Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12609000386235
Ethics application status
Approved
Date submitted
11/03/2009
Date registered
29/05/2009
Date last updated
5/07/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
A randomised controlled trial managing co-morbid depression after Acute Coronary Syndrome (ACS): MoodCare
Query!
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
Query!
Secondary ID [1]
253113
0
The MOOD-CARE trial
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
MOOD-CARE (Managing cO-mOrbid Depression: Coronary Aftercare Randomized Evaluation)
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Depression
4452
0
Query!
Condition category
Condition code
Mental Health
4721
4721
0
0
Query!
Depression
Query!
Cardiovascular
4974
4974
0
0
Query!
Coronary heart disease
Query!
Intervention/exposure
Study type
Interventional
Query!
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).
Query!
Intervention code [1]
4197
0
Behaviour
Query!
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
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
5589
0
Depression Outcomes (Cardiac Depression Scale)
Query!
Assessment method [1]
5589
0
Query!
Timepoint [1]
5589
0
6, 12, 24 months following the commencement of treatment
Query!
Secondary outcome [1]
9418
0
Health Related Quality of Life (SF-12)
Query!
Assessment method [1]
9418
0
Query!
Timepoint [1]
9418
0
6, 12, 24 months following the commencement of treatment
Query!
Secondary outcome [2]
241825
0
Employment status, productivity and absenteeism (collected via self report questionnaire; a component of the Compute Assisted Telephone Interview)
Query!
Assessment method [2]
241825
0
Query!
Timepoint [2]
241825
0
6, 12, 24 months following the commencement of treatment
Query!
Secondary outcome [3]
266443
0
physical activity (collected via postal survey using the Active Australia Survey)
Query!
Assessment method [3]
266443
0
Query!
Timepoint [3]
266443
0
6, 12, 24 months following the commencement of treatment
Query!
Secondary outcome [4]
266444
0
alcohol (collected via postal survey using the Cancer Council Food Frequency Questionnaire)
Query!
Assessment method [4]
266444
0
Query!
Timepoint [4]
266444
0
6, 12, 24 months following the commencement of treatment
Query!
Secondary outcome [5]
266445
0
smoking (collected via postal survey using the Cancer Council Food Frequency Questionnaire)
Query!
Assessment method [5]
266445
0
Query!
Timepoint [5]
266445
0
6, 12, 24 months following the commencement of treatment
Query!
Secondary outcome [6]
266446
0
fat intake (collected via postal survey using the Short Fat Questionnaire)
Query!
Assessment method [6]
266446
0
Query!
Timepoint [6]
266446
0
6, 12, 24 months following the commencement of treatment
Query!
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)
Query!
Assessment method [7]
266447
0
Query!
Timepoint [7]
266447
0
6, 12, 24 months following the commencement of treatment
Query!
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
Query!
Minimum age
21
Years
Query!
Query!
Maximum age
85
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Inability to give informed consent, patients with a life threatening illness, waiting for surgical intervention or inability to comprehend English
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
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)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple computer generated random number sampling.
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
8/02/2010
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
100
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Funding source category [1]
4643
0
Government body
Query!
Name [1]
4643
0
Commonwealth Department of Health and Ageing
Query!
Address [1]
4643
0
GPO Box 9848
Canberra
ACT 2601
Query!
Country [1]
4643
0
Australia
Query!
Primary sponsor type
University
Query!
Name
School of Public Health and Preventive Medicine, Monash University
Query!
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
Query!
Country
Australia
Query!
Secondary sponsor category [1]
4190
0
None
Query!
Name [1]
4190
0
N/a
Query!
Address [1]
4190
0
N/a
Query!
Country [1]
4190
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
239151
0
Royal Brisbane and Women's Hospital
Query!
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
Query!
Ethics committee country [1]
239151
0
Australia
Query!
Date submitted for ethics approval [1]
239151
0
24/03/2009
Query!
Approval date [1]
239151
0
15/05/2009
Query!
Ethics approval number [1]
239151
0
EC00172
Query!
Ethics committee name [2]
260075
0
The Austin Hospital
Query!
Ethics committee address [2]
260075
0
145 Studley Road PO Box 5555 Heidelberg Victoria
Query!
Ethics committee country [2]
260075
0
Australia
Query!
Date submitted for ethics approval [2]
260075
0
Query!
Approval date [2]
260075
0
12/10/2009
Query!
Ethics approval number [2]
260075
0
H2009/03647
Query!
Ethics committee name [3]
260076
0
The Prince Charles Hospital
Query!
Ethics committee address [3]
260076
0
Rode Road, Chermside, Queensland, 4032
Query!
Ethics committee country [3]
260076
0
Australia
Query!
Date submitted for ethics approval [3]
260076
0
Query!
Approval date [3]
260076
0
05/10/2009
Query!
Ethics approval number [3]
260076
0
HREC/09/QPCH/126
Query!
Ethics committee name [4]
260077
0
The Royal Melbourne Hospital
Query!
Ethics committee address [4]
260077
0
PO The Royal Melbourne Hospital Parkville Victoria 3050
Query!
Ethics committee country [4]
260077
0
Australia
Query!
Date submitted for ethics approval [4]
260077
0
Query!
Approval date [4]
260077
0
04/03/2010
Query!
Ethics approval number [4]
260077
0
2010.020
Query!
Ethics committee name [5]
260078
0
Monash University
Query!
Ethics committee address [5]
260078
0
SCERH Committee, Monash University Clayton Campus, Wellington Road, Clayton Victoria 3169
Query!
Ethics committee country [5]
260078
0
Australia
Query!
Date submitted for ethics approval [5]
260078
0
Query!
Approval date [5]
260078
0
23/06/2009
Query!
Ethics approval number [5]
260078
0
2009000933
Query!
Ethics committee name [6]
260079
0
St Vincent?s Hospital
Query!
Ethics committee address [6]
260079
0
PO Box 2900 Fitzroy Victoria 3065
Query!
Ethics committee country [6]
260079
0
Australia
Query!
Date submitted for ethics approval [6]
260079
0
Query!
Approval date [6]
260079
0
14/09/2009
Query!
Ethics approval number [6]
260079
0
084/09
Query!
Ethics committee name [7]
260080
0
The Geelong Hospital
Query!
Ethics committee address [7]
260080
0
PO BOX 281 Geelong Victoria 3220
Query!
Ethics committee country [7]
260080
0
Australia
Query!
Date submitted for ethics approval [7]
260080
0
Query!
Approval date [7]
260080
0
08/09/2010
Query!
Ethics approval number [7]
260080
0
10/79
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
29378
0
Query!
Address
29378
0
Query!
Country
29378
0
Query!
Phone
29378
0
Query!
Fax
29378
0
Query!
Email
29378
0
Query!
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
Query!
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
Query!
Country
12625
0
Australia
Query!
Phone
12625
0
+61 3 99030512
Query!
Fax
12625
0
+61 3 99030556
Query!
Email
12625
0
[email protected]
Query!
Contact person for scientific queries
Name
3553
0
Prof Brian Oldenburg
Query!
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
Query!
Country
3553
0
Australia
Query!
Phone
3553
0
+61 3 9903 0046
Query!
Fax
3553
0
+61 3 9903 0556
Query!
Email
3553
0
[email protected]
Query!
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
Source
Title
Year of Publication
DOI
Embase
A randomised, feasibility trial of a tele-health intervention for Acute Coronary Syndrome patients with depression ('MoodCare'): Study protocol.
2011
https://dx.doi.org/10.1186/1471-2261-11-8
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF