention completion) and 6 month follow-up for both conditions, with additional 1 year, and 18 month follow-ups for the program condition. Outcomes will include protective behaviours knowledge, intentions and skill.

Broad Health ConditionEnhancing protective behaviours

Specific Health ConditionPublic Health
Health promotion/education
Mental Health
Studies of normal psychology, cognitive function and behaviour

Trial FocusEducational / counselling / training

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Postcode
4222 - Griffith University

Postcode
4213 - Mudgeeraba

Postcode
4228 - Tallebudgera

Postcode
4223 - Currumbin

Postcode
4217 - Benowa

Postcode
4212 - Helensvale Town Centre

Postcode
4210 - Oxenford

Postcode
4209 - Upper Coomera

Postcode
4811 - James Cook University

Postcode
4807 - Ayr

Postcode
4814 - Garbutt

Postcode
4211 - Gaven

Postcode
4211 - Nerang

Postcode
4223 - Currumbin Valley

Postcode
4810 - Belgian Gardens

Postcode
4216 - Coombabah

Postcode
4226 - Merrimac

Postcode
4109 - Macgregor

Postcode
4109 - Sunnybank

Postcode
4113 - Runcorn

Postcode
4816 - Woodstock

Postcode
4817 - Kirwan

Postcode
4814 - Cranbrook

Postcode
4811 - Oonoonba

Postcode
4211 - Pacific Pines

Anticipated date of first participant enrolment16/02/2015

Anticipated date of last participant enrolment10/01/2017

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

All first grade children participating in Learn to BE SAFE with Emmy program or on waitlist for program. 

Minimum age5 Years

Maximum age7 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

Previous participation in a protective behaviours program. No parental or child consent. 
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Griffith University
Primary Sponsor Address: Parklands Drive Southport, Qld Gold Coast campus GRIFFITH UNIVERSITY QLD 4222
Primary Sponsor Country: Australia

Trial IDACTRN12615000917538

UTNU1111-1160-8333

Contact person for information and recruitmentProf
Melanie Zimmer-Gembeck
Griffith University School of Applied Psychology, G40 Parklands Dr Southport Qld 4222
+61 7 56789085

Further information iconm.zimmer-gembeck@griffith.edu.au
Australia

CHERISH Collaborative for Hospitalised Elders: Reducing the Impact of Stays in Hospital

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Trial Information

Trial summary

Older people (age 65 and older) account for more than half of hospital bed days, and have longer stays and more hospital adverse events that younger people. A hospital stay is often a decisive point in an older person’s health, with hospitalisation accounting for half of newly acquired disability in elders. Geriatric syndromes (including delirium, functional decline, falls, incontinence and pressure injury) result in longer hospitalisations and greater risk of death and institutionalisation. Research clearly shows that “simple” strategies (early mobilisation, adequate oral nutrition, and meaningful cognitive activities) are effective to reduce geriatric syndromes, improve outcomes and reduce costs. While such strategies have been effectively incorporated in specialist “acute care for elders” wards, only a limited number of patients have access to these specialist services. In order to optimise care we need to embed these principles in all acute wards caring for older people. However, this requires systematic changes in acute care staff attitudes, practices and systems of care.

We have piloted a programme of enabling facilitation, based on the i-PARIHS implementation framework, to embed this evidence into practice. The “Eat Walk Engage” programme supports a ward-based multidisciplinary team to identify barriers, trial solutions and embed successful strategies into practice using evidence-based quality improvement methods. In two pilot wards at the Royal Brisbane and Women’s Hospital we have shown promising reductions in length of stay, geriatric syndromes and adverse events accompanying process improvements. 

The CHERISH (Collaborative for Hospitalised Elders: Reducing the Impact of Stays in Hospital) study is a cluster randomised controlled trial of the “Eat Walk Engage” programme across 4 sites, and will provide robust evidence of the transferability, scalability, effectiveness and cost-effectiveness of the programme to inform further implementation. Comparing 4 intervention wards with  control wards in the same hospitals to account for other sources of variation, we aim to demonstrate a reduction in hospital stay, geriatric syndromes, and discharge to a higher level of care within 12 months of implementing the “Eat Walk Engage” programme. The project is supported by a Queensland Accelerate Partnership Grant from the Department of Science, Information Technology, Innovation and the Arts, administered by Queensland University of Technology.

Broad Health Conditiondelirium
functional decline
malnutrition

Specific Health ConditionPublic Health
Health service research

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Royal Brisbane & Womens Hospital - Herston

Hospital
Nambour General Hospital - Nambour

Hospital
The Prince Charles Hospital - Chermside

Hospital
Caboolture Hospital - Caboolture

Anticipated date of first participant enrolment28/08/2015

Anticipated date of last participant enrolment31/03/2017

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Admitted to hospital for 3 or more days, with admission to nominated intervention or control ward

Minimum age65 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Discharged from hospital within 2 days; palliative intent of care
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Professor Alison Mudge
Primary Sponsor Address: Building C28 Level 1 Roal Brisbane and Women's Hospitals Herston Queensland 4029
Primary Sponsor Country: Australia

Trial IDACTRN12615000879561

UTNU1111-1169-4943

Contact person for information and recruitmentMs
Prue McRae
Building C28 Level 1 Royal Brisbane and Women's Hospitals Herston Queensland 4029
61736460787

Further information iconPrue.McRae@health.qld.gov.au
Australia

Tailored Patient Education for Preventing Falls after Hospital Discharge

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Trial Information

Trial summary

Falls are the leading cause of injury-related hospitalisation in older people in Australia. Older people are at increased risk of falls after hospital discharge and these falls can lead to injury and loss of independence and quality of life. However older people have been found to have low levels of knowledge about falls and may be reluctant to engage in falls prevention activities, such as exercise.  

The primary aim of this trial is to determine if providing tailored falls prevention education that includes the provision of multimedia materials as well as individual health professional consultations and reinforcement in hospital and after discharge reduces falls rates in older people after discharge from hospital. A randomised trial will compare outcomes between a group that receive the education in addition to usual care and a group that receive social visits in addition to usual care.

Broad Health ConditionAccidental falls
Functional ability
Health related quality of life

Specific Health ConditionInjuries and Accidents
Other injuries and accidents
Physical Medicine / Rehabilitation
Other physical medicine / rehabilitation

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
WA

Hospital
Bentley Health Service - Bentley

Hospital
Armadale Kelmscott Memorial Hospital - Armadale

Hospital
Swan Districts Hospital - Middle Swan

Postcode
6053 - Bayswater

Postcode
6054 - Ashfield

Postcode
6054 - Eden Hill

Postcode
6056 - Midland

Postcode
6058 - Forrestfield

Postcode
6070 - Darlington

Postcode
6102 - Bentley

Postcode
6104 - Redcliffe

Postcode
6101 - East Victoria Park

Postcode
6107 - Queens Park

Postcode
6110 - Gosnells

Postcode
6111 - Kelmscott

Postcode
6112 - Armadale

Postcode
6111 - Karragullen

Postcode
6110 - Southern River

Postcode
6001 - Perth

Anticipated date of first participant enrolment29/07/2015

Anticipated date of last participant enrolment26/09/2016

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Inpatient rehabilitation ward being discharged from hospital within one week of enrolment into study
Discharged to community dwelling setting
Able to provide written informed consent

Minimum age60 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Discharge is to hostel or nursing home
Any diagnosis of cognitive impairment or confusion
Under care of palliative or mental health medical officer
Hearing impairment that precludes receiving telephone call
Readmission to hospital within last 14 days
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: The University of Notre Dame Australia
Primary Sponsor Address: 19 Mouat St, PO Box 1225 Fremantle WA 6959
Primary Sponsor Country: Australia

Trial IDACTRN12615000784516

UTNU1111-1169-4492

Contact person for information and recruitmentA/Prof
Anne-Marie Hill
School of Physiotherapy and Exercise Science, Curtin University Kent St, Bentley WA Australia, 6102 GPO BOX U1987, Perth WA 6845
+61892664104

Further information iconanne-marie.hill@curtin.edu.au
Australia

A pilot study to assess the feasibility of an integrated survivorship intervention to improve patient and service level outcomes for men with prostate cancer. ‘The True NTH Pilot Study’

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Trial Information

Trial summary

This study aims to implement and evaluate the feasibility of an integrated care model for prostate cancer patients that incorporates both local and centralised services. 

You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with localised  prostate cancer within the previous 3 months,  OR diagnosed with advanced prostate cancer for at least 12 months.

All patients in this study will be provided with local and centralised prostate cancer support services. These include Care Coordination, Information Provision and Decision Support, Practical Support, Peer Support, Lifestyle Plan, Speialised Support Services, and Advanced Prostate Cancer Comorbidities Management. While each component of the intervention is available for all participants, the intervention and each of its components are tailored to the patient’s stage of disease and their health related needs.  Delivery of specialised support services will depend on resource  availabililty, access, treating specialist /team  preference and preference of the patient.

Patients in this study will be asked to complete 3 surveys over a 6 month period (at the commencement of participation, followed by 3 and 6 months after the commencement of participation) in order to assess their quality of life, prostate cancer symptoms and mental health. In addition, service and carer-related outcomes will be measured. At 6 months after the commencement of participation, patients, carers and key personnel involved in delivering the intervention will be invited to complete an online survey and participate in individual interviews. 

This is a pilot study focused on determining feasiblity of a larger randomised study. If the intervention is effective, men with prostate cancer will have access to evidence based supportive care interventions that will contributed to improved health outcomes and quality of life.

Broad Health ConditionProstate cancer

Specific Health ConditionCancer
Prostate
Public Health
Health promotion/education

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD

Anticipated date of first participant enrolment7/05/2015

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Prostate cancer patients who
1)have been diagnosed with localised  prostate cancer within the previous 3 months,  OR diagnosed with advanced prostate cancer for at least 12 months 
2)are able and willing to participate in the intervention and to complete patient reported outcome assessments.
3)nominate a general practitioner who then agrees to use CDMnet.
4)are treated within Sunshine Coast Hospital and Health Service District and the Northern NSW Local Health District

Minimum age18 Years

GenderMales

Can Healthy volunteers participate?No

Key exclusion criteria

Patients will be excluded from the study if they:
1)are too unwell (as determined by treating clinician) 
2)have physical, psychological or cognitive difficulties that would prevent them from participating in the interventions or completing self report outcome measures.
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Professor Patsy Yates
Primary Sponsor Address: Institute of Health and Biomedical Innovation Queensland University of Technology 60 Musk Ave Kelvin Grove Queensland 4059
Primary Sponsor Country: Australia

Trial websitehttp://au.movember.com/programs/prostate-cancer

Trial IDACTRN12615000499583

Contact person for information and recruitmentProf
Patsy Yates
Institute of Health and Biomedical Innovation Queensland University of Technology 60 Musk Ave Kelvin Grove Queensland 4059
+61 7 31383835

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