Clinical trial NCT01826929: Effectiveness New Health Care Organization Model in Primary Care for Chronic Cardiovascular Disease Patients Based
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Heart Disease
Keywords: Health Services Research
Cardiovascular Diseases
Primary Care
Secondary Prevention.
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2013-04-09
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Change from baseline Number of hospitalizations/cause at 12 months
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change from baseline Blood pressure
timeFrame: Baseline, 4 months, 8 months and 12 months.
measure: Change from baseline LDL cholesterol
timeFrame: Baseline, 4 months, 8 months and 12 months.
measure: Change from baseline Body Mass Index
timeFrame: Baseline, 4 months, 8 months and 12 months
measure: Change from baseline Basal Blood Glucose
timeFrame: Baseline, 4 months, 8 months and 12 months
measure: Change from baseline Healthy Life Habits (exercise, mediterranean diet)
timeFrame: Baseline, 4 months, 8 months and 12 months
measure: Change from baseline Number of annual primary care visits
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: San Juan de Alicante
country: Spain
state: Alicante
city: Castellon
country: Spain
city: Valencia
country: Spain
Study officials:
References:
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