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Completed

NCT Number: NCT01622400

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

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.

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Key information

Conditions

High Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Practice Office, Arras, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapeutic education HTA Vasc

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.

Other names: Program proposed by the association HTA Vasc

Primary outcomes

  1. High Blood Pressure in 12 months

    Time frame: 12 months

    Percentage of patients with a blood pressure of 140/90 mmHg or less in 12 months

Secondary outcomes

  1. High Blood pressure at 24 months

    Time frame: 24 months

    Percentage of patients with a blood pressure of 140/90 mmHg or less in 24 months

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Association HTA Vasc
  • CERIM (Centre d'Etudes et de Recherche en Informatique Médicale), P. Devos
  • CRESGE (Centre de Recherches Economiques Sociologiques et de Gestion)

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jun 19, 2012
Registry last updated
Jun 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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