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

April 9, 2013 updated by: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Domingo Orozco-Beltran

Study Locations

  • Spain
      • Castellon, Spain
        • Recruiting
        • Sub-Investigator:
          • Enrique Soler-Bahilo
      • Valencia, Spain
        • Recruiting
        • Sub-Investigator:
          • Jorge Navarro-Perez
    • Alicante
      • San Juan de Alicante, Alicante, Spain
        • Recruiting
        • Contact:
        • Principal Investigator:
          • Domingo Orozco-Beltran

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

March 25, 2013

First Submitted That Met QC Criteria

April 4, 2013

First Posted (Estimate)

April 9, 2013

Study Record Updates

Last Update Posted (Estimate)

April 10, 2013

Last Update Submitted That Met QC Criteria

April 9, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USI-10-66
  • SM I 14/2010 (Other Grant/Funding Number: Valencia Regional Ministry of Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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