Clinical trial NCT01308866: Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients
Official title: Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Cardiovascular Risk
Keywords: cardiovascular diseases
patient education
primary health care
consumer participation
decision aids
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Preventive Services and Health Promotion Research Network
First posted: 2011-03-04
Enrollment: 298
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Cardiovascular risk reduction
timeFrame: one year
Secondary outcomes:
measure: Life self-perceived quality
timeFrame: one year
measure: Anxiety and depression
timeFrame: one year
measure: Decision empowerment
timeFrame: one year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Capse-Gesclínic
city: Castelldefels
country: Spain
facility: Cap El Castell
Study officials:
affiliation: University of Barcelona, CAPSE, Health Policy Monitor
name: Joan Gene-Badia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Barcelona
name: Patricia Fernandez-Vandellos, RN, MpH
role: STUDY_CHAIR
References: