Effects of patient-centered modular secondary prevention in people with acute coronary syndrome
| ISRCTN | ISRCTN42984084 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42984084 |
| Protocol serial number | G03S1204 |
| Sponsor | National Heart Foundation of Australia |
| Funder | National Heart Foundation of Australia Grant-in-Aid (G03S1204) and a Postgraduate Clinical Research Scholarship for Julie Hila (PC03S1258). |
- 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
Scientific
10/1-3 Funda Pl
Brookvale
Sydney NSW
2100
Australia
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single blinded, randomised controlled trial with three groups |
| Secondary study design | Randomised controlled trial |
| Scientific title | Effects of patient-centered modular secondary prevention in people with acute coronary syndrome |
| Study objectives | This 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) studied | Coronary heart disease and acute coronary syndrome |
| Intervention | Intervention 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 type | Other |
| Primary outcome measure(s) |
Proportion of participants with total blood cholesterol less than 4.5 mmol/l. |
| Key secondary outcome measure(s) |
Proportion of participants achieving nationally recommended targets for heart disease risk factors, absolute heart disease risk on the lipid risk score and risk factor knowledge |
| Completion date | 01/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 208 |
| Total final enrolment | 144 |
| Key inclusion criteria | 1. Acute coronary syndrome within 12 months of assessment 2. Refusal of invitation to participate in cardiac rehabilitation |
| Key exclusion criteria | Diagnosis of uncontrolled cardiomyopathy, aortic stenosis, arrhythmia, dementia or a terminal illness such as end-stage renal failure |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 01/07/2006 |
Locations
Countries of recruitment
- Australia
Study participating centre
10/1-3 Funda Pl
Sydney NSW
2100
Australia
2100
Australia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/03/2009 | Yes | No | ||
| Protocol article | 09/06/2006 | Yes | No |
Editorial Notes
02/11/2022: Total final enrolment added.
