Trial registered on ANZCTR


Trial ID
ACTRN12609000386235
Ethics application status
Approved
Date submitted
11/03/2009
Date registered
29/05/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial managing co-morbid depression after Acute Coronary Syndrome (ACS): MoodCare
Scientific title
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
Secondary ID [1] 253113 0
The MOOD-CARE trial
Universal Trial Number (UTN)
Trial acronym
MOOD-CARE (Managing cO-mOrbid Depression: Coronary Aftercare Randomized Evaluation)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 4452 0
Condition category
Condition code
Mental Health 4721 4721 0 0
Depression
Cardiovascular 4974 4974 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description 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).
Intervention code [1] 4197 0
Behaviour
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
Control group
Active

Outcomes
Primary outcome [1] 5589 0
Depression Outcomes (Cardiac Depression Scale)
Timepoint [1] 5589 0
6, 12, 24 months following the commencement of treatment
Secondary outcome [1] 9418 0
Health Related Quality of Life (SF-12)
Timepoint [1] 9418 0
6, 12, 24 months following the commencement of treatment
Secondary outcome [2] 241825 0
Employment status, productivity and absenteeism (collected via self report questionnaire; a component of the Compute Assisted Telephone Interview)
Timepoint [2] 241825 0
6, 12, 24 months following the commencement of treatment
Secondary outcome [3] 266443 0
physical activity (collected via postal survey using the Active Australia Survey)
Timepoint [3] 266443 0
6, 12, 24 months following the commencement of treatment
Secondary outcome [4] 266444 0
alcohol (collected via postal survey using the Cancer Council Food Frequency Questionnaire)
Timepoint [4] 266444 0
6, 12, 24 months following the commencement of treatment
Secondary outcome [5] 266445 0
smoking (collected via postal survey using the Cancer Council Food Frequency Questionnaire)
Timepoint [5] 266445 0
6, 12, 24 months following the commencement of treatment
Secondary outcome [6] 266446 0
fat intake (collected via postal survey using the Short Fat Questionnaire)
Timepoint [6] 266446 0
6, 12, 24 months following the commencement of treatment
Secondary outcome [7] 266447 0
social support (collected via self report questionnaire using the ENRICHD social support inventory; a component of the Compute Assisted Telephone Interview)
Timepoint [7] 266447 0
6, 12, 24 months following the commencement of treatment

Eligibility
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
Minimum age
21 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give informed consent, patients with a life threatening illness, waiting for surgical intervention or inability to comprehend English

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)
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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple computer generated random number sampling.
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

Recruitment
Anticipated date of first participant enrolment
8/02/2010
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Anticipated date of last data collection
Actual date of last data collection
Target sample size
100
Actual sample size
Recruitment status
Recruiting
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4643 0
Government body
Name [1] 4643 0
Commonwealth Department of Health and Ageing
Address [1] 4643 0
GPO Box 9848
Canberra
ACT 2601
Country [1] 4643 0
Australia
Primary sponsor type
University
Name
School of Public Health and Preventive Medicine, Monash University
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
Country
Australia
Secondary sponsor category [1] 4190 0
None
Name [1] 4190 0
N/a
Address [1] 4190 0
N/a
Country [1] 4190 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239151 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 239151 0
Human Research Ethics Office
Level 7, Block 7 Cnr Butterfield St and Bowen Bridge Rd HERSTON, QUEENSLAND AUSTRALIA 4029
Ethics committee country [1] 239151 0
Australia
Date submitted for ethics approval [1] 239151 0
24/03/2009
Approval date [1] 239151 0
15/05/2009
Ethics approval number [1] 239151 0
EC00172
Ethics committee name [2] 260075 0
The Austin Hospital
Ethics committee address [2] 260075 0
145 Studley Road
PO Box 5555
Heidelberg Victoria
Ethics committee country [2] 260075 0
Australia
Date submitted for ethics approval [2] 260075 0
Approval date [2] 260075 0
12/10/2009
Ethics approval number [2] 260075 0
H2009/03647
Ethics committee name [3] 260076 0
The Prince Charles Hospital
Ethics committee address [3] 260076 0
Rode Road, Chermside, Queensland, 4032
Ethics committee country [3] 260076 0
Australia
Date submitted for ethics approval [3] 260076 0
Approval date [3] 260076 0
05/10/2009
Ethics approval number [3] 260076 0
HREC/09/QPCH/126
Ethics committee name [4] 260077 0
The Royal Melbourne Hospital
Ethics committee address [4] 260077 0
PO The Royal Melbourne Hospital
Parkville Victoria 3050
Ethics committee country [4] 260077 0
Australia
Date submitted for ethics approval [4] 260077 0
Approval date [4] 260077 0
04/03/2010
Ethics approval number [4] 260077 0
2010.020
Ethics committee name [5] 260078 0
Monash University
Ethics committee address [5] 260078 0
SCERH Committee,
Monash University Clayton Campus,
Wellington Road,
Clayton Victoria 3169
Ethics committee country [5] 260078 0
Australia
Date submitted for ethics approval [5] 260078 0
Approval date [5] 260078 0
23/06/2009
Ethics approval number [5] 260078 0
2009000933
Ethics committee name [6] 260079 0
St Vincent?s Hospital
Ethics committee address [6] 260079 0
PO Box 2900 Fitzroy Victoria 3065
Ethics committee country [6] 260079 0
Australia
Date submitted for ethics approval [6] 260079 0
Approval date [6] 260079 0
14/09/2009
Ethics approval number [6] 260079 0
084/09
Ethics committee name [7] 260080 0
The Geelong Hospital
Ethics committee address [7] 260080 0
PO BOX 281
Geelong Victoria 3220
Ethics committee country [7] 260080 0
Australia
Date submitted for ethics approval [7] 260080 0
Approval date [7] 260080 0
08/09/2010
Ethics approval number [7] 260080 0
10/79

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29378 0
Address 29378 0
Country 29378 0
Phone 29378 0
Fax 29378 0
Email 29378 0
Contact person for public queries
Name 12625 0
Bianca Chan begin_of_the_skype_highlighting     end_of_the_skype_highlighting begin_of_the_skype_highlighting     end_of_the_skype_highlighting
Address 12625 0
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
Country 12625 0
Australia
Phone 12625 0
+61 3 99030512
Fax 12625 0
+61 3 99030556
Email 12625 0
bianca.chan@monash.edu
Contact person for scientific queries
Name 3553 0
Prof Brian Oldenburg
Address 3553 0
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
Country 3553 0
Australia
Phone 3553 0
+61 3 9903 0046
Fax 3553 0
+61 3 9903 0556
Email 3553 0
Brian.Oldenburg@med.monash.edu.au