Effects of patient-centered modular secondary prevention in people with acute coronary syndrome

ISRCTN ISRCTN42984084
DOI https://doi.org/10.1186/ISRCTN42984084
Secondary identifying numbers G03S1204
Submission date
24/01/2006
Registration date
24/01/2006
Last edited
02/11/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Julie Hila
Scientific

10/1-3 Funda Pl
Brookvale
Sydney NSW
2100
Australia

Study information

Study designSingle blinded, randomised controlled trial with three groups
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleEffects of patient-centered modular secondary prevention in people with acute coronary syndrome
Study objectivesThis study aims to test the effect of modular secondary prevention on total blood cholesterol, heart disease risk factors and knowledge in persons who have had an acute coronary syndrome.
Ethics approval(s)Approved by the Central Sydney Area Health Services Human Research and Ethics Committee (CRGH) on 21st May 2003 (ref: CH/62/6/2003-021).
Health condition(s) or problem(s) studiedCoronary heart disease and acute coronary syndrome
InterventionIntervention group will participate in modular prevention including individual risk factor assessment, goal setting and coaching. Control group will continue conventional care by their general practitioner. The standard cardiac rehabilitation group will participate in hospital-based cardiac rehabilitation including six weeks of group exercise and education.
Intervention typeOther
Primary outcome measureProportion of participants with total blood cholesterol less than 4.5 mmol/l.
Secondary outcome measuresProportion of participants achieving nationally recommended targets for heart disease risk factors, absolute heart disease risk on the lipid risk score and risk factor knowledge
Overall study start date01/01/2004
Completion date01/07/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants208
Total final enrolment144
Key inclusion criteria1. Acute coronary syndrome within 12 months of assessment
2. Refusal of invitation to participate in cardiac rehabilitation
Key exclusion criteriaDiagnosis of uncontrolled cardiomyopathy, aortic stenosis, arrhythmia, dementia or a terminal illness such as end-stage renal failure
Date of first enrolment01/01/2004
Date of final enrolment01/07/2006

Locations

Countries of recruitment

  • Australia

Study participating centre

10/1-3 Funda Pl
Sydney NSW
2100
Australia

Sponsor information

National Heart Foundation of Australia
Charity

Research Division
411 King Street
West Melbourne VIC
3003
Australia

Website http://www.heartfoundation.com.au
ROR logo "ROR" https://ror.org/039d9wr27

Funders

Funder type

Charity

National Heart Foundation of Australia Grant-in-Aid (G03S1204) and a Postgraduate Clinical Research Scholarship for Julie Hila (PC03S1258).

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article 09/06/2006 Yes No
Results article 01/03/2009 Yes No

Editorial Notes

02/11/2022: Total final enrolment added.