Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000595415
Ethics application status
Approved
Date submitted
12/11/2007
Date registered
19/11/2007
Date last updated
29/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
An implementation trial of a telephone-based care management program for patients following myocardial infarction.
Scientific title
The impact of a telephone-based care management intervention on clinical and lifestyle outcomes in patients following myocardial infarction. A randomised controlled trial.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial infarction. 2538 0
Condition category
Condition code
Cardiovascular 2637 2637 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of a telephone-based care management program delivered over a period of 6 months during which the participant will receive 10 x 20 minute telephone coaching sessions. Participants will receive an interactive workbook and educational resource. In addition to the initial telephone call, the care manager will call the participant 9 more times during weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24 (final call). Following the initial call, the remaining calls will be structured as follows: 1) introduction & identification of any new symptoms or change in symptoms, i.e., identification of any new alerts; 2) follow-up on progress towards previous lifestyle/clinical goals and targets; 3) assess and counsel on relevant behavioural, psychological and social and clinical risk factors, as well as, to encourage treatment/medication compliance; 4) review session, summarise next tasks/actions, patient to record these in their Workbook and agree on time for next phone call. The topics to be covered by the Care Manager (CM) are informed and under-pinned by the guidelines for the management of people with coronary heart disease, including, attention being given to:
1) Appropriate reduction of clinical risk factors e.g. hypercholesterolaemia, hypertension and diabetes.
2) Lifestyle change of behavioural risk factors (smoking, nutrition, alcohol, physical activity, weight management).
3) Encouraging compliance with pharmacological management.
4) Management of psychological and social issues, particularly depression.
Consistent with the self- and co-management approach underpinning the care management intervention, patients will be encouraged to follow-up relevant issues with their health provider(s), supported by appropriate ‘hard copy’ or electronic communication being sent to the patient’s doctor by the care manager and co-signed by one of team’s 3 research cardiologists.
Subjects in the intervention group will receive the telephone-based care management program in addition to usual care.
Intervention code [1] 2270 0
Rehabilitation
Comparator / control treatment
Subjects in the control group will receive no other intervention beyond the usual care provided by their usual medical and other health professionals. This may include follow up outpatient department visits, referral to cardiac rehabilitation and ongoing medical management by their General Practitioner (GP).
Control group
Active

Outcomes
Primary outcome [1] 3547 0
Level of physical activity, nutrition and diet as measured by self-report questionnaires.
Timepoint [1] 3547 0
12 months
Secondary outcome [1] 5937 0
Quality of life measured by self report questionnaire.
Timepoint [1] 5937 0
12 months.

Eligibility
Key inclusion criteria
Patients admitted to hospital with acute myocardial infarction.
Minimum age
21 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give informed consent; difficulty in understanding English; participation in other significant research trials; awaiting surgical intervention.

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)
Subjects will be approached in hospital to provide informed consent. Allocation concealment will be by way of opaque sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table generated by compter software.
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
1/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
333
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2781 0
Government body
Name [1] 2781 0
National Health and Medical Research Council (NHMRC)
Country [1] 2781 0
Australia
Primary sponsor type
University
Name
Monash University
Address
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] 2513 0
Hospital
Name [1] 2513 0
Royal Brisbane & Women's Hospital
Address [1] 2513 0
Cnr Butterfield St and Bowen Bridge Rd
Herston QLD 4029
Country [1] 2513 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4701 0
Monash University Human Ethics Research Committee
Ethics committee address [1] 4701 0
Human Ethics Research Committee
Research Office
Building 3E
Monash University VIC 3800
Ethics committee country [1] 4701 0
Australia
Date submitted for ethics approval [1] 4701 0
Approval date [1] 4701 0
25/06/2007
Ethics approval number [1] 4701 0
2007/0584MC

Summary
Brief summary
This study aims to implement and evaluate the impact of a telephone-based care management program, delivered by a care manager, on physical activity and nutrition behaviours and quality of life of people following a heart attack.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28173 0
Address 28173 0
Country 28173 0
Phone 28173 0
Fax 28173 0
Email 28173 0
Contact person for public queries
Name 11330 0
Professor Brian Oldenburg
Address 11330 0
Department of Epidemiology and Preventive Medicine
Monash University
Alfred Hospital Campus
Level 3 (Burnet Tower)
89 Commercial Road
Melbourne VIC 3004
Country 11330 0
Australia
Phone 11330 0
+61 3 99030046
Fax 11330 0
Email 11330 0
[email protected]
Contact person for scientific queries
Name 2258 0
Professor Brian Oldenburg
Address 2258 0
Department of Epidemiology and Preventive Medicine
Monash University
Alfred Hospital Campus
Level 3 (Burnet Tower)
89 Commercial Road
Melbourne VIC 3004
Country 2258 0
Australia
Phone 2258 0
+61 3 99030046
Fax 2258 0
Email 2258 0
[email protected]

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.