Effectiveness New Health Care Organization Model in Primary Care for Chronic Cardiovascular Disease Patients Based

Not Applicable

• Conditions: Ischemic Heart Disease
• Interventions: Other: Therapeutic education

• Registration Number: NCT01826929
• Lead Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-03-25
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-04
• Study First Posted: 2013-04-09
• Last Update Submitted: 2013-04-09
• Last Update Posted: 2013-04-10
• Primary Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic education	Therapeutic education	Organized intervention strategy:Informed active patient, shared decision making, appointment planning, primary care doctor-nurse teamwork, actions based on scientific evidence.

Primary Outcome Measures

Name	Time	Method
Change from baseline Number of hospitalizations/cause at 12 months	Baseline and 12 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline Blood pressure	Baseline, 4 months, 8 months and 12 months.	It is measured at each visit in order to monitor the evolution. However, the change is calculated as the latest time point minus the earliest time point.
Change from baseline Body Mass Index	Baseline, 4 months, 8 months and 12 months	It is measured at each visit in order to monitor the evolution. However, the change is calculated as the latest time point minus the earliest time point.
Change from baseline Basal Blood Glucose	Baseline, 4 months, 8 months and 12 months	It is measured at each visit in order to monitor the evolution. However, the change is calculated as the latest time point minus the earliest time point.
Change from baseline Healthy Life Habits (exercise, mediterranean diet)	Baseline, 4 months, 8 months and 12 months	It is measured at each visit in order to monitor the evolution. However, the change is calculated as the latest time point minus the earliest time point.
Change from baseline LDL cholesterol	Baseline, 4 months, 8 months and 12 months.	It is measured at each visit in order to monitor the evolution. However, the change is calculated as the latest time point minus the earliest time point.
Change from baseline Number of annual primary care visits	Baseline and 12 months