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

Primary Purpose

Ischemic Heart Disease

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Therapeutic education
Sponsored by
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Ischemic Heart Disease focused on measuring Health Services Research, Cardiovascular Diseases, Primary Care, Secondary Prevention.

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Recruiting
  • Recruiting
  • Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Therapeutic education

Usual care model

Arm Description

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

Outcomes

Primary Outcome Measures

Change from baseline Number of hospitalizations/cause at 12 months

Secondary Outcome Measures

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.
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.
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.
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.
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.
Change from baseline Number of annual primary care visits

Full Information

First Posted
March 25, 2013
Last Updated
April 9, 2013
Sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
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1. Study Identification

Unique Protocol Identification Number
NCT01826929
Brief Title
Effectiveness New Health Care Organization Model in Primary Care for Chronic Cardiovascular Disease Patients Based
Acronym
PROPRESE
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

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
Keywords
Health Services Research, Cardiovascular Diseases, Primary Care, Secondary Prevention.

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic education
Arm Type
Experimental
Arm Description
Organized intervention strategy:Informed active patient, shared decision making, appointment planning, primary care doctor-nurse teamwork, actions based on scientific evidence.
Arm Title
Usual care model
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Therapeutic education
Primary Outcome Measure Information:
Title
Change from baseline Number of hospitalizations/cause at 12 months
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Change from baseline Blood pressure
Description
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.
Time Frame
Baseline, 4 months, 8 months and 12 months.
Title
Change from baseline LDL cholesterol
Description
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.
Time Frame
Baseline, 4 months, 8 months and 12 months.
Title
Change from baseline Body Mass Index
Description
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.
Time Frame
Baseline, 4 months, 8 months and 12 months
Title
Change from baseline Basal Blood Glucose
Description
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.
Time Frame
Baseline, 4 months, 8 months and 12 months
Title
Change from baseline Healthy Life Habits (exercise, mediterranean diet)
Description
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.
Time Frame
Baseline, 4 months, 8 months and 12 months
Title
Change from baseline Number of annual primary care visits
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Domingo Orozco-Beltran
Phone
0034 965919309
Email
dorozcobeltran@hotmai.com
Facility Information:
City
San Juan de Alicante
State/Province
Alicante
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Domingo Orozco-Beltran
Phone
0034965919309
Email
dorozcobeltran@gmail.com
First Name & Middle Initial & Last Name & Degree
Domingo Orozco-Beltran
City
Castellon
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrique Soler-Bahilo
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Navarro-Perez

12. IPD Sharing Statement

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

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