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ISRCTN
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ISRCTN18578323
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial to assess the efficacy of a comprehensive secondary prevention programme in primary care
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Scientific title
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Acronym
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PREseAP
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Serial number at source
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N/A
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Study hypothesis
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A comprehensive programme on secondary prevention of cardiovascular diseases in primary care reduces rehospitalisation and mortality, and improves quality of life.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Spain
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Disease/condition/study domain
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Cardiovascular disease
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/2005
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Anticipated end date
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31/12/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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2100
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Interventions
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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)
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Primary outcome measure(s)
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1. Combination of total mortality
2. Cardiovascular fatal events
3. Cardiovascular non-fatal events
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Secondary outcome measure(s)
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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
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Sources of funding
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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)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18361907
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Contact name
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Dr
Carlos
Brotons
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Address
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Unit of Research
Sardenya Primary Health Care Center
Sardenya 466
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City/town
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Barcelona
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Zip/Postcode
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08025
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Country
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Spain
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Tel
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+34 935 67 43 80
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Fax
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+34 935 67 43 81
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Email
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cbrotons@eapsardenya.net
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Sponsor
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Sardenya Primary Care Center (in collaboration with the Catalan Foundation Institute of Pharmacology) (Spain)
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Address
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Sardenya 466
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City/town
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Barcelona
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Zip/Postcode
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08025
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Country
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Spain
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Tel
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+34 935 67 43 80
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Fax
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+34 935 67 43 81
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Email
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cbrotons@eapsardenya.net
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Date applied
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08/03/2005
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Last edited
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14/04/2008
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Date ISRCTN assigned
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04/04/2005
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