Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients
NCT ID: NCT01308866
Last Updated: 2011-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
298 participants
INTERVENTIONAL
2007-07-31
2011-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control
Usual care
No interventions assigned to this group
Intervention
Intervention arm using a share-decision tool for cardiovascular patients
Share decision tool
Interventions
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Share decision tool
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Secundary cardiovascular risk patients
14 Years
75 Years
ALL
No
Sponsors
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Preventive Services and Health Promotion Research Network
OTHER
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
OTHER
Responsible Party
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University of Barcelona
Principal Investigators
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Joan Gene-Badia, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Barcelona, CAPSE, Health Policy Monitor
Patricia Fernandez-Vandellos, RN, MpH
Role: STUDY_CHAIR
University of Barcelona
Locations
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Capse-Gesclínic
Barcelona, Barcelona, Spain
Cap El Castell
Castelldefels, , Spain
Countries
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Other Identifiers
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PLEGATS
Identifier Type: -
Identifier Source: org_study_id
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