NCT01622400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2011

Completed
8 months until next milestone

First Posted

Study publicly available on registry

June 19, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

4.6 years

First QC Date

October 24, 2011

Last Update Submit

June 18, 2018

Conditions

High Blood Pressure

Keywords

Cardiovascular risk, Therapeutic education, General practice

Outcome Measures

Primary Outcomes (1)

  • High Blood Pressure in 12 months

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

    12 months

Secondary Outcomes (1)

  • High Blood pressure at 24 months

    24 months

Study Arms (2)

Therapeutic education HTA Vasc

EXPERIMENTAL

125 subjects who participate in the therapeutic education program

Other: Therapeutic education HTA Vasc

Control group

NO INTERVENTION

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

Interventions

Therapeutic education HTA VascOTHER

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.

Also known as: Program proposed by the association HTA Vasc
Therapeutic education HTA Vasc

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

General Practice Office

Arras, France

Location

General practice office

Lille, France

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • FAYOLLE PF Patrick, GP

    Arras Principal Investigator

    PRINCIPAL INVESTIGATOR

  • GOUDJI GG Gustave, GP

    Lille Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2011

First Posted

June 19, 2012

Study Start

September 1, 2011

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

June 20, 2018

Record last verified: 2018-06

Locations

FR(2)