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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
Scientific title
In type 2 diabetes and/or Coronary Heart Disease patients, is collaborative care or usual care more effective in reducing depression scores?
Universal Trial Number (UTN)
Trial acronym
True Blue Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus and Co-morbid depression 3618 0
Coronary Heart Disease and Co-morbid depression 3619 0
Condition category
Condition code
Mental Health 3777 3777 0 0
Depression
Cardiovascular 3778 3778 0 0
Coronary heart disease
Metabolic and Endocrine 3780 3780 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 3330 0
Treatment: Other
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
Control group
Active

Outcomes
Primary outcome [1] 4672 0
% of patients with 50% improvement in the patient's psychological health (as measured by the Patient Health Questionnaire (PHQ-9) score)
Timepoint [1] 4672 0
3, 6, 9 and 12 months after commencement of treatment
Secondary outcome [1] 7893 0
% 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)
Timepoint [1] 7893 0
6 months after identification and recruitment of control patients into usual care.
Secondary outcome [2] 242112 0
Improved quality of life (as measured by SF36v2 scores )
Timepoint [2] 242112 0
6 and 12 months after commencement of treatment

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
subjects in Residential Care Facilities or lacking testamentary capacity

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Practices in selected study area allocated using random number generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3795 0
Charities/Societies/Foundations
Name [1] 3795 0
beyond blue
Country [1] 3795 0
Australia
Primary sponsor type
University
Name
Greater Green Triangle University Department of Rural Health
Address
PO Box 423
Warrnambool
Victoria 3280
Country
Australia
Secondary sponsor category [1] 3405 0
University
Name [1] 3405 0
Northern Rivers University Department of Rural Health
Address [1] 3405 0
16 Carrington Street (PO Box 519), Lismore, NSW 2480
Country [1] 3405 0
Australia
Other collaborator category [1] 390 0
Other Collaborative groups
Name [1] 390 0
Southern Divsion of General Practice
Address [1] 390 0
Level 3A, 5 Laffer Drive,
Sir Mark Oliphant Building,
Bedford Park SA 5042
Country [1] 390 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5854 0
Flinders University Social and Behavioural Ethic Committee
Ethics committee address [1] 5854 0
Ethics committee country [1] 5854 0
Australia
Date submitted for ethics approval [1] 5854 0
05/05/2008
Approval date [1] 5854 0
06/08/2008
Ethics approval number [1] 5854 0
4164

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28882 0
Address 28882 0
Country 28882 0
Phone 28882 0
Fax 28882 0
Email 28882 0
Contact person for public queries
Name 12039 0
Robert Leahy
Address 12039 0
PO Box 423
Warrnambool Victoria 3280
Country 12039 0
Australia
Phone 12039 0
+61 3 55633562 or +61 0448559905
Fax 12039 0
+61 3 55633144
Email 12039 0
bob.leahy@greaterhealth.org
Contact person for scientific queries
Name 2967 0
Prof James Dunbar
Address 2967 0
PO Box 423
Warrnambool Victoria 3280
Country 2967 0
Australia
Phone 2967 0
+61 3 55633315
Fax 2967 0
Email 2967 0
Director@greaterhealth.org

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
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Documents added automatically
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