Search results from the Australian New Zealand Clinical Trials Registry

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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

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

The effects of prolonged wear of textured shoe insoles on walking in people with Multiple Sclerosis

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Trial Information

Trial summary

Many people with Multiple Sclerosis (MS) experience problems with walking, which can make day to day activities difficult and often leads to falls. Improving walking ability is, therefore, of primary importance in maintaining health, independence, and quality of life in people living with MS. Walking problems in MS are often caused by a combination of typical symptoms, such as altered function of muscles, nerves, and senses. The key to improving mobility is, therefore, to use a range of different treatment techniques which address each of these symptoms. Foot sensation plays an important role in keeping the body upright and balanced whilst walking, yet, we know from previous studies that people with MS often have poor sensation on the soles of their feet. It is, therefore, possible that wearing a specially designed shoe insole, which enhances sensory information at the feet, could help people affected by MS to walk better. This would offer health care professionals a new, additional treatment technique to help manage walking problems in MS. This study will explore whether long-term wear of a textured shoe insole can improve walking in people with MS. We will analyse how people with MS walk over an even and uneven surface, when they are wearing the insoles for the first time, and after wearing the insoles for three months. We will explore whether wearing the insoles changes the way the body moves, or the leg and trunk muscles work during walking. We will also monitor any changes in the perception of foot sensation and the awareness of foot position, to help us better understand how our insoles may bring about their effects on walking. The benefit for people affected by MS is that this study could lead to the development of a new treatment technique, specifically an inexpensive, easy-to-administer shoe insole, which could help towards improving mobility and independent living.  

Broad Health ConditionMultiple Sclerosis
Walking Impairment
Falls Risk

Specific Health ConditionNeurological
Multiple sclerosis
Physical Medicine / Rehabilitation
Other physical medicine / rehabilitation

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Anticipated date of first participant enrolment25/05/2015

Anticipated date of last participant enrolment31/12/2017

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Men and women aged >18 years, with a clinical diagnosis of Multiple Sclerosis; Disease Steps grading 1-4; and ambulant over 100 metres with or without the use of an assistive device (cane/crutch).

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Neurological conditions other than Multiple Sclerosis;
Peripheral neuropathy to a degree that would preclude the ability to perceive the textured insole;
Currently being prescribed over-the-counter or custom-made foot orthoses;
Cardiovascular or orthopaedic conditions including recent injury to the back or legs limiting ambulation; 
Unstable psychiatric condition; 
Cognitive impairment.

Participants who report a formal exacerbation of Multiple Sclerosis symptoms persisting >24hrs, four weeks prior to, or at any time during, the intervention period will be excluded from the study.
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Dr Anna Hatton
Primary Sponsor Address: School of Health and Rehabilitation Sciences, Therapies Building (84A), The University of Queensland, St Lucia, QLD 4072
Primary Sponsor Country: Australia

Trial IDACTRN12615000421538

Contact person for information and recruitmentDr
Dr Anna Hatton
School of Health and Rehabilitation Sciences, Therapies Building (84A), The University of Queensland, St Lucia, Brisbane, QLD 4072
+61733654590

Further information icona.hatton1@uq.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

The effects of aerobic- versus resistance-based exercise on breast cancer-related lymphoedema

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Trial Information

Trial summary

The study is evaluating and comparing the effects of aerobic-based versus resistance-based exercise to usual care on lymphoedema, lymphoedema-related symptoms (e.g. decreased fitness, impaired functioning, changes in weight, strength loss), and quality of life.

Who is it for?
You may be eligible to join this study if you are a female, aged 18 years to 70 years, with a diagnosis of unilateral breast cancer-related lymphoedema following nonmetastatic breast cancer, completed all cancer-related treatments, and physically capable of participating in a moderate-intensity exercise program.

Trial details
Participants in this study will be randomly (by chance) divided into one of three groups. Participants in one group will be allocated to a 12 week aerobic-based exercise intervention. Participants in the second group will be allocated to a 12-week resistance-based exercise intervention.  Participants in the third group will be allocated to usual care, which will involves a weekly phone call to monitor physical activity levels and lymphoedema symptoms and treatment, as well as to maintain study interest. Following the 24-week intervention, this group will be offered a personalised exercise program.  All participants, regardless of group allocation, will be assessed pre- and post-intervention and again at 12 weeks post-intervention.

Participants will be required to complete some questionnaires and tests throughout the duration of the trial in order to evaluate the effects of aerobic-based exercise and resistance-based exercise on fitness level, weight changes, strength, function, self-efficacy, presence of lymphoedema and quality of life. The results of this trial will help gain a better understanding on whether participating in certain exercise types provides greater lymphoedema-related benefits over other types or usual care.

Broad Health ConditionBreast cancer-related lymphoedema

Specific Health ConditionCancer
Breast
Physical Medicine / Rehabilitation
Other physical medicine / rehabilitation

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Princess Alexandra Hospital - Woolloongabba

Anticipated date of first participant enrolment20/05/2013

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Women with a diagnosis of unilateral breast cancer-related lymphoedema following nonmetastatic breast cancer, completed all cancer-related treatments, physically capable of participating in a moderate-intensity exercise program

Minimum age18 Years

Maximum age70 Years

GenderFemales

Can Healthy volunteers participate?No

Key exclusion criteria

unable to read and understand English; pregnant or may become pregnant during intervention; ECOG status of 3+; women with a cognitive impairment or mental illness; currently undertaking more than half of the exercise prescription (i.e. 75 minutes/week of moderate-intensity exercise)
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Jena Buchan
Primary Sponsor Address: School of Public Health and Social Work O Block, A wing QUT, Kelvin Grove Campus GPO Box 2434 Brisbane QLD 4001
Primary Sponsor Country: Australia

Trial IDACTRN12613000665730

UTNU1111-1144-1562

Contact person for information and recruitmentMs
Jena Buchan
School of Public Health and Social Work O Block, A wing QUT, Kelvin Grove Campus GPO Box 2434 Brisbane QLD 4001
+61731385677

Further information iconjena.buchan@qut.edu.au
Australia

The Watermemories Swimming Club for People with Dementia

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Trial Information

Trial summary

We are implementing the WSC for residential aged care adults with dementia in the Brisbane and Toowoomba area. This project aims to rekindle positive memories of swimming in people with dementia and get them involved in a safe, regular physical activity. Swimming is an activity that has the capacity to address physical health needs, because it involves exercise; psychological health needs, because it is fun and relaxing; and social health needs, because it involves interactions with other people. Further, we aim to investigate whether participation in an evidence-based aquatic exercise program leads to changes in adults’ quality of life for adults with dementia living in residential aged care facilities, in terms of behavioural and psychological symptoms, depression and physical health. In our pilot study, conducted in Toowoomba in 2011, we showed that the WSC has the potential to positively influence sleep, appetite, pain, falls resistance, behavioural and psychological symptoms of dementia, depression, physical strength and flexibility and social functioning. The results of the pilot study showed that the WSC intervention improved left hand grip and psychological well-being, decreased the number of behavioural and psychological symptoms of dementia expressed and decreased the extent to which these behaviours distressed staff. In our current research project, we are predicting that there will be greater improvements to the quality of life of adults participating in the WSC, compared to adults receiving usual care. (For information about the pilot study, please see the following publications: (1) Neville, C., et al. (2013). "Watermemories: a swimming club for adults with dementia." Journal of gerontological nursing 39(2): 21-25; (2) Henwood, T., et al. (2012). "The Watermemories Swim Club for people with dementia." Australasian Journal on Ageing. 31(S2): 13, 23-24, 41; (3) Neville, C., et al. (2012). "The Watermemories Swim Club for People with Dementia." Journal of Ageing and Physical Activity. 20(August): S8 - 10.) Finally, we aim to create a sustainable, cost-effective, evidence-based exercise program that can be easily accessed and implemented by RACFs, independent of a research environment. To achieve this objective, we intend to disseminate manuals describing the WSC program and outlining in detail how it can be implemented, so that it may be incorporated into RACFs in other areas of Australia 

Broad Health ConditionDementia

Specific Health ConditionPhysical Medicine / Rehabilitation
Other physical medicine / rehabilitation
Neurological
Dementias

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Anticipated date of first participant enrolment30/04/2013

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Past history of swimming 
2. Residing in a residential aged care facility (low or high care)
3. Diagnosis of dementia 
4. Able to walk a minimum of 10 metres self-ambulating or with a walking cane or wheelie walker 

Minimum age65 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Unstable or terminal illness
2. Wheel-chair or bed bound 
3. Medications contradictory to exercise 
4. Unable to obtain medical clearance from GP to participate
5. Unable to obtain substitute decision-maker consent
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Dr Tim Henwood
Primary Sponsor Address: UQ / Blue Care Research & Practice Development Centre 56 Sylvan Rd TOOWONG QLD 4066
Primary Sponsor Country: Australia

Trial IDACTRN12613000503729

UTNN/A

Contact person for information and recruitmentMs
Chantelle Baguley
UQ / Blue Care Research & Practice Development Centre 56 Sylvan Rd TOOWONG QLD 4066
+61 7 3720 5620

Further information iconc.baguley1@uq.edu.au
Australia

Testing an online intervention to improve the sun protective behaviour of Australian adults.

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Trial Information

Trial summary

The aim of this study is to evaluate the effect of an online intervention in improving the sun protective behaviour of Australian adults. Who is it for? You may be eligible to join this study if you are aged 18 years or above and live in metropolitan, regional or coastal areas of Queensland, Australia. Trial details: Participants in this trial will be randomly (by chance) allocated to one of three groups: the intervention group, the information only group, or the control group. Participants in the intervention group will receive the online intervention which focuses on encouraging supportive sun protective attitudes and beliefs, fostering perceptions of normative support for sun protection behaviour and increasing perceptions of control/self-efficacy over using sun protection. It will be delivered during one online session lasting between 20 and 25 minutes. Participants in the information only group will be asked to view a short online DVD and three fact sheets relating to sun-protective behaviour which are currently available from Cancer Council Queensland’s website. Data on intentions to sun protect and sun protection behaviour will be collected via questionnaire immediately prior to the intervention (Time 1), immediately following the intervention (Time 2) and at one week (Time 3) and four weeks (Time 4) post-intervention. The control group will not be asked to do anything beyond completing the 3 questionnaires. The study will provide valuable information about the effectiveness of the intervention in improving the sun protective behaviour of Australian adults – a population which has the highest incident rates of skin cancer in the world (Queensland).

Broad Health ConditionSun preventative-behaviours

Specific Health ConditionPublic Health
Health promotion/education
Cancer
Non melanoma skin cancer
Cancer
Malignant melanoma

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Anticipated date of first participant enrolment5/03/2013

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Eligibility criteria include male and female adults, living in metropolitan, regional, and coastal areas of Queensland, Australia.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

nil
Contact details and further information

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

Trial websitehttp://sunsafestudy.com.au

Trial IDACTRN12613000470796

Contact person for information and recruitmentProf
Katherine White
School of Psychology and Counselling, Queensland University of Technology, Victoria Park Road, Kelvin Grove. Brisbane, Queensland 4059, AUSTRALIA
+61 07 3138 4689

Further information iconkm.white@qut.edu.au
Australia

An interdisciplinary model to enhance care of older patients undergoing vascular surgery

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Trial Information

Trial summary

In this study, the research group will work with staff on a vascular surgical ward to design and introduce changes to care which are more elder-friendly, to ensure that older patients regain their usual function faster after surgery. This will include prompt input from a physician to prevent early medical complications, early input from allied health professionals such as physiotherapists and nutritionists to reduce the risks of muscle loss, and resular encouragement from all staff members to keep their body and mind as active as possible. The changes in care will be made by working closely with ward staff using an evidence-based framework for implementing complex changes in health care settings. 
The investigators hope to show that the new model of care improves the rate of return to independence, reduces complications and reduces length of stay in this high risk patient group, compared to the usual way of organising care. They will also assess whether these improvements justify the additional intensity (and therefore cost) of staffing which would be necessary to provide this enhanced care.

Broad Health ConditionVascular surgery

Specific Health ConditionSurgery
Other surgery
Cardiovascular
Diseases of the vasculature and circulation including the lymphatic system

Trial FocusTreatment

Recruitment statusRecruiting

Anticipated date of first participant enrolment1/08/2012

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Aged 65 or older, admitted to vascular surgical unit with anticipated length of stay at least 3 days

Minimum age65 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Unable to be reviewed within 4 days of admission
Unable to consent and no statutory health authority available
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australian Centre for Health Services Innovation
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 IDACTRN12612001201864

UTNU1111-1133-2422

Contact person for information and recruitment
Prof Alison Mudge
Internal Medicine and Aged Care Royal Brisbane and Women's Hospital Herston 4029 Queensland
61 7 36468111
61 7 36467800
Further information iconAlison_Mudge@health.qld.gov.au
Australia