Text Size

Efficacy of a Dedicated Therapeutic Education Program in Patients at High Cardiovascular Risk

This study is currently recruiting participants.
Verified September 2011 by University Hospital, Lille
Sponsor:
Collaborators:
Association HTA Vasc
CRESGE (Centre de Recherches Economiques Sociologiques et de Gestion)
CERIM (Centre d'Etudes et de Recherche en Informatique Médicale), P. Devos
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01622400
First received: October 24, 2011
Last updated: June 14, 2012
Last verified: September 2011
History of Changes
  Purpose

A dedicated therapeutic education program is an essential tool in the management of hypertension as well as in the control of other cardiovascular risk factors. The purpose of this study is therefore to evaluate the effect of such a therapeutic education program in general practice patients at high cardiovascular risk.


Condition Intervention
High Blood Pressure
 Other: Program of therapeutic education HTA Vasc

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Prospective Trial Evaluating the Efficacy of a Dedicated Therapeutic Education Program on the Blood Pressure and Other Cardiovascular Risk Factors Control in General Practice Patients at High Cardiovascular Risk

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • High Blood Pressure in 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentage of patients with a blood pressure of 130/80 mmHg or less in 12 months


Secondary Outcome Measures:
  • High Blood pressure at 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Percentage of patients with a blood pressure of 130/80 mmHg or less in 24 months


Estimated Enrollment: 250
Study Start Date: September 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Therapeutic education group
125 subjects who participate in the therapeutic education program
 Other: Program of therapeutic education HTA Vasc
The intervention program takes place in 3 phases. First, the education team realizes an individual educational diagnosis to define the objectives of the intervention according to each patient's needs. Secondly, patients assist to 3 to 5 group sessions lasting 2 hours with a dedicated nurse focusing on medical therapy explanation and blood pressure self measurement education - and with a dedicated nutritionist focusing on stress management and nutrition program. Patients can also have individual consultations with the dedicated nutritionist. Finally, an individual assessment permits to evaluate the benefits of the program for each patient and to define new objectives.
Other Name: Program proposed by the association HTA Vasc
No Intervention: Control group
125 subjects who don't participate in the therapeutic education program

Detailed Description:

Current guidelines for the prevention of cardiovascular disease recognize the major interest of an optimal control of all cardiovascular risk factors. It includes high blood pressure reduction, dietetic measures (weight loss - control of dyslipidemia and diabetes - regular physical activity), smoking cessation, stress management, … In that way, some authors suggest that it is essential for patients at high risk to have knowledge about their own pathology, medication, and to better understand the real benefit of specific lifestyle behaviors and the importance of blood pressure and glycaemia surveillance … The aim of this randomized controlled trial is to evaluate the efficacy of a dedicated therapeutic education program to control blood pressure and other cardiovascular risk factors in general practice patients at high cardiovascular risk.

250 patients are being enrolled. All patients will receive standard care but only 125 patients (randomized 1 to 1) will receive a structured therapeutic education program.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Man or woman of more than 18 years with a health insurance policy
  • General practice patients who are agree to participate of the program of patient's therapeutic education in Lille (59) or Arras (62)
  • Written informed consent must be obtained prior to performing any study-specific procedures
  • Patient at high cardiovascular risk (Patient with a high blood pressure and 3 cardiovascular risk factors and/or Patient with cardiovascular disease)

Exclusion Criteria:

  • Patient unwilling to take part to the therapeutic education program or to the study
  • Patient not suitable to participate in the therapeutic education program
  • Patient with dementia
  • Anticipated survival (due to comorbidities) of less than one year from baseline
  • Patient with current addiction or current alcohol / drug abuse
  • Patient with known plans to move to another area of the country
  • Unable to obtain written informed consent
  • Patient who are pregnant or lactating
  • Person without liberty by administrative or judiciary decision
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01622400

Contacts
Contact: MOUNIER-VEHIER Claire, Cardiologist 33320444036 claire.mounier-vehier@chru-lille.fr

Locations
France
General Practice Office Recruiting
Arras, France
Contact: MOUNIER-VEHIER Claire, Cardiologist     33320444036     claire.mounier-vehier@chru-lille.fr    
Principal Investigator: FAYOLLE Patrick, GP            
General practice office Recruiting
Lille, France
Contact: MOUNIER-VEHIER Claire, Cardiologist     33320444036     claire.mounier-vehier@chru-lille.fr    
Principal Investigator: GOUDJI Gustave, GP            
Sponsors and Collaborators
University Hospital, Lille
Association HTA Vasc
CRESGE (Centre de Recherches Economiques Sociologiques et de Gestion)
CERIM (Centre d'Etudes et de Recherche en Informatique Médicale), P. Devos
Investigators
Principal Investigator: FAYOLLE PF Patrick, GP Arras Principal Investigator
Principal Investigator: GOUDJI GG Gustave, GP Lille Principal Investigator
  More Information

No publications provided

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01622400     History of Changes
Other Study ID Numbers: 2011-A00333-38, 2011-A00333-38, 2010-34
Study First Received: October 24, 2011
Last Updated: June 14, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: National Consultative Ethics Committee for Health and Life Sciences

Keywords provided by University Hospital, Lille:
Cardiovascular risk, Therapeutic education, General practice

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013