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

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ClinicalTrials.gov Identifier: NCT01826929
Recruitment Status : Unknown
Verified April 2013 by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana.
Recruitment status was:  Recruiting
First Posted : April 9, 2013
Last Update Posted : April 10, 2013
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Ischemic Heart Disease Other: Therapeutic education

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : January 2013
Estimated Primary Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline Number of hospitalizations/cause at 12 months [ Time Frame: Baseline and 12 months ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Change from baseline Number of annual primary care visits [ Time Frame: Baseline and 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:

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 ( Other Grant/Funding Number: Valencia Regional Ministry of Health )
First Posted: April 9, 2013    Key Record Dates
Last Update Posted: April 10, 2013
Last Verified: April 2013

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
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases