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

NCT01308866 | Completed DMC

• 1 other identifier: PLEGATS
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypercholesterolemia; Cardiovascular Risk

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cardiovascular risk reduction

  Cardiovascular risk reduction measured throught REGICOR Spanish scale

  one year

Secondary Outcomes (3)

• Life self-perceived quality

  one year

• Anxiety and depression

  one year

• Decision empowerment

  one year

Study Arms (2)

Control

NO INTERVENTION

Usual care

Intervention

EXPERIMENTAL

Intervention arm using a share-decision tool for cardiovascular patients

Behavioral: Share decision tool

Interventions

Share decision tool BEHAVIORAL

Intervention

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who allow to participate in this study

You may not qualify if:

• Patients with mental disorders.
• Secundary cardiovascular risk patients

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Preventive Services and Health Promotion Research Network: collaborator

Study Sites (2)

Capse-Gesclínic

Barcelona, Barcelona, 08036, Spain

Location

Cap El Castell

Castelldefels, 08860, Spain

Location

MeSH Terms

Conditions

Hypercholesterolemia; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Joan Gene-Badia, MD, PhD

  University of Barcelona, CAPSE, Health Policy Monitor

  PRINCIPAL INVESTIGATOR

• Patricia Fernandez-Vandellos, RN, MpH

  University of Barcelona

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 4, 2011
• Study Start: July 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: March 1, 2011
• Last Updated: March 4, 2011

Record last verified: 2011-03

Locations

ES (2)