High Blood PressureNCT01622400
Efficacy of a Dedicated Therapeutic Education Program in Patients at High Cardiovascular Risk
A study testing Therapeutic education HTA Vasc in people with High Blood Pressure, run by University Hospital, Lille at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- Therapeutic education HTA Vasc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2011to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Unable to obtain written informed consent
- Patient who are pregnant or lactating
- Person without liberty by administrative or judiciary decision
Trial locations and contacts
2 sites in 1 country.
About this study
Official 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
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.
Read the 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
- Being tested
- Therapeutic education HTA Vasc
- Keywords
- Cardiovascular risk, Therapeutic education, General practice
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic education HTA VascOther
Also called Program proposed by the association 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.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic education HTA Vasc | Experimental | 125 subjects who participate in the therapeutic education program Receives: Other: Therapeutic education HTA Vasc |
| Control group | No intervention | 125 subjects who don't participate in the therapeutic education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Blood Pressure in 12 months
Percentage of patients with a blood pressure of 140/90 mmHg or less in 12 months
Measured: 12 months
Secondary outcomes (1)
High Blood pressure at 24 months
Percentage of patients with a blood pressure of 140/90 mmHg or less in 24 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startSep 2011
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Association HTA Vasc, CRESGE (Centre de Recherches Economiques Sociologiques et de Gestion), CERIM (Centre d'Etudes et de Recherche en Informatique Médicale), P. Devos
- Responsible party
- Sponsor
- Investigators
- FAYOLLE PF Patrick, GP, Principal investigator, Arras Principal InvestigatorGOUDJI GG Gustave, GP, Principal investigator, Lille Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622400
- Sponsor's protocol ID
- 2010-34
- Other IDs
- 2011-A00333-38
- Status last verified
- Jun 2018
- First submitted
- 24 Oct 2011
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01622400
- Acronym / sponsor ID
- 2010-34
- Conditions
- High Blood Pressure
- Keywords
- Cardiovascular risk, Therapeutic education, General practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Association HTA Vasc, CRESGE (Centre de Recherches Economiques Sociologiques et de Gestion), CERIM (Centre d'Etudes et de Recherche en Informatique Médicale), P. Devos
- Study start
- Sep 2011
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 19 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic education HTA Vasc | Experimental | Other: Therapeutic education HTA Vasc125 subjects who participate in the therapeutic education program |
| Control group | No intervention | –125 subjects who don't participate in the therapeutic education program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic education HTA VascAlso: Program proposed by the association HTA VascThe 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 | Therapeutic education HTA Vasc |
Primary outcome
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
1 secondary outcome
High Blood pressure at 24 months
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
Related trials for High Blood Pressure
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FAYOLLE PF Patrick, GP principal investigator
Arras Principal Investigator
GOUDJI GG Gustave, GP principal investigator
Lille Principal Investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic education HTA Vasc in people with High Blood Pressure, run by University Hospital, Lille at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High Blood Pressure in 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.