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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor:
Information provided by (Responsible Party):
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
ClinicalTrials.gov Identifier:
NCT01826929
First received: March 25, 2013
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Ischemic Heart Disease
Other: Therapeutic education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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.

Resource links provided by NLM:


Further study details as provided by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana:

Primary Outcome Measures:
  • Change from baseline Number of hospitalizations/cause at 12 months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline Blood pressure [ Time Frame: Baseline, 4 months, 8 months and 12 months. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 4 months, 8 months and 12 months. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 4 months, 8 months and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 4 months, 8 months and 12 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, 4 months, 8 months and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01826929

Contacts
Contact: Domingo Orozco-Beltran 0034 965919309 dorozcobeltran@hotmai.com

Locations
Spain
Recruiting
San Juan de Alicante, Alicante, Spain
Contact: Domingo Orozco-Beltran    0034965919309    dorozcobeltran@gmail.com   
Principal Investigator: Domingo Orozco-Beltran         
Recruiting
Castellon, Spain
Sub-Investigator: Enrique Soler-Bahilo         
Recruiting
Valencia, Spain
Sub-Investigator: Jorge Navarro-Perez         
Sponsors and Collaborators
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
  More Information

Publications:
Graham I, Atar D, Borch-Johnsen K, Boysen G, Burell G, Cifkova R, Dallongeville J, De Backer G, Ebrahim S, Gjelsvik B, Herrmann-Lingen C, Hoes A, Humphries S, Knapton M, Perk J, Priori SG, Pyorala K, Reiner Z, Ruilope L, Sans-Menendez S, Scholte op Reimer W, Weissberg P, Wood D, Yarnell J, Zamorano JL, Walma E, Fitzgerald T, Cooney MT, Dudina A; European Society of Cardiology (ESC) Committee for Practice Guidelines (CPG). European guidelines on cardiovascular disease prevention in clinical practice: executive summary: Fourth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (Constituted by representatives of nine societies and by invited experts). Eur Heart J. 2007 Oct;28(19):2375-414. Epub 2007 Aug 28. No abstract available.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
ClinicalTrials.gov Identifier: NCT01826929     History of Changes
Other Study ID Numbers: USI-10-66, SM I 14/2010
Study First Received: March 25, 2013
Last Updated: April 9, 2013
Health Authority: Spain: Valencia Regional Ministry of Health

Keywords provided by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana:
Health Services Research
Cardiovascular Diseases
Primary Care
Secondary Prevention.

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Coronary Disease
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014