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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01308866
Acronym
PLEGATS
Enrollment
298
Registered
2011-03-04
Start date
2007-07-31
Completion date
2011-03-31
Last updated
2011-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk, Hypercholesterolemia

Keywords

cardiovascular diseases, patient education, primary health care, consumer participation, decision aids

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.

Interventions

BEHAVIORALShare decision tool

Sponsors

Preventive Services and Health Promotion Research Network
CollaboratorOTHER
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiovascular risk reductionone yearCardiovascular risk reduction measured throught REGICOR Spanish scale

Secondary

MeasureTime frameDescription
Life self-perceived qualityone yearThrought questionnaire SF-12
Anxiety and depressionone yearThrought HADS scale
Decision empowermentone yearOtawa's decision scale

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026