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

U

University Hospital, Lille

Status

Completed

Conditions

High Blood Pressure

Treatments

Other: Therapeutic education HTA Vasc

Study type

Interventional

Funder types

Other

Identifiers

NCT01622400
2010-34
2011-A00333-38 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

240 participants in 2 patient groups

Therapeutic education HTA Vasc
Experimental group
Description:
125 subjects who participate in the therapeutic education program
Treatment:
Other: Therapeutic education HTA Vasc
Control group
No Intervention group
Description:
125 subjects who don't participate in the therapeutic education program

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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