Trial from ANZCTR


Trial ID ACTRN12609000386235
Trial Status: Registered
Date Submitted: 11/03/2009
Date Registered: 29/05/2009
Prospectively registered

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Public title A randomised controlled trial managing co-morbid depression after Acute Coronary Syndrome (ACS): MoodCare
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format The impact of a telephone-delivered depression management program (MOOD-CARE) on the health and depression outcomes of heart attack [Acute Coronary Syndrome (ACS)] patients compared to Usual Care
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Secondary ID [1] 253113 0
The MOOD-CARE trial
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UTN
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Trial acronym MOOD-CARE (Managing cO-mOrbid Depression: Coronary Aftercare Randomized Evaluation)
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Health condition(s) or problem(s) studied:
Depression 4452 0
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Condition category: Condition code:
Mental Health Depression
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4721 4721 0 0
Cardiovascular Coronary heart disease
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4974 4974 0 0

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Descriptions of intervention(s) / exposure MOODCARE includes up to 10 telephone counselling sessions,each approximately 30 minutes in duration, over 6 months after hospital discharge for ACS, using Cognitive Behaviour Therapy (CBT) delivered by psychologists. The sessions will be most intensive over the first 3 months when depressive symptoms are most likely to affect patients following ACS and to impact on their quality of life and adoption of secondary preventive behaviours. Psychologists will aim to reduce symptoms of depression, as well as improve Coronary Heart Disease (CHD) risk factors and overall Quality Of Life (QOL).
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Intervention Code:
Behaviour 4197 0
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Comparator / control treatment Usual Care (UC) will involve standard treatment (e.g cardiac rehabilitation) following discharge for ACS. It is recognised that there will be variation between the cardiac rehabilitation programs offered to those participants assigned to the Usual Care (UC) group not only between hospitals but between states. However, we anticipate that the standard cardiac rehabilitation offered to those in the control group will have the following characteristics: (1) three identified phases: Inpatient rehabilitation (Phase 1), Ambulatory outpatient rehabilitation (Phase 2), Maintenance (Phase 3), (2) the usual duration of programs will be six to eight weeks, (although in some places it may be as short as four weeks), (3) Sessions may be offered once, twice or occasionally three times per week, (4) most exercise programs will be of low or moderate intensity, (5) most programs will include group education, but the content and method of the delivery of such education programs will most likely vary greatly, (6) Psychological and social support may be given on an individual basis, as required, or may be provided to groups of patients and family members. Participants in UC condition will receive general health newsletters from the project team every six months for 24 months
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Control group Active
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Primary Outcome: Depression Outcomes (Cardiac Depression Scale) 5589 0
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Timepoint: 6, 12, 24 months following the commencement of treatment 5589 0
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Secondary Outcome: Health Related Quality of Life (SF-12) 9418 0
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Timepoint: 6, 12, 24 months following the commencement of treatment 9418 0
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Secondary Outcome: Employment status, productivity and absenteeism (collected via self report questionnaire; a component of the Compute Assisted Telephone Interview) 241825 0
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Timepoint: 6, 12, 24 months following the commencement of treatment 241825 0
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Secondary Outcome: physical activity (collected via postal survey using the Active Australia Survey) 266443 0
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Timepoint: 6, 12, 24 months following the commencement of treatment 266443 0
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Secondary Outcome: alcohol (collected via postal survey using the Cancer Council Food Frequency Questionnaire) 266444 0
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Timepoint: 6, 12, 24 months following the commencement of treatment 266444 0
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Secondary Outcome: smoking (collected via postal survey using the Cancer Council Food Frequency Questionnaire) 266445 0
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Timepoint: 6, 12, 24 months following the commencement of treatment 266445 0
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Secondary Outcome: fat intake (collected via postal survey using the Short Fat Questionnaire) 266446 0
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Timepoint: 6, 12, 24 months following the commencement of treatment 266446 0
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Secondary Outcome: social support (collected via self report questionnaire using the ENRICHD social support inventory; a component of the Compute Assisted Telephone Interview) 266447 0
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Timepoint: 6, 12, 24 months following the commencement of treatment 266447 0
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Key inclusion criteria Participants include those: (i) aged 21-85; (ii) with a clinical diagnosis consistent with that of ACS (Myocardial Infarction [STEMI or non STEMI], unstable angina, by confirmed angiogram); admitted to 6 large, tertiary referral hospitals in Brisbane and Melbourne; (iii) with the ability to understand and provide written informed consent in English; (iv) with access to a telephone during the intervention period and (v) recording a Patient Health Questionnaire (PHQ9) score of 5-19
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Minimum age 21 Years
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Maximum age 85 Years
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria Inability to give informed consent, patients with a life threatening illness, waiting for surgical intervention or inability to comprehend English
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) All consenting patients will be assessed for depression prior to hospital discharge, using psychometrically robust and valid instruments, i.e., the Patient Health Questionnaire (PHQ9). Patients identified in hospital with a score on the PHQ9=5-19, will be contacted by a Research Assistant (RA) via telephone within 1-2 week of discharge for baseline assessment which includes a diagnostic assessment using Composite International Diagnostic Interview (CIDI). Following this, patients will be randomised (central randomisation via project website) to either usual care or the telephone-based care management program for depression (MOOD-CARE)
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Simple computer generated random number sampling.
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 8/02/2010
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 100
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Recruitment status Recruiting
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

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Funding Source: Government body 4643 0
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Name: Commonwealth Department of Health and Ageing 4643 0
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Address: GPO Box 9848
Canberra
ACT 2601
4643 0
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Country: Australia 4643 0
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Primary Sponsor University
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Name: School of Public Health and Preventive Medicine, Monash University
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Address: School of Public Health and Preventive Medicine, Department of Epidemiology and Preventive Medicine Monash University Alfred Hospital Campus Level 3 (Burnet Tower) 89 Commercial Road Melbourne VIC 3004
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Country: Australia
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Secondary Sponsor: None 4190 0
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Name: N/a 4190 0
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Address: N/a 4190 0
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Country: Australia 4190 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Royal Brisbane and Women's Hospital 239151 0
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Address: Human Research Ethics Office
Level 7, Block 7 Cnr Butterfield St and Bowen Bridge Rd HERSTON, QUEENSLAND AUSTRALIA 4029
239151 0
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Country: Australia 239151 0
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Approval Date: 15/05/2009 239151 0
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Submitted Date: 24/03/2009 239151 0
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HREC: EC00172 239151 0
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Ethics Committee name: The Austin Hospital 260075 0
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Address: 145 Studley Road
PO Box 5555
Heidelberg Victoria
260075 0
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Country: Australia 260075 0
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Approval Date: 12/10/2009 260075 0
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Submitted Date: 260075 0
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HREC: H2009/03647 260075 0
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Ethics Committee name: The Prince Charles Hospital 260076 0
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Address: Rode Road, Chermside, Queensland, 4032 260076 0
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Country: Australia 260076 0
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Approval Date: 05/10/2009 260076 0
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Submitted Date: 260076 0
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HREC: HREC/09/QPCH/126 260076 0
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Ethics Committee name: The Royal Melbourne Hospital 260077 0
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Address: PO The Royal Melbourne Hospital
Parkville Victoria 3050
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Country: Australia 260077 0
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Approval Date: 04/03/2010 260077 0
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Submitted Date: 260077 0
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HREC: 2010.020 260077 0
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Ethics Committee name: Monash University 260078 0
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Address: SCERH Committee,
Monash University Clayton Campus,
Wellington Road,
Clayton Victoria 3169
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Country: Australia 260078 0
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Approval Date: 23/06/2009 260078 0
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Submitted Date: 260078 0
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HREC: 2009000933 260078 0
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Ethics Committee name: St Vincent?s Hospital 260079 0
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Address: PO Box 2900 Fitzroy Victoria 3065 260079 0
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Country: Australia 260079 0
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Approval Date: 14/09/2009 260079 0
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Submitted Date: 260079 0
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HREC: 084/09 260079 0
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Ethics Committee name: The Geelong Hospital 260080 0
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Address: PO BOX 281
Geelong Victoria 3220
260080 0
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Country: Australia 260080 0
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Approval Date: 08/09/2010 260080 0
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Submitted Date: 260080 0
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HREC: 10/79 260080 0
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Brief summary We will recruit ACS patients who exhibit signs of depression from six hospitals, randomise them to MOOD-CARE or usual care (UC), and follow them for up to 2 years. MOOD-CARE is a state-of-the-art telephone counselling program which has the potential to improve psychological, physical, social and vocational functioning; reduce demands on the health system; and potentially, to extend survival for the growing number of Coronary Heart Disease patients in Australia.
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Bianca Chan begin_of_the_skype_highlighting     end_of_the_skype_highlighting begin_of_the_skype_highlighting     end_of_the_skype_highlighting
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Address: School of Public Health and Preventive Medicine, Department of Epidemiology and Preventive Medicine Monash University Alfred Hospital Campus Level 3 (Burnet Tower) 89 Commercial Road Melbourne VIC 3004
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Country: Australia
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Tel: +61 3 99030512
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Fax: +61 3 99030556
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Email: bianca.chan@monash.edu
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Contact person for scientific queries
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Name: Prof Brian Oldenburg
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Address: School of Public Health and Preventive Medicine, Department of Epidemiology and Preventive Medicine Monash University Alfred Hospital Campus Level 3 (Burnet Tower) 89 Commercial Road Melbourne VIC 3004
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Country: Australia
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Tel: +61 3 9903 0046
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Fax: +61 3 9903 0556
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Email: Brian.Oldenburg@med.monash.edu.au
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Contact person responsible for updating information
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Name: Adrienne O'Neil
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Address: School of Public Health and Preventive Medicine, Department of Epidemiology and Preventive Medicine Monash University Alfred Hospital Campus Level 3 (Burnet Tower) 89 Commercial Road Melbourne VIC 3004
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Country: Australia
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Tel: +61 3 99030512
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Fax: +61 3 99030556
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Email: adrienne.o'neil@med.monash.edu.au
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Addition Cancer fields
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