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

March 25, 2013
April 9, 2013
January 2013
January 2014   (final data collection date for primary outcome measure)
Change from baseline Number of hospitalizations/cause at 12 months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01826929 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
  • Chage from baseline Number of annual primary care visits [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effectiveness New Health Care Organization Model in Primary Care for Chronic Cardiovascular Disease Patients Based
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Ischemic Heart Disease
Other: Therapeutic education
  • Experimental: Therapeutic education
    Organized intervention strategy:Informed active patient, shared decision making, appointment planning, primary care doctor-nurse teamwork, actions based on scientific evidence.
    Intervention: Other: Therapeutic education
  • No Intervention: Usual care model

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Not Provided
January 2014   (final data collection date for primary outcome measure)

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
Both
30 Years to 80 Years
No
Contact: Domingo Orozco-Beltran 0034 965919309 dorozcobeltran@hotmai.com
Spain
 
NCT01826929
USI-10-66, SM I 14/2010
No
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Not Provided
Not Provided
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP