Search results from the Australian New Zealand Clinical Trials Registry

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Keyword: "Queensland University of Technology"
Recruitment Status: Recruiting

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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

RAndomised trial aiming to imProve the quality of lIfe of people with Dementia (Alzheimer's disease) plus their carers (RAPID-Plus).

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Trial Information

Trial summary

Depression is common in people with Alzheimer’s disease (AD) and their carers and is a frequent cause of distress and reduced quality of life (QoL). Pharmacological treatment is modestly effective in treating major depression, although this is largely ineffective in those with milder depression (subsyndromal depression - SSD) and in people with dementia ,and is frequently associated with unacceptable side effects. It is therefore essential that we are able to identify safe and easily accessible therapies for these debilitating symptoms.
Cognitive bias modification (CBM) is a simple, novel and safe intervention that targets attentional and interpretative biases associated with anxiety and depression. CBM has been shown to be effective in reducing depressive symptoms in younger adults but studies in people with cognitive impairment and their carers are lacking. Our preliminary research has indicated that CBM is well tolerated by people with AD and could be easily accessed at home, making it a potentially invaluable intervention for depression in this population.
The aims of this study are to determine; The effect of CBM in reducing the severity of depressive symptoms in AD, the effect of CBM in improving mood in carers of people with AD, and the effect of CBM on QOL of people with AD and their carers. People with AD and their carers (dyads) will be randomly assigned to an active or control CBM intervention in a 2 x 2 double-blind, parallel design. The intervention will be conducted over 6 months. For AD participants and carers, change in severity of depressive symptoms, and change in QoL, after 12 weeks, will be outcomes of primary interest. For AD participants and carers, change in severity of depressive symptoms after completion of treatment at 26 weeks, and incidence of major depression at 6 months, will be secondary outcomes of interest. Burden of care as reported by carers at 12 and 26 weeks will also be a secondary outcome of interest.
Dementia is a common condition and is frequently associated with a diverse range of neuropsychiatric symptoms, including depression and anxiety. Our current understanding of the cause and management of these symptoms is far from optimal. The proposed study trials a simple and safe treatment that could be easily implemented into everyday clinical practice. This study will provide high quality evidence for the efficacy of CBM in improving the quality of lives of people with AD.

Broad Health ConditionDepression
Alzheimer's disease

Specific Health ConditionMental Health
Depression
Neurological
Alzheimer's disease

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
WA,VIC

Hospital
Royal Perth Hospital - Perth

Hospital
Bentley Health Service - Bentley

Hospital
Osborne Park Hospital - Stirling

Hospital
Fremantle Hospital and Health Service - Fremantle

Hospital
Armadale Kelmscott Memorial Hospital - Armadale

Hospital
Sir Charles Gairdner Hospital - Nedlands

Hospital
St Vincent's Private Hospital - Fitzroy

Hospital
Royal Melbourne Hospital - City campus - Parkville

Hospital
Monash Medical Centre - Clayton campus - Clayton

Anticipated date of first participant enrolment1/07/2016

Anticipated date of last participant enrolment9/02/2019

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

The inclusion criteria will be:
For AD participants
* Diagnosis of major neurocognitive disorder due to probable AD
according to DSM-5 criteria
* Mini-mental State Examination (MMSE) score of greater than or equal to 15
* Cornell Scale for Depression in Dementia (CSDD) score greater than or equal to 4
* Availability of a carer willing to participate in the trial
* Fluent in written and spoken English

For Carers, we will include those who:
* Are aged greater than or equal to 18 years
* Are fluent in written and spoken English
* Are free of diseases likely to undermine ongoing participation in the
study for 24 months (e.g., metastatic cancer)
* Do not consume alcohol in excess of 14 standard drinks per week
* Show no evidence of cognitive impairment (MMSE greater than or equal to 24/30)
* Do not meet DSM-5 criteria for major depression
* Show no evidence of active suicidal intent
* Show no evidence of visual impairment that might compromise ability to read or use the computer
* Are registered with a general practitioner

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

We will exclude individuals who:
* Meet National Institute of Mental Health criteria for depression in AD
* Have medical conditions that are likely to compromise their ability to
complete the required activities of the study e.g. severe sensory
impairment or life expectancy of < 2 years from time of enrolment
* Consume alcohol in excess of 14 standard drinks per week
* Have no health practitioner who can provide ongoing clinical care
* Decline or are unable to provide informed consent
Contact details and further information

Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: WA Centre for Health and Ageing
Primary Sponsor Address: Level 6 48 Murray St Perth, WA, 6000
Primary Sponsor Country: Australia

Trial IDACTRN12616000778482

Contact person for information and recruitmentMs
Varsha Hirani
WA Centre for Health & Ageing (M577) University of Western Australia 35 Stirling Highway Perth WA 6009 Australia
+61 8 9224 0295

Further information iconvarsha.hirani@uwa.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

Hospital
Toowoomba Hospital - Toowoomba

Hospital
Caboolture Hospital - Caboolture

Postcode
4350 - Toowoomba

Postcode
4510 - Caboolture

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

Researching Intervention in Chronic Cough in Kids Study

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Trial Information

Trial summary

ARI in  children is a leading cause of hospitalisation and preventable death and repeat episodes in infancy are associated with an increased risk of chronic lung disease. Cough in children, commonly triggered by a viral ARI is a substantial cause of morbidity and associated health and societal economic costs. Chronic wet cough in children implies increased airway secretions and lower airway infection. This novel proposal aims to determine whether a validated evidence-based cough algorithm initiated at the development of chronic cough, defined as >4 weeks duration, following an ARI improves clinical outcomes in Indigenous children compared to standard care. 

Broad Health ConditionCough
Acute respiratory infection

Specific Health ConditionRespiratory
Other respiratory disorders / diseases
Infection
Other infectious diseases

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Toowoomba Hospital - Toowoomba

Hospital
Lady Cilento Children's Hospital - South Brisbane

Hospital
Caboolture Hospital - Caboolture

Postcode
4510 - Caboolture

Postcode
4352 - Toowoomba

Postcode
4370 - Warwick

Postcode
4101 - South Brisbane

Anticipated date of first participant enrolment6/04/2015

Anticipated date of last participant enrolment31/10/2018

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Is aged 0 - < 15 years
2. Presents to participating primary health care centre with cough as a symptom
3. Parent/guardian provides written informed consent
4.. If the child is a young person aged 12 - < 15 years, written assent from that person must be obtained 

Maximum age14 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Known, doctor diagnosed, chronic lung disease (excluding asthma)

2. Known immunosuppressive condition or on long term immunosuppressant therapy (oral or inhaled steroids in the past 30 days are allowed.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Queensland University of Technology
Primary Sponsor Address: Cnr Musk and Victoria Park Rd Kelvin Grove QLD 4059
Primary Sponsor Country: Australia

Trial websiteNone to date

Trial IDACTRN12615000132549

UTNU1111-1166-0388

Contact person for information and recruitmentDr
Kerry-Ann O'Grady
Centre for Children's Health Research L7, 62 Graham Street South Brisbane, QLD 4010
+61 439 933 777

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

A Phase III randomised, controlled trial of exercise during chemotherapy for patients commencing first line treatment for ovarian cancer

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Trial Information

Trial summary

The aim of this study is to determine the enduring effects on survivorship of an exercise intervention administered in addition to usual care, compared to usual care alone, during first-line chemotherapy for epithelial ovarian, primary peritoneal and fallopian tube cancer. Who is it for? You may be eligible to join this study if you are a woman aged 18 years or above and have been newly diagnosed with epithelial ovarian, primary peritoneal or fallopian tube cancer of any histological type and are suitable for first-line chemotherapy. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive a structured exercise program, in addition to usual care, whilst participants in the other group will receive usual care alone. The structured exercise program will likely include walking and resistance exercise. Participants will be asked to complete questionnaires regarding their physical well-being and quality of life. Participants will be followed for up to 5 years, in order to determine survival rates. 

Broad Health ConditionOvarian Cancer

Specific Health ConditionCancer
Ovarian and primary peritoneal

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Royal Brisbane & Womens Hospital - Herston

Hospital
Mater Adult Hospital - South Brisbane

Hospital
The Canberra Hospital - Garran

Hospital
The Chris O’Brien Lifehouse - Camperdown

Hospital
Campbelltown Hospital - Campbelltown

Hospital
Westmead Hospital - Westmead

Hospital
Greenslopes Private Hospital - Greenslopes

Hospital
Mater Private Hospital - South Brisbane

Postcode
4006 - Herston

Postcode
4101 - South Brisbane

Postcode
2605 - Garran

Postcode
2050 - Camperdown

Postcode
2560 - Campbelltown

Postcode
2145 - Westmead

Postcode
4120 - Greenslopes

Postcode
4101 - South Brisbane

Anticipated date of first participant enrolment5/01/2015

Anticipated date of last participant enrolment15/12/2017

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Women with newly diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer of any histological type, suitable for first-line chemotherapy
2.	Age > or = 18 years
3.	ECOG status 0-2
4.	Willing and able to comply with all study requirements, including the exercise intervention, timing and/or nature of required assessments
5.	Sufficiently fluent in English to fully participate in data collection requirements and comprehend intervention requirements 
6.	Scheduled for chemotherapy or has commenced chemotherapy. Participants must be enrolled prior to commencement of the 2nd cycle of chemotherapy 
7.	Signed written informed consent 

Minimum age18 Years

GenderFemales

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Women with diagnosis of recurrent ovarian cancer
2.	History of another malignancy within 3 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, Stage I melanoma in situ or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease-free for at least 3 years after definitive primary treatment.
3.	Concurrent illness, including severe infection or unstable angina that may jeopardise the ability of the patient to undergo the exercise intervention outlined in this protocol with reasonable safety.
4.	Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: University of Sydney
Primary Sponsor Address: NHMRC Clinical Trials Centre Locked Bag 77 Camperdown NSW 1450
Primary Sponsor Country: Australia

Trial websiteN/A

Trial IDACTRN12614001311640

Contact person for information and recruitmentA/Prof
Sandi Hayes
Queensland University of Technology Victoria Park Road, Kelvin Grove QLD 4059
+617 3138 9645

Further information iconsc.hayes@qut.edu.au
Australia

Tooth and Lung Sickness in Murri Medical Kids

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Trial Information

Trial summary

Despite the burden of acute respiratory illnesses (ARI) among  children being a substantial cause of childhood morbidity and associated costs to families, communities and the health system, data on disease burden in urban children are lacking. Consequently evidence-based decision-making, data management guidelines, health resourcing for primary health care services and prevention strategies are lacking. This study aims to comprehensively describe the epidemiology, impact and outcomes of ARI in urban  children  in the greater Brisbane area. 

Broad Health ConditionRespiratory Health
Oral Health

Specific Health ConditionRespiratory
Other respiratory disorders / diseases
Oral and Gastrointestinal
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health
Epidemiology

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Postcode
4510 - Caboolture

Anticipated date of first participant enrolment14/02/2013

Anticipated date of last participant enrolment30/11/2015

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Aged less than 5 years
Registered with Murri Medical Health Services
Not moving from study area in next 12 months

Maximum age59 Months

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

None
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: The Lady Cilento Children's Hospital
Primary Sponsor Address: 53 Raymond Terrace South Brisbane, Queensland 4101
Primary Sponsor Country: Australia

Trial websiteNone

Trial IDACTRN12614001214628

UTNNil

Contact person for information and recruitmentMrs
Kerry Hall
Level 7, Centre for Children's Health Research, 62 Graham Street South Brisbane Queensland 4101
61 7 0424359347

Further information iconkk.hall@qut.edu.au
Australia

The OPTIONS study. Evaluating a patients' decision tool (OPTIONS tool) for considering treatment choices for the elderly with end stage kidney disease.

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Trial Information

Trial summary

The aim of the study is to examine the effectiveness of an evidence based decision making intervention (OPTIONS tool) for older people considering treatment options for end stage kidney disease. The anticipated study outcome will be reduced decisional conflict and uncertainty, improved knowledge regarding benefits and harms of dialysis and lower decisional regret.

Broad Health ConditionChronic Kidney Disease

Specific Health ConditionRenal and Urogenital
Kidney disease

Trial FocusEducational / counselling / training

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Hervey Bay Hospital - Pialba

Hospital
Maryborough Hospital - Maryborough

Hospital
Royal Brisbane & Womens Hospital - Herston

Hospital
Nambour General Hospital - Nambour

Hospital
Toowoomba Hospital - Toowoomba

Postcode
4655 - Hervey Bay

Postcode
4650 - Maryborough

Postcode
4000 - Brisbane

Postcode
4560 - Nambour

Postcode
4350 - Toowoomba

Anticipated date of first participant enrolment3/11/2014

Anticipated date of last participant enrolment31/12/2016

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Age equal to/greater than 70 years of age
Glomerular Filtration rate - equal to/less than 20 mL/min
No prior decision made regarding treatment options

Minimum age70 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Non english speaking
Declared medically incompetent
Eligible for kidney transplant
Contact details and further information

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

Trial IDACTRN12614001090606

UTNU1111-1160-9388

Contact person for information and recruitmentMs
Leanne Brown
Renal Unit Hervey Bay Hospital PO Box592 Pialba. 4655. Qld
+61 448143303
+61 7 43256787
Further information icondbro5759@bigpond.net.au
Australia

Stand Up for Health Project: Using a ‘whole room calorimeter’ to assess the effects of sitting on adolescents health

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Trial Information

Trial summary

The aim of the study is to assess how reducing adolescent sitting time affects adolescents’ energy levels, cardio-metabolic measures and their level of concentration. To accurately assess these outcomes, the study involves the use of the whole room calorimeter. The whole room calorimeter is a room around the size of an adolescent’s bedroom that measures the oxygen consumption and carbon dioxide production of the person inside. These measurements enable energy levels to be accurately measured.
Research shows that adolescents spend more than 50% of their waking hours sitting. The total period of time they sit for per day is only slightly less than the total time the elderly (65 years and older) sit. Research involving adolescent sitting- time and health outcomes is limited. It has been reported that high levels of sitting are associated with lower levels of cardiorespiratory fitness, and higher levels of cholesterol, and body fat. Given the potential harmful effects of excessive sitting and that a large majority of an adolescent’s waking day is spent at school, it is important to understand how much more energy is expended if an adolescent sits for less total time during a typical school day. Currently adolescents spend approximately 240 minutes (4 hours) each day sitting during school time.
This study plans to investigate a reduction in sitting time amongst adolescents during a typical day at school. It has the potential to improve the energy expenditure, which can impact health and developmental outcomes of adolescents. This study will provide the highest level of evidence available to move this research field forward, due to use of the University of Wollongong’s whole- room calorimeter, as it is the only one in Australia.

Broad Health ConditionOverweight and obesity
Cardio-metabolic health indicators
Sitting time
Cognition

Specific Health ConditionCardiovascular
Normal development and function of the cardiovascular system
Public Health
Health promotion/education
Diet and Nutrition
Obesity

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Anticipated date of first participant enrolment6/06/2014

Anticipated date of last participant enrolment25/10/2014

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Minimum age 12, maximum age 15- healthy participants

Minimum age12 Years

Maximum age15 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

Participant is claustrophobic
Participant has a medical condition or illness that will influence the outcome of energy expenditure or cardio-metabolic indicators
Participant is not in the age range 12-15 years
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: University of Wollongong
Primary Sponsor Address: University of Wollongong Wollongong NSW 2522
Primary Sponsor Country: Australia

Trial websitehttp://ieri.uow.edu.au/standupforhealth/index.html

Trial IDACTRN12614001064695

UTNU1111-1160-5321

Contact person for information and recruitmentDr
Anne-Maree Parrish
Dr Anne-Maree Parrish School of Health and Society Faculty of Social Sciences University of Wollongong NSW 2522
+61 2 4221 5098
+ 61 2 4221 5945
Further information iconaparrish@uow.edu.au
Australia

Pilot study to evaluate the prognostic and metabolic effects of metformin during treatment of metastatic prostate cancer with androgen deprivation therapy

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Trial Information

Trial summary

This study will investigate the effects of combining metformin with androgen deprivation therapy (ADT) in men with metastatic prostate cancer.

You may be eligible to join this study if you are male, aged 18 years or above and have been diagnosed with metastatic prostate adenocarcinoma, for which you have not received any ADT.

Study details
Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will take 3 x 500mg oral tablets of metformin hydrochloride daily for 30 weeks, whilst participants in the other group will take 3 oral tablets of placebo (inactive treatment) daily for 30 weeks. 
Participants will be followed-up every 6 weeks for 54 weeks, in order to determine metabolic and tumour responses and tumour progression.

Broad Health ConditionMetastatic prostate cancer

Specific Health ConditionCancer
Prostate

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD,VIC

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Epworth Richmond - Richmond

Hospital
Gold Coast Hospital - Southport

Postcode
4102 - Woolloongabba

Postcode
3121 - Richmond

Anticipated date of first participant enrolment8/09/2014

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Age above 18 years
2.	Competent to understand information and provide written informed consent
3.	Metastatic prostate adenocarcinoma defined by radiological diagnosis (TNM staging), PSA greater or than equal to 20 in the presence of tissue diagnosis or abnormal prostate examination, PSA recurrence post surgery or radiotherapy
4.	No prior chemotherapy for prostate cancer
5.	Not on insulin control medications [Insulin, oral hypoglycaemic agents, systemic corticosteroid of any dosage, atypical antipsychotic drugs of any dose]
6.	Adequate renal function (Creatinine equal to 177mmol/L, GFR greater than 30 mls/min)
7.	Adequate hepatic function (Bilirubin must be equal to 1.5 x upper limit of normal range, ALT and ALP must be equal to 2.5 x upper limit of normal) 
8.	Life expectancy greater than 6 months

Minimum age18 Years

GenderMales

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Known brain metastasis
2.	Malignant disease other than prostate cancer at the time of enrolment, apart from completely treated non-melanomatous skin malignancy
3.	Prior chemotherapy for prostate cancer
4.	Prior primary radiotherapy within 6 weeks
5.	Previously treated with ketoconazole for greater than 7 days
6.	Prior systemic treatment with an azole drug within 4 weeks
7.	Prior antiandrogen treatment within 6 weeks
8.	History of lactic acidosis 
9.	History of pituitary or adrenal dysfunction
10.	Cardiac (heart failure NYHA class II or greater, acute myocardial infarct, unstable angina, arterial-thromboembolic event within past 6 months) or respiratory insufficiency (active pulmonary embolism, severe chronic obstructive pulmondary disease), severe liver failure (cirrhosis with a Child-Pugh level of B or greater), severe infection that is likely to increase the risk of lactic acidosis 
11.	Medical or psychiatric conditions that compromise the patient's ability to give informed consent
12.	History of pituitary or adrenal dysfunction
13.	Participants will be discharged from the study if unable to tolerate metformin due to adverse reactions or develop medical conditions such as renal failure or diabetes requiring additional agents other than metformin
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, Australia
Primary Sponsor Country: Australia

Trial IDACTRN12614001054606

Contact person for information and recruitmentProf
Colleen Nelson
Australian Prostate Cancer Research Centre – Queensland Level 1, Building 1, Princess Alexandra Hospital, 199 Ipswich Road, Brisbane QLD 4102
+61 7 3176 7443

Further information iconcolleen.nelson@qut.edu.au
Australia

Effect of sunlight exposure on vitamin D status: A pilot randomized controlled trial

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Trial Information

Trial summary

Vitamin D is essential for human well-being. Skin conversion of 7-dehydrocholesterol to previtamin D3 by UVB radiation from sun exposure remain the most abundant source of vitamin D for most humans. Available evidence suggests that relatively high proportions of people in many different countries, including in Australia and New Zealand, have low vitamin D status. However exposure to the sun causes skin cancer and it is therefore critical to develop a better understanding about possible balance between the risks and benefits of sun exposure. In particular, it is important to know how much sun exposure is needed to optimize vitamin D in different groups of people.
The aim of the study is to measure the magnitude of effect of natural sun exposure three days a week for three weeks on the vitamin D level of fair-skinned indoor workers. 
This study will be a two-arm randomized controlled trial. Fair-skinned indoor workers aged 18 to 60 years will be randomized into two groups – control and intervention. Participants in the intervention group will be exposed to natural sunlight three days a week for three weeks while those in the control group will go about their business as usual. Blood samples will be collected from the participants pre- and post-intervention to study their levels of vitamin D. A follow up blood sample will be collected from all participants four weeks after the intervention to determine any wash-out effect. The participants’ incidental sun exposure will be monitored through UV monitors. Questionnaires will be administered to gather demographic, sun exposure and sun protection behavior as well as outdoor activity in the weekends during the intervention period.
It is anticipated that this study will offer us a better understanding about the extent of effect sunlight has on vitamin D levels of people with fair skin.

Broad Health Conditionvitamin D insufficiency/deficiency

Specific Health ConditionPublic Health
Epidemiology

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Anticipated date of first participant enrolment6/08/2014

Anticipated date of last participant enrolment12/09/2014

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Adults aged 18-60 yrs
2. Fair-skinned (Fitzpatrick skin type II-III)
3. Indoor workers (at least 80% FTE)
4. Residing in Brisbane for the duration of the study

Minimum age18 Years

Maximum age60 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

1. Spending more than 15 mins/day in the sun between 8 am and 4 pm
2. History of excision of keratinocytic lesions (in the last 5 years) 
3. Any past history of melanoma
4. Skin photosensitivity disorder
5. Bleeding disorder (for example, haemophilia)
6. Taking vitamin D supplements and unwilling to stop taking them
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Queensland University of Technology
Primary Sponsor Address: Cnr Musk and Victoria Park Rd Kelvin Grove QLD 4059 GPO Box 2434 Brisbane, QLD 4001
Primary Sponsor Country: Australia

Trial IDACTRN12614000863639

Contact person for information and recruitmentProf
Michael Kimlin
Institute of Health and Biomedical Innovation Queensland University of Technology, 60 Musk Ave, Kelvin Grove, QLD 4059, Australia
+61731385802
+61731386030
Further information iconm.kimlin@qut.edu.au
Australia

Evaluation of Multiparametric Magnetic Resonance Imaging and Positron Emission Tomography with a [68Ga]gallium-labelled prostate-specific membrane antigen (PSMA) ligand for the Detection of Multiple Cancer Foci in Localized Prostate Cancer Patients – A Pilot Study

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Trial Information

Trial summary

The study aims to evaluate the applicability of Multiparametric Magnetic Resonance Imaging (MP MRI) and Positron Emission Tomography (PET) with [68Ga]Gallium-labelled prostate-specific membrane antigen (PSMA) ligand  (68Ga-HBED-CC) for the detection of cancer foci in localised prostate cancer patients. 

You may be eligible to join this study if you are a male aged 18 years or above who has been diagnosed with localised prostate cancer, and are awaiting prostatectomy. 

All participants in this study will undergo Multiparametric (MP) Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) with [68Ga]Gallium-labelled Prostate-specific membrane antigen ligand (68Ga-HBED-CC) and whole-mount pathology analysis. 

For MP MRI the participants will be lying flat on the back on a bed that moves through a scanner. In order to get the best pictures, the participants will be injected with a contrast agent (or “dye”). The whole scan would take about 30 to 40 minutes. A medication called Buscopan or Glucagon is injected into the blood stream to slow bowel movement, since a moving bowel can reduce the quality of the image. 

For PET, the [68Ga]Gallium-labelled Prostate-specific membrane antigen (PSMA) ligand will be injected into the blood stream. After 90 minutes, the participants will be placed in the PET scanner and the scan will begin (scanning takes ~30 minutes). A low dose whole-body computed tomography (CT) scan will be performed during the PET scan as this helps to interpret the PET scan.

For whole-mount pathology, the participants do not need to do anything. The prostate tissue will be collected after surgery as part of their clinical management. A standard pathology report will be reported to the surgeon as a standard clinical management.  

Results will be compared and analysed once we have the results from PET scan, multiparametric MRI scan and wholemount pathology review.

Broad Health ConditionLocalized Prostate Cancer

Specific Health ConditionCancer
Prostate

Trial FocusDiagnosis

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Anticipated date of first participant enrolment1/08/2014

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.Male patients pathologically diagnosed with localized prostate cancer, awaiting prostatectomy
2. The time interval between last prostate biopsy and planned MP-MRI or planned 68Ga- HBED-CC PET must be not less than 8 weeks
3. No known problems with peripheral intravenous or central line access
4. Able to provide informed signed consent

Minimum age18 Years

GenderMales

Can Healthy volunteers participate?No

Key exclusion criteria

1. Age under 18 years
2. Prior pelvic external beam radiation therapy or brachytherapy, prior chemotherapy, prior hormonal or radiation therapy for prostate cancer
3. Administered a radioisotope within 5 physical half-lives prior to study enrolment
4. Treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
5. Hemorrhagic cystitis or active prostatitis
6. Unable to lie flat during or unable to tolerate MP MRI or PET
7. Prior history of any other malignancy within last 2 years
8. Contraindication to MRI or MRI contrast agent or PET scan or [68Ga]gallium-labelled PSMA ligand 
9. Claustrophobia not manageable by oral sedatives ie Temazepam
10. Moderate to severe rectal inflammation
11. Previous rectal surgery that will affect prostate imaging 
12. MRI incompatible pacemakers
13. Metallic implants or pumps which are MRI incompatible
14. Renal impairment or hemodialysis.
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, Australia
Primary Sponsor Country: Australia

Trial IDACTRN12614000783628

UTNNil

Contact person for information and recruitmentDr
Peter Heathcote
Dr Peter Heathcote Brisbane Urology Clinic Level 11, BMM Place, 135 Wickham Terrace, Brisbane, QLD 4000
+61 7 38303310 (for Brisbane, Australia)
+61 7 38303399
Further information iconheathcote@birsbaneurologyclinic.com.au
Australia

Improving glucose monitoring with lifestyle intervention for individuals with impaired glucose tolerance

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Trial Information

Trial summary

This study aims to establish the validity and precision of continuous glucose monitors (CGM's) for determining glycemia in response to diet and exercise. CGM's are a new, minimally invasive technology that provide greater insight into the direction, magnitude and frequency of daily glucose fluctuations. Postprandial glycemia is a significant determinant of glycemic control in individuals with impaired glucose tolerance. Given the prevalence of diabetes, it is important to identify effective lifestyle interventions to treat and manage pre-diabetes, and quantify the capacity to monitor daily variations in glucose control. We hypothesise that CGM precision will be reduced during high glucose excursions and strenuous exercise, and that high intensity exercise will be superior for promoting the return of glycemia to basal levels.

Broad Health ConditionImpaired glucose tolerance

Specific Health ConditionMetabolic and Endocrine
Diabetes

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Postcode
4059 - Kelvin Grove

Anticipated date of first participant enrolment1/09/2014

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Fasting plasma glucose value between 5.6-6.9 mmol/L
HbA1c value between 5.7-6.4%
Physically inactive (< 30 minutes of physical activity per week)
Body mass index < 29.9 kg/m2 

Minimum age20 Years

Maximum age55 Years

GenderMales

Can Healthy volunteers participate?No

Key exclusion criteria

Obesity (BMI > 30kg/m2)
Uncontrolled hypertension (> 160 mmHg systolic and/or > 100 mmHg diastolic)
History of cardiovascular disease
Liver disease
Contraindications to exercise training 

Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Stephanie Zietek
Primary Sponsor Address: Queensland University of Technology (QUT) Institute of Health and Biomedical Innovation (IHBI) 60 Musk Ave Kelvin Grove, QLD 4059
Primary Sponsor Country: Australia

Trial IDACTRN12614000742673

UTNU1111-1157-5167

Contact person for information and recruitmentMiss
Stephanie Zietek
Institute of Health and Biomedical Innovation (IHBI) 60 Musk Ave Kelvin Grove, QLD 4059
+61 7 3138 6095

Further information icons.zietek@qut.edu.au
Australia

The effect of modified night lighting on sleep characteristics, and activity levels among admitted inpatients.

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Trial Information

Trial summary

This study will explore the influence of modified night lighting installed in specific locations within hospital patient rooms and toilets,  on how well patients sleep, how they move about at night and the effect of the lighting on other related aspects of the environment (such as the use of other forms of lighting at night). 

The modified lighting is being implemented as part of a  larger study, a cluster randomised controlled trial across six RBWH wards, examining whether improved night lighting reduces the number of patient falls on these wards. 

By collecting this additional data directly from patients before and after the lighting is installed, the current observational study will allow us to compare whether there are differences at the patient-level between control and intervention environments.

Broad Health ConditionInpatient sleep and activity levels

Specific Health ConditionPublic Health
Health service research
Other
Research that is not of generic health relevance and not applicable to specific health categories listed above

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Royal Brisbane & Womens Hospital - Herston

Postcode
4029 - Royal Brisbane Hospital

Anticipated date of first participant enrolment11/06/2014

Anticipated date of last participant enrolment30/09/2015

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Patients admitted to one of six RBWH wards recruited to a larger cluster randomised controlled trial  (registration ID: ACTRN12614000615684) studying the effect of modified night lighting on inpatient falls.

Minimum age65 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

We will exclude patients who have been in the ward for longer than 30 days or are due to be discharged within the following 3 days. 

We will also exclude patients that have provided data for the current study in a previous month (on any wards). 

Patients with known cognitive impairment will be excluded, as an important element of this observational study is to capture data on participant subjective experience of the sleep environment, on sleep quality and on disruptions.  Self-report data of this nature could be unreliable in cognitively impaired populations. 

Due to lack of multi-language versions of the scales used in this study, we will also exclude patients who are not fluent in English. 

Lastly, we will exclude patients who are unstable or too unwell to participate. 

Patient eligibility will be established by the study research officer (SRO) in consultation with the ward nurse manager or shift coordinator at each recruitment point (a calendar month).
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Royal Brisbane and Women's Hospital
Primary Sponsor Address: Royal Brisbane and Women's Hospital Cnr of Butterfield Street and Bowen Bridge Road Herston Queensland 4029
Primary Sponsor Country: Australia

Trial websiteTBA

Trial IDACTRN12614000616673

UTNU1111-1157-8275

Contact person for information and recruitmentMr
Satyan Chari
Safety and Quality Unit Level 7 Block 7 Royal Brisbane and Women's Hospital Metro North Hospital and Health Service Herston Queensland 4029
61 7 3646 5375
61 7 3646 1406
Further information iconsatyan.chari@health.qld.gov.au
Australia

A night-lighting intervention to reduce inpatient falls: A stepped-wedge cluster randomised controlled trial

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Trial Information

Trial summary

BACKGROUND

Falls among older hospital patients are a concerning and costly problem. While most falls occur during the day, nearly 40% happen outside normal hours; potentially while patients attempt to mobilise to and from the toilet in poorly lit environments.  A practical solution for these problems is the installation of targeted low-intensity lighting around key room features without disrupting the dark sleep environment. Previous laboratory research has demonstrated improved postural stability and gait among older people with such lighting. Subsequent evaluations in aged care facilities have confirmed high levels of acceptance among staff and residents.  

In order to test the clinical acceptability of this solution the investigative team recently completed a multi-site user acceptance study (unpublished). Formal patient and staff feedback after ward demonstrations of the novel lighting confirmed both acceptability and the likelihood of sleep and safety improvements. User feedback has been incorporated into the final intervention design for the present trial.

AIM

We aim to test the effect of the night lighting intervention on ward level patient fall rates. 

METHODS
 
The effect of our intervention on the primary outcome will be evaluated through a stepped-wedge cluster randomised controlled trial (RCT) across six inpatient wards at the Royal Brisbane and Women's Hospital over fourteen months. A stepped-wedge cluster RCT design describes a staggered roll-out of the intervention across participating wards such that the order of roll-out is randomly generated. Therefore, participating wards provide control data prior to implementation and intervention data after implementation.  
 

Broad Health ConditionAccidental Falls

Specific Health ConditionPhysical Medicine / Rehabilitation
Other physical medicine / rehabilitation
Injuries and Accidents
Other injuries and accidents
Public Health
Health service research

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Postcode
4029 - Royal Brisbane Hospital

Anticipated date of first participant enrolment11/06/2014

Anticipated date of last participant enrolment3/09/2014

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

All patients admitted in study wards during the 14 month trial period will be included.

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Nil patient level exclusion criteria will apply. 

As the unit of recruitment for the cluster RCT is a hospital ward, data pertaining to all patients admitted to trial wards will be included in analysis.

Exclusion criteria applies to ward selection. All on-campus Royal Brisbane and Women's Hospital wards were placed on a list in descending order based on reported rates of falls over the preceding two years. Wards that were planned for refurbishment during the trial period were excluded. The top six remaining wards were approached for inclusion in this study.

Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Royal Brisbane and Women's Hospital, Queensland Health, Australia
Primary Sponsor Address: Royal Brisbane and Women’s Hospital Cnr Butterfield St and Bowen Bridge Rd Herston Queensland 4029
Primary Sponsor Country: Australia

Trial IDACTRN12614000615684

UTNU1111-1157-6331

Contact person for information and recruitmentMr
Satyan Chari
Safety and Quality Unit Level 7 Block 7 Royal Brisbane and Women's Hospital Metro North Hospital and Health Service Herston Queensland 4029
+61 7 3646 5375
+61 7 3646 1406
Further information iconsatyan.chari@health.qld.gov.au
Australia

A person-centred model of residential respite care transition support: The Transition Support-Person Centred Care (TS-PCC) Program for family caregivers and care recipients with dementia

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Trial Information

Trial summary

The research design to be employed is a cluster randomized controlled trial of a multi-component intervention designed to improve the experience of Residential Respite Care (RRC) for people with dementia and their carers. Clustering will occur at the facility level with randomisation by necessity occurring at this level in order to prevent contamination of results due to changed processes during RRC admission required by the intervention. Thus, two facilities will be allocated as the intervention facilities and two as control facilities. Random allocation will occur via a random number generator.
The program will provide support and communication before, during and after residential respite admission in order to facilitate the transition to respite care.
Participants with dementia (PWD) and their carers will be interviewed face – to –face and also complete self –report instruments 2 weeks prior to moving into RRC.
Allocation of residents will occur to either intervention or control group and all will be assessed during RRC admission.
PWD and their carers will be interviewed face to face and asked to complete self report measures when transiting back to home care.
PWD and their carers will be interviewed via telephone and asked to complete self report measures three months following return to home care.

Broad Health ConditionDementia

Specific Health ConditionNeurological
Dementias
Public Health
Health service research

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Postcode
4017 - Sandgate

Anticipated date of first participant enrolment1/09/2013

Anticipated date of last participant enrolment30/06/2014

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Group 1: Intervention group (n=10) -   65 years and older, with a diagnosis of dementia, with a confirmed booking for residential respite
Group 2: Control group (n=10) - 65 years and older, with a diagnosis of dementia, with a confirmed booking for residential respite
Group 3: Family caregiver intervention group (n=10): care giver of person with dementia, aged over 18 years, directly responsible for the care of participating person with dementia, have known person with dementia for more than 10 years, have 3 contacts per week with person with dementia
Group 4: Family caregiver control group (n=10): care giver of person with dementia, aged over 18 years, directly responsible for the care of participating person with dementia, have known person with dementia for more than 10 years, have 3 contacts per week with person with dementia
Group 5: Liaison Nurse (n=2): Registered, enrolled or endorsed enrolled nurses working at the intervention facilities, 21 years and older

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

Carers under the age of 18 years, no diagnosis of dementia, no residential respite booking
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 IDACTRN12614000043639

UTNU1111-1151-7620

Contact person for information and recruitmentDr
Maria O'Reilly
School of Nursing, Queensland University of Technology Victoria Park Road, Kelvin Grove, 4059 Qld.
+61 7 31383057
+61 7 31385941
Further information iconm2.oreilly@qut.edu.au
Australia

Hospital to home outreach for malnourished elders (HHOME): can better nutrition planning and follow-up improve nutrition and function in older medical patients?

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Trial Information

Trial summary

Many older patients admitted to hospital for acute medical illnesses are undernourished, which increases the number and length of hospital admissions. Unfortunately, treating malnutrition during a short hospital admission only produces modest improvements, so we are interested in redesigning the delivery of hospital nutrition care to continue into the post-discharge period to see if this can increase the benefits to patients. 
With the “Hospital to Home Outreach for Malnourished Elders” (HHOME) program, patients will receive individualised planning of nutrition needs after hospital discharge by their inpatient multidisciplinary team, supported by phone follow-up from their hospital dietitian to reinforce nutritional advice, co-ordinate community-based nutrition services and re-intervene after care would traditionally cease. The program also includes greater education of health care staff involved in the care of older patients, as well as patients and carers. 
By comparing patients cared for with usual hospital-only dietetics care, and those under the new HHOME program, we hope to measure an improvement in patient outcomes including nutritional and functional status. We will also measure hospital use, quality of life and costs of the new model of care, to inform whether these improvements might benefit the health system by saving future use of health services. 

Broad Health ConditionMalnutrition

Specific Health ConditionDiet and Nutrition
Other diet and nutrition disorders
Public Health
Health service research

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Royal Brisbane & Womens Hospital - Herston

Hospital
The Prince Charles Hospital - Chermside

Postcode
4029 - Royal Brisbane Hospital

Postcode
4032 - Chermside

Anticipated date of first participant enrolment3/09/2012

Anticipated date of last participant enrolment10/05/2013

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Age 65 and older
Discharged from general medical units at Royal Brisbane or Prince Charles hospitals
Malnutrition screening tool (MST) score 2 or greater and/or body mass index <18.5
Consent to inclusion

Minimum age65 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Discharged to residential aged care or inpatient rehabilitation facility
Life expectancy <6 months
Lives outside of district
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Royal Brisbane and Women's Hospital
Primary Sponsor Address: Department of Internal Medicine and Aged Care Royal Brisbane and Womens' Hospital Butterfield St Herston Queensland 4029
Primary Sponsor Country: Australia

Trial IDACTRN12613000760774

UTNU1111-1136-7302

Contact person for information and recruitmentDr
Adrienne Young
Department of Nutrition and Dietetics 2nd floor, James Mayne Building Royal Brisbane and Women's Hospital Butterfield St Herston Qld 4029
61 7 36467997

Further information iconAdrienne_Young@health.qld.gov.au
Australia