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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Other: Therapeutic education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic education<br>Organized intervention strategy:Informed active patient, shared decision making, appointment planning, primary care doctor-nurse teamwork, actions based on scientific evidence. | Other: Therapeutic education<br> <br> |
| No Intervention: Usual care model<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Number of hospitalizations/cause at 12 months |  | Baseline and 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health Services Research, Cardiovascular Diseases, Primary Care, Secondary Prevention.