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Trial registered on ANZCTR
Registration number
ACTRN12609000333213
Ethics application status
Approved
Date submitted
8/04/2009
Date registered
22/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
A collaborative model of care for the management of type 2 diabetes mellitus (T2DM), coronary heart disease (CHD) and co-morbid depression
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Scientific title
In type 2 diabetes and/or Coronary Heart Disease patients, is collaborative care or usual care more effective in reducing depression scores?
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Universal Trial Number (UTN)
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Trial acronym
True Blue Project
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus and Co-morbid depression
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Coronary Heart Disease and Co-morbid depression
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Condition category
Condition code
Mental Health
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0
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Depression
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Cardiovascular
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0
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Coronary heart disease
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Metabolic and Endocrine
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
At baseline, eligible patients in treatment practices (ie those with T2DM &/or CHD and will be screened for depression using the Patient Health Questionnaire (PHQ-9) . A score of 5 or over indicates the patient has mild, moderate, moderately severe or severe depression and is eligible for inclusion in the study.
These patients will be recalled for an assessment of lifetyle, biometric (see Key secondary outcome below) and psychological risk factors.
Based on this assessment, a Practice Nurse will draft a Care Plan jointly with the patient prioritising risk factors and documenting appropriate behavioural goals to ameliorate these risk factors. The Plan will be reviewed by the patient's General Practitioner (GP) and endorsed or revised as appropriate.
The treatment goals may comprise a range of interventions including:
Medication (eg selective serotonin reuptake inhibitors, mood stabilisers)
Psychological counselling (eg one on one group sessions with a psychologist using cognitive behavioural techniques) over three to six months.
Exercise program (this might consist of a range of approaches, depending on patient preferences and resource availability; eg a self led personal exercise program such a regular walking; a referral to a gym or an exercise physiologist, the latter initially for an Medical Benefits Schedule subsidised 8 session group program based on an individualised assessment. Further participation will be subject to user pays )
Patients will then be recalled for regular monitoring by the practice nuse/GP team at 3, 6 9 and 12 months visits.
At each visit the patients progress will be reviewed:
The patient's goals set at the previous session will be reviewed, outcomes recorded and goals changed or modifed if appropriate.
The PHQ-9 questionnaire will be re-administered and the patient's score will be monitored to guide any changes to the treatment care plan.
A quality of life measure (Short Form 36 [SF36 version 2] will be administered at baseline and 6 and 12 month visits.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
participating General Practitioners (GPs) in control practices will be advised of the identity codes of patients who have scored 5 or over on the PHQ-9 instrument (ie indicative for mild, moderate, moderate severe or severe depression) and asked to provide them with non defined usual care for 6 months. Intervention will be at the GPs discretion.
Such usual care may comprise a range of interventions by the GP or the Practice Nurse including the following:
it may or may not include medication (eg selective serotonin reuptake inhibitors, mood stabilisers)
it may or may not include psychological counselling (eg one on one group sessions with a psychologist using cognitive behavioural techniques) over three to six months
It may or may not include an exercise program (eg referral to an exercise physiologist or gym)
Pateints may or may not be recalled for regular monitoring by the practice nuse/GP team at intervals.
The patients progress may or may not be reviewed:
Behavioural goals for the patient may or may not be set
Behavioural goals may or may not be reviewed at subsequent visits
Outcomes may or may not be recorded and goals changed or modifed if appropriate.
At the end of of the 6 month period of usual care:
the PHQ-9 questionnaire will be re-administered.
A quality of life measure (Short Form 36 [SF36 version 2] will be administered.
The nature of intervention for each patient that was initiated by the Control Practice over the previous six months will be documented.
There are fundamental differences between the interventions for patients in the Treatment practices and the Control practices: eg
In the former, patients will experience a mandated twelve month period of regular review at three monthly intervals.
Their care will be provide by a team comprising a Practice Nurse and GP
A Care Plan detailing key risk factors (Lifestyle, biometric and psychological) will be prepared and behavioural goals set and reviewed systematically
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Control group
Active
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Outcomes
Primary outcome [1]
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% of patients with 50% improvement in the patient's psychological health (as measured by the Patient Health Questionnaire (PHQ-9) score)
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Assessment method [1]
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Timepoint [1]
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3, 6, 9 and 12 months after commencement of treatment
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Secondary outcome [1]
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% of patients with improved biometric measures using blood analysis and physical measurement; including
glycosated hemoglobin (HbA1c) High density lipo-proteins (HDL) Low density lipo-proteins (LDL) Systolic and diastolic blood pressure (BP) Waist circumference and Body/Mass Index (BMI)
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Assessment method [1]
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Timepoint [1]
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6 months after identification and recruitment of control patients into usual care.
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Secondary outcome [2]
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Improved quality of life (as measured by SF36v2 scores )
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Assessment method [2]
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Timepoint [2]
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6 and 12 months after commencement of treatment
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Eligibility
Key inclusion criteria
All patients with a diagnosis of type 2 diabetes and/or coronary heart disease and depression (as measured by a PHQ-9 score of 5 or over indicative of mild, moderate, moderate severe or severe depression)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
subjects in Residential Care Facilities or lacking testamentary capacity
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Meetings at three sites (northern Rivers, Melbourne and Adelaide South and West) were organised by the local Division (Network) of General Practice. Invitations to atttend the meeting were issued to all practices in the three study areas. Divisional staff subsequently interviewed practice representatives who had expressed an interest in participating until the quota for each area was reached (6,6,3 and 3). The practices who agreed to participate were then randomly allocated to the treatment cluster and control cluster using a computer based random number generator.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Practices in selected study area allocated using random number generator
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
31/07/2008
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
900
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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beyond blue
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Address [1]
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50 Burwood Road
Hawthorn
Victoria 3122
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Greater Green Triangle University Department of Rural Health
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Address
PO Box 423
Warrnambool
Victoria 3280
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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Northern Rivers University Department of Rural Health
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Address [1]
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16 Carrington Street (PO Box 519), Lismore, NSW 2480
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Country [1]
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Australia
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Other collaborator category [1]
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Other Collaborative groups
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Name [1]
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Southern Divsion of General Practice
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Address [1]
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Level 3A, 5 Laffer Drive,
Sir Mark Oliphant Building,
Bedford Park SA 5042
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Flinders University Social and Behavioural Ethic Committee
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Ethics committee address [1]
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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05/05/2008
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Approval date [1]
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06/08/2008
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Ethics approval number [1]
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4164
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Summary
Brief summary
Study aims to identify whether there are significant differences between the outcomes achieved through a collaborative intervention in a sample of patients diagnosed with depression, T2DM and CHD and usual care.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Robert Leahy
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Address
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PO Box 423
Warrnambool Victoria 3280
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Country
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Australia
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Phone
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+61 3 55633562 or +61 0448559905
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Fax
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+61 3 55633144
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof James Dunbar
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Address
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PO Box 423
Warrnambool Victoria 3280
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Country
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Australia
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Phone
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+61 3 55633315
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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