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Trial registered on ANZCTR


Registration number
ACTRN12606000371594
Ethics application status
Approved
Date submitted
19/08/2006
Date registered
25/08/2006
Date last updated
3/03/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Take Heart in Primary Care Study
Scientific title
A cluster randomised controlled trial designed to investigate the impact on the prevalence and severity of depression, in patients with chronic manifestations of ischaemic heart disease.
Secondary ID [1] 302 0
National Health and Medical Research Council (NHMRC): 361324
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic ischaemic heart disease 1339 0
Comorbid depression 1340 0
Condition category
Condition code
Cardiovascular 1427 1427 0 0
Other cardiovascular diseases
Mental Health 1428 1428 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A comprehensive three-part program of: 1)screening for depression in primary care patients requiring ongoing management of chronic manifestations of ischaemic heart disease; 2) academic detailing of best-practice guidelines for managing depression; and 3) patient-specific psychiatric advice to the treating GP with follow-up screening and advice, relative to usual GP management.
Duration of study: 12 months.
Depression will be determined via the Centre for Epidemiologic Studies-Depression Scale (CES-D) and the Arroll (2 question) scale.
All study patients will be screened at baseline and 12 months. Patients in the intervention group, and depressed, will be rescreened at 3, 6 and 9 months as required.
Intervention code [1] 1317 0
Diagnosis / Prognosis
Comparator / control treatment
No comparator.
Control group
Active

Outcomes
Primary outcome [1] 1953 0
Proportion of surviving patients with chronic manifestations of ischaemic heart disease who are depressed
Timepoint [1] 1953 0
At the completion of 12 months follow-up
Primary outcome [2] 1954 0
A major, and related outcome, is the proportion of patients with mild versus moderate to severe depression and the proportion of initially non depressed patients who display depressive symptoms
Timepoint [2] 1954 0
At 12 months
Secondary outcome [1] 3420 0
1) Prevalence, severity and natural history of depression in a patient cohort being treated for chronic manifestations of ischaemic heart disease in primary care.
Timepoint [1] 3420 0
Examined at baseline, 3,6,9 and 12 months and data will be collated and assessed at the completion of 12 months.
Secondary outcome [2] 3421 0
2) Effects of a pragmatic GP focussed screening and intervention program on the severity of depression, and effects on the overall management of chronic manifestations of ischaemic heart disease, risk factor profile, angina pectoris (AP) and heart failure (HF) specific clinical health outcomes, patient wellbeing and quality of life, treatment adherence patterns, and morbidity and mortality.
Timepoint [2] 3421 0
At 12 months.
Secondary outcome [3] 3422 0
3) Health related quality of life will be reassessed via the SF-12 and EQ-5D, the latter measure providing utility scores and quality adjusted life years (QALYs) for a cost utility analysis.
Timepoint [3] 3422 0
At 12 months followup.

Eligibility
Key inclusion criteria
(GPs):All South Australian urban and urban fringe general practices,computerised, minimum of three full-time equivalent GPs, general practice nurse, offering physical space for screening.Inclusion criteria (patients):a diagnosis of ischaemic heart disease in the preceeding 6 months and requiring ongoing management for manifestations of ischaemic heart disease, particularly angina pectoris and/or heart failure, must attend the practice, speak and understand english, have intact cognitive function and be willing to provide informed consent.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(Patients):a psychotic illness or communication deficit precluding communication with the GP, planned correction of underlying cardiovascular disease state (eg coronary artery bypass grafting or heart transplant) or acute hospital admission for any cardiovacular reason in past 3 months.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation organised and maintained centrally by colleague not directly involved with running of study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation. Unit of randomisation:general practice. Stratified by GP division. Random numbers generated by computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
604
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1559 0
Government body
Name [1] 1559 0
National Health and Medical Research Council
Country [1] 1559 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
Country
Australia
Secondary sponsor category [1] 1372 0
University
Name [1] 1372 0
The University of Queensland
Address [1] 1372 0
Herston Road, Brisbane. QLD 4066
Country [1] 1372 0
Australia
Other collaborator category [1] 220 0
University
Name [1] 220 0
University of Adelaide
Address [1] 220 0
North Terrace, Adelaide. SA 5000
Country [1] 220 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2991 0
The University of Queensland
Ethics committee address [1] 2991 0
Ethics committee country [1] 2991 0
Australia
Date submitted for ethics approval [1] 2991 0
Approval date [1] 2991 0
19/05/2006
Ethics approval number [1] 2991 0
2006000270
Ethics committee name [2] 5128 0
The University of Adelaide
Ethics committee address [2] 5128 0
Ethics committee country [2] 5128 0
Australia
Date submitted for ethics approval [2] 5128 0
Approval date [2] 5128 0
24/10/2006
Ethics approval number [2] 5128 0
H-126-2006

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

Contacts
Principal investigator
Name 27924 0
Address 27924 0
Country 27924 0
Phone 27924 0
Fax 27924 0
Email 27924 0
Contact person for public queries
Name 10506 0
Kerena Eckert, Postdoctoral Research Fellow
Address 10506 0
School of Medicine
University of Queensland
Herston Road, Herston QLD 4006
Country 10506 0
Australia
Phone 10506 0
0405 182 391
Fax 10506 0
61 8 8222 6025
Email 10506 0
kerena.eckert@adelaide.edu.au
Contact person for scientific queries
Name 1434 0
Professor Simon Stewart
Address 1434 0
Baker Heart Research Institute
PO Box 6492
St Kilda Road, Central 8008
Country 1434 0
Australia
Phone 1434 0
61 3 9276 2903
Fax 1434 0
61 3 9251 1837
Email 1434 0
simon.stewart@baker.edu.au

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.