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

NCT ID: NCT01622400

Last Updated: 2018-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2016-04-30

Brief Summary

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.

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.

Conditions

High Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Therapeutic education HTA Vasc

125 subjects who participate in the therapeutic education program

Group Type: EXPERIMENTAL

Therapeutic education HTA Vasc

Intervention Type: OTHER

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.

Control group

125 subjects who don't participate in the therapeutic education program

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Program proposed by the association HTA Vasc

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Association HTA Vasc

OTHER

Sponsor Role: collaborator

CRESGE (Centre de Recherches Economiques Sociologiques et de Gestion)

UNKNOWN

Sponsor Role: collaborator

CERIM (Centre d'Etudes et de Recherche en Informatique Médicale), P. Devos

UNKNOWN

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

FAYOLLE PF Patrick, GP

Role: PRINCIPAL_INVESTIGATOR

Arras Principal Investigator

GOUDJI GG Gustave, GP

Role: PRINCIPAL_INVESTIGATOR

Lille Principal Investigator

Locations

General Practice Office

Arras, , France

General practice office

Lille, , France

Countries

France

Other Identifiers

2011-A00333-38

Identifier Type: OTHER

Identifier Source: secondary_id

2010-34

Identifier Type: -

Identifier Source: org_study_id