Randomised controlled trial to assess the efficacy of a comprehensive secondary prevention programme in primary care
| ISRCTN | ISRCTN18578323 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18578323 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/03/2005
- Registration date
- 04/04/2005
- Last edited
- 14/04/2008
- 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
Dr Carlos Brotons
Scientific
Scientific
Unit of Research
Sardenya Primary Health Care Center
Sardenya 466
Barcelona
08025
Spain
| Phone | +34 935 67 43 80 |
|---|---|
| cbrotons@eapsardenya.net |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | |
| Study acronym | PREseAP |
| Study objectives | A comprehensive programme on secondary prevention of cardiovascular diseases in primary care reduces rehospitalisation and mortality, and improves quality of life. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular disease |
| Intervention | Health Centres (clusters) are randomised to intervention or control group. Intervention group (comprehensive programme in secondary prevention led by well-trained registered nurses): Patient education and counselling, optimisation of the treatments according to CVD prevention guidelines (drugs, diet, exercise). The number of scheduled visits will be 9 (every 4 months). Control group: Patients in the control group will be assigned to conventional care. Number of visits: two (baseline assessmenta and final visit at the end of the trial). Follow-up period: 3 years Endpoints: combined of cardiovascular disease mortality and cardiovascular disease morbidity (including revascularisation) |
| Intervention type | Other |
| Primary outcome measure | 1. Combination of total mortality 2. Cardiovascular fatal events 3. Cardiovascular non-fatal events |
| Secondary outcome measures | 1. Total mortality 2. Cardiovascular fatal events 3. Cardiovascular non-fatal events 4. Quality of life measured with the 36-item short form health survey (SF-36) instrument |
| Overall study start date | 01/01/2005 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 2100 |
| Key inclusion criteria | Patients are recruited from 42 primary health care centres from eight different regions of Spain (2100 patients are expected to be recruited). Inclusion Criteria: Males and females below 86 years, diagnosed with coronary heart disease (CHD), stroke or peripheral vascular disease in the last year. |
| Key exclusion criteria | 1. Patients diagnosed with cardiovascular disease (CVD) before the year 2004 2. Unstable patients (post myocardial infarction [MI] angina of less than 28 days after discharge, ventricular arrhythmias in the last six months) 3. Subarachnoid haemorrhage, cerebral embolisms secondary to valve disease 4. Patients with concomitant serious chronic disease (cancer, chronic renal failure, etc.) 5. Patients with poor mental function or any other reason to expect that the patient may have difficulty in complying with the requirements of the study |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Spain
Study participating centre
Unit of Research
Barcelona
08025
Spain
08025
Spain
Sponsor information
Sardenya Primary Care Center (in collaboration with the Catalan Foundation Institute of Pharmacology) (Spain)
Hospital/treatment centre
Hospital/treatment centre
Sardenya 466
Barcelona
08025
Spain
| Phone | +34 935 67 43 80 |
|---|---|
| cbrotons@eapsardenya.net |
Funders
Funder type
Hospital/treatment centre
Carlos III Health Institute of the Spanish Ministry of Health and Consumption (Fondo de Investigaciones Sanitarias - Instituto de Salud Carlos III-Ministerio de Sanidad y Consumo) (Spain) (ref: PI031421)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/03/2008 | Yes | No |
