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Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients

NCT01308866 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 298

Last updated 2011-03-04

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Share decision tool

Sponsors & Collaborators

  • Preventive Services and Health Promotion Research Network

    collaborator OTHER

  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    lead OTHER

Principal Investigators

  • Joan Gene-Badia, MD, PhD · University of Barcelona, CAPSE, Health Policy Monitor

  • Patricia Fernandez-Vandellos, RN, MpH · University of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2010-09-30
Completion
2011-03-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01308866 on ClinicalTrials.gov