- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01622400
Efficacy of a Dedicated Therapeutic Education Program in Patients at High Cardiovascular Risk
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Arras, France
- General practice office
-
Lille, France
- General practice office
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Therapeutic education HTA Vasc
125 subjects who participate in the therapeutic education program
|
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:
|
NO_INTERVENTION: Control group
125 subjects who don't participate in the therapeutic education program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: FAYOLLE PF Patrick, GP, Arras Principal Investigator
- Principal Investigator: GOUDJI GG Gustave, GP, Lille Principal Investigator
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-34
- 2011-A00333-38 (OTHER: ID-RCB number, ANSM)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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