PLEGATS: Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients
Study Details
Study Description
Brief Summary
BACKGROUND: Mediterraneans have traditionally a low cardiovascular risk, although emerging lifestyles might change the trend. The aim of this study is to assess if hypercholesterolemic patient involvement in the preventive decision with the help of a decision aid has an impact on cardiovascular (CV) risk reduction superior to usual care.
METHOD: The design is a cluster randomised clinical trial. Participants are hypercholesterolemic patients (>200 mg/dl or c-LDL>130) from four primary care teams of Barcelona. Patients with previous CV events, age over 75 years or cognitive impairment are excluded. It is expected to create two cohorts of 139 patients each one. The randomisation is by doctor. Intervention group will receive information about their CV risk and the risk and benefits of different preventive measures. They will have access to a decission aid that will help them in the choice of the preventive measures.The material (printed and software) is adapted to the Catalan Population using local CV risk tables and will meet the CREDIBLE and DISCERN criteria. STUDY VARIABLES: Sociodemographic variables, CV risk factors, subjective health (SF 12), decisional conflict, anxiety/depression, analytic controls, treatment, treatment adherence, compliance and resources use. Basal evaluation and 3, 6, 12 month assessment. The study, financed by FIS, will begin the 01-07-2007.
RESULTS: The expected results are a higher reduction on the CV risk factors in the intervention group versus regular care.
CONCLUSIONS Study will provide a tool to be used in Spanish and Catalan population.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control Usual care |
|
| Experimental: Intervention Intervention arm using a share-decision tool for cardiovascular patients |
Behavioral: Share decision tool
|
Outcome Measures
Primary Outcome Measures
- Cardiovascular risk reduction [one year]
Cardiovascular risk reduction measured throught REGICOR Spanish scale
Secondary Outcome Measures
- Life self-perceived quality [one year]
Throught questionnaire SF-12
- Anxiety and depression [one year]
Throught HADS scale
- Decision empowerment [one year]
Otawa's decision scale
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients between 14 and 75 years old having the inclusion criteria and consulting for cardiovascular risk diseases (CVD) in these centers.
-
Patients who allow to participate in this study
Exclusion Criteria:
-
Patients with mental disorders.
-
Secundary cardiovascular risk patients
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Capse-Gesclínic | Barcelona | Spain | 08036 | |
| 2 | Cap El Castell | Castelldefels | Spain | 08860 |
Sponsors and Collaborators
- Jordi Gol i Gurina Foundation
- Preventive Services and Health Promotion Research Network
Investigators
- Principal Investigator: Joan Gene-Badia, MD, PhD, University of Barcelona, CAPSE, Health Policy Monitor
- Study Chair: Patricia Fernandez-Vandellos, RN, MpH, University of Barcelona
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PLEGATS