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

Primary Purpose

Hypercholesterolemia, Cardiovascular Risk

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Share decision tool
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypercholesterolemia focused on measuring cardiovascular diseases, patient education, primary health care, consumer participation, decision aids

Eligibility Criteria

14 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Capse-Gesclínic
  • Cap El Castell

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

Usual care

Intervention arm using a share-decision tool for cardiovascular patients

Outcomes

Primary Outcome Measures

Cardiovascular risk reduction
Cardiovascular risk reduction measured throught REGICOR Spanish scale

Secondary Outcome Measures

Life self-perceived quality
Throught questionnaire SF-12
Anxiety and depression
Throught HADS scale
Decision empowerment
Otawa's decision scale

Full Information

First Posted
March 2, 2011
Last Updated
March 2, 2011
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Preventive Services and Health Promotion Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT01308866
Brief Title
Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients
Acronym
PLEGATS
Official Title
Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Preventive Services and Health Promotion Research Network

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Cardiovascular Risk
Keywords
cardiovascular diseases, patient education, primary health care, consumer participation, decision aids

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
298 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention arm using a share-decision tool for cardiovascular patients
Intervention Type
Behavioral
Intervention Name(s)
Share decision tool
Primary Outcome Measure Information:
Title
Cardiovascular risk reduction
Description
Cardiovascular risk reduction measured throught REGICOR Spanish scale
Time Frame
one year
Secondary Outcome Measure Information:
Title
Life self-perceived quality
Description
Throught questionnaire SF-12
Time Frame
one year
Title
Anxiety and depression
Description
Throught HADS scale
Time Frame
one year
Title
Decision empowerment
Description
Otawa's decision scale
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Gene-Badia, MD, PhD
Organizational Affiliation
University of Barcelona, CAPSE, Health Policy Monitor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patricia Fernandez-Vandellos, RN, MpH
Organizational Affiliation
University of Barcelona
Official's Role
Study Chair
Facility Information:
Facility Name
Capse-Gesclínic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Cap El Castell
City
Castelldefels
ZIP/Postal Code
08860
Country
Spain

12. IPD Sharing Statement

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

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