Effectiveness of a New Health Care Organization Model in Primary Care for Chronic Cardiovascular Disease Patients Based on a Multifactorial Intervention: The PROPRESE Randomized Controlled Trial.

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana0 sites300 target enrollmentJanuary 2013

ConditionsIschemic Heart Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ischemic Heart Disease
Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Enrollment: 300
Primary Endpoint: Change from baseline Number of hospitalizations/cause at 12 months
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether a multifactorial primary care intervention based on chronic models can improve the level of control and reduce the number of hospital admissions in patients with ischemic heart disease.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

January 2014

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•patients with a diagnosis of IHD of any site (ICD-10 codes from 410 to 414 inclusive.
•signed written informed consent

Exclusion Criteria

•lack of consent
•immobilized patients
•patients with serious health problems or with a low life expectancy

Outcomes

Primary Outcomes

Change from baseline Number of hospitalizations/cause at 12 months

Time Frame: Baseline and 12 months

Secondary Outcomes

Change from baseline Blood pressure(Baseline, 4 months, 8 months and 12 months.)
Change from baseline Body Mass Index(Baseline, 4 months, 8 months and 12 months)
Change from baseline Basal Blood Glucose(Baseline, 4 months, 8 months and 12 months)
Change from baseline Healthy Life Habits (exercise, mediterranean diet)(Baseline, 4 months, 8 months and 12 months)
Change from baseline LDL cholesterol(Baseline, 4 months, 8 months and 12 months.)
Change from baseline Number of annual primary care visits(Baseline and 12 months)