High Risk Hypertensive PatientsPhase 4ESCAPENCT00348855
Study to Improve Quality of Care and Patient Health in the Field of Cardiovascular Risk Factors in General Practice
A Phase 4 study testing Cardiovascular drugs strategies, Compliance and Exercise in people with High Risk Hypertensive Patients, run by Collège National des Généralistes Enseignants at 2 sites in France.
Trial summary
Observational studies performed in France and abroad in hypertensive patients at high cardiovascular risk have shown a wide gap between the therapeutic targets reached in ambulatory patients and those set by guidelines. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- High Risk Hypertensive Patients
- What is being tested?
- Cardiovascular drugs strategies, Compliance and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,836 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2006to Mar 2010
- Phase
- Phase 4
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treated High blood Pressure patients with at least two other cardiovascular risks
Who cannot join
- Secondary prevention
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de Pharmacologie Clinique
Lyon, 69376
French National College of GP Teatchers
Vincennes, 94300
About this study
Official title: Effects of a Series of Intensified Prevention Consultations on the Changes in Goals and Risk Factors in Hypertensive Patients at High Cardiovascular Risk
Observational studies performed in France and abroad in hypertensive patients at high cardiovascular risk have shown a wide gap between the therapeutic targets reached in ambulatory patients and those set by guidelines. In primary prevention, in hypertensive patients at high cardiovascular risk (+ at least 2 risk factors), the gap is secondary to 1) the ignorance of the validated therapeutic targets and strategies, 2) the absence of global cardiovascular risk management, 3) the usual ambulatory medical practice, which is not adapted to a global cardiovascular prevention approach.
Objectives Principal. To demonstrate that a series of 5 specific prevention consultations over 2 years allows a greater number of hypertensive patients at high cardiovascular risk to reach the goals set by guidelines with no deterioration of their quality of life compared with no particular intervention.
Read more
Method Pragmatic, cluster-randomised controlled trial. At least 1904 high cardiovascular risk hypertensive patients will be included and followed up during two years by 268 teaching general practitioners from 23 regional teaching colleges. The regional teaching colleges will be randomised to avoid a contamination bias. The study will be coordinated by local coordinators at the college level.
Intervention In the intervention group, the investigators will have training, information, and feed back regarding the management of high risk hypertensive patients. The training will concern the targets to be reached, therapeutic strategies recommended by the AFSSAPS/HAS, and scientific data. The investigators will have an easy guide that can be used during consultations, and will be informed about tobacco withdrawal programs and education for improving diet, exercise and compliance.
In the control group, investigators will care for their patients as usual. End points Main: number of patients who reach all the therapeutic targets defined by the guidelines in the total study population, in the sub-group of patients with hypertension, but free of type-2 diabetes (T2D), and in the sub-group with hypertension and DT2.
Secondary: number of targets reached by the patients, changes in level of blood pressure, LDL-cholesterol, HbA1c, tobacco consumption, and use of aspirin if needed in the total population and its two subgroups, estimated cardiovascular risk, quality of life.
Read the detailed description
Cluster randomised pragmatic controlled trial in general practice
- Conditions
- High Risk Hypertensive Patients
- Being tested
- Cardiovascular drugs strategies, Compliance, Exercise, Stop Smoking, Diet
- Keywords
- High Blood Pressure, High cardiovascular risk, Type 2 diabetes, Reaching goals
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular drugs strategiesOther
Implementation of drug strategies according to guidelines to try to reach goals proposed in these guidelines.
ComplianceBehavioural
Discussion about compliance and questionnaire to assess compliance at inclusion, Year 1 and Year 2.
ExerciseBehavioural
Discussion with the patient on necessity to have regular exercise. Assessment of exercise by questionnaire at inclusion, year 1 and year 2.
Stop SmokingBehavioural
Minimal intervention
DietBehavioural
Discussion with the patient on his (her) alimentation during each of the six consultations and assessment of daily diet at inclusion, year 1 and year 2.
Feed BackOther
Feed back on results in the intervention group at baseline, Year 1 ans Year 2.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intervention with one day training, electronic device to measure bood pressure, leaflet with goals and drug strategies according to guidelines, six specific cardiovascular consultations during two years, feed back on results of the intervention group at inclusion, year 1 and year 2.
Specific consultations will be focused on goals to be reach, compliance, exercise and diet. Receives: Other: Cardiovascular drugs strategies; Behavioral: Compliance; Behavioral: Exercise; Behavioral: Stop Smoking; Behavioral: Diet; Other: Feed Back |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who reach all the therapeutic goals defined by the guidelines in the total study population, in the sub-group of patients with hypertension, but free of type-2 diabetes (T2D), and in the sub-group with hypertension and T2D.
Measured: At inclusion, year 1 and year 2
Secondary outcomes (6)
Number of targets reached by the patients
Measured: At inclusion, year 1 and year 2
Quality of life measured with SF8
Measured: At inclusion, year 1 and year 2
Compliance
Measured: At inclusion, year 1 and year 2
Exercise
Measured: At inclusion, year 1 and year 2
Diet
Measured: At inclusion, year 1 and year 2
Levels of blood pressure, LDL-Cholesterol, tobacco consumption in the whole population plus levels of HbA1c and aspirin use in the TD2 population
Measured: inclusion, year 1 and year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study startNov 2006
- Primary completionSep 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for High Risk Hypertensive PatientsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,836 participants (actual)
Sponsor and investigators
- Lead sponsor
- Collège National des Généralistes Enseignants
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Assistance Publique - Hôpitaux de Paris, Laboratoires Takeda, Merck Serono International SA
- Responsible party
- Principal investigator, Denis Pouchain, Collège National des Généralistes Enseignants
- Investigators
- Denis POUCHAIN, MD, Principal investigator, French National College of GP TeatchersMichel LIEVRE, MD, Study director, EZUS LYONDominique HUAS, MD, Study director, French National College of GP Teatchers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348855
- Sponsor's protocol ID
- CNGE20060702
- Acronym
- ESCAPE
- Status last verified
- Nov 2011
- First submitted
- 3 Jul 2006
- Last updated
- 15 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lebeau JP, Cadwallader JS, Vaillant-Roussel H, Pouchain D, Yaouanc V, Aubin-Auger I, Mercier A, Rusch E, Remmen R, Vermeire E, Hendrickx K. General practitioners' justifications for therapeutic inertia in cardiovascular prevention: an empirically grounded typology. BMJ Open. 2016 May 13;6(5):e010639. doi: 10.1136/bmjopen-2015-010639.
PubMed 27178974Pouchain D, Lievre M, Huas D, Lebeau JP, Renard V, Bruckert E, Girerd X, Boutitie F; French National College of Teachers in General Practice. Effects of a multifaceted intervention on cardiovascular risk factors in high-risk hypertensive patients: the ESCAPE trial, a pragmatic cluster randomized trial in general practice. Trials. 2013 Oct 1;14:318. doi: 10.1186/1745-6215-14-318.
PubMed 24083783
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Series of Intensified Prevention Consultations on the Changes in Goals and Risk Factors in Hypertensive Patients at High Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT00348855
- Acronym / sponsor ID
- ESCAPE / CNGE20060702
- Conditions
- High Risk Hypertensive Patients
- Keywords
- High Blood Pressure, High cardiovascular risk, Type 2 diabetes, Reaching goals
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,836 participants (actual)
- Lead sponsor
- Collège National des Généralistes EnseignantsUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Assistance Publique - Hôpitaux de Paris, Laboratoires Takeda, Merck Serono International SA
- Study start
- Nov 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 6 Jul 2006 (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.
Observational studies performed in France and abroad in hypertensive patients at high cardiovascular risk have shown a wide gap between the therapeutic targets reached in ambulatory patients and those set by guidelines. In primary prevention, in hypertensive patients at high cardiovascular risk (+ at least 2 risk factors), the gap is secondary to 1) the ignorance of the validated therapeutic targets and strategies, 2) the absence of global cardiovascular risk management, 3) the usual ambulatory medical practice, which is not adapted to a global cardiovascular prevention approach.
Objectives Principal. To demonstrate that a series of 5 specific prevention consultations over 2 years allows a greater number of hypertensive patients at high cardiovascular risk to reach the goals set by guidelines with no deterioration of their quality of life compared with no particular intervention.
Method Pragmatic, cluster-randomised controlled trial. At least 1904 high cardiovascular risk hypertensive patients will be included and followed up during two years by 268 teaching general practitioners from 23 regional teaching colleges. The regional teaching colleges will be randomised to avoid a contamination bias. The study will be coordinated by local coordinators at the college level.
Intervention In the intervention group, the investigators will have training, information, and feed back regarding the management of high risk hypertensive patients. The training will concern the targets to be reached, therapeutic strategies recommended by the AFSSAPS/HAS, and scientific data. The investigators will have an easy guide that can be used during consultations, and will be informed about tobacco withdrawal programs and education for improving diet, exercise and compliance.
In the control group, investigators will care for their patients as usual. End points Main: number of patients who reach all the therapeutic targets defined by the guidelines in the total study population, in the sub-group of patients with hypertension, but free of type-2 diabetes (T2D), and in the sub-group with hypertension and DT2.
Secondary: number of targets reached by the patients, changes in level of blood pressure, LDL-cholesterol, HbA1c, tobacco consumption, and use of aspirin if needed in the total population and its two subgroups, estimated cardiovascular risk, quality of life.
Detailed description
Cluster randomised pragmatic controlled trial in general practice
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Cardiovascular drugs strategies, Behavioral: Compliance, Behavioral: Exercise, Behavioral: Stop Smoking, Behavioral: Diet, Other: Feed BackIntervention with one day training, electronic device to measure bood pressure, leaflet with goals and drug strategies according to guidelines, six specific cardiovascular consultations during two years, feed back on results of the intervention group at inclusion, year 1 and year 2. Specific consultations will be focused on goals to be reach, compliance, exercise and diet. |
| 2 | No intervention | – |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Treated High blood Pressure patients with at least two other cardiovascular risks
Key exclusion criteria (1 listed)
- Secondary prevention
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 |
|---|---|---|
| Cardiovascular drugs strategiesImplementation of drug strategies according to guidelines to try to reach goals proposed in these guidelines. | Other | 1 |
| ComplianceDiscussion about compliance and questionnaire to assess compliance at inclusion, Year 1 and Year 2. | Behavioural | 1 |
| ExerciseDiscussion with the patient on necessity to have regular exercise. Assessment of exercise by questionnaire at inclusion, year 1 and year 2. | Behavioural | 1 |
| Stop SmokingMinimal intervention | Behavioural | 1 |
| DietDiscussion with the patient on his (her) alimentation during each of the six consultations and assessment of daily diet at inclusion, year 1 and year 2. | Behavioural | 1 |
| Feed BackFeed back on results in the intervention group at baseline, Year 1 ans Year 2. | Other | 1 |
Primary outcome
Number of patients who reach all the therapeutic goals defined by the guidelines in the total study population, in the sub-group of patients with hypertension, but free of type-2 diabetes (T2D), and in the sub-group with hypertension and T2D.
Time frame: At inclusion, year 1 and year 2
6 secondary outcomes
Number of targets reached by the patients
Time frame: At inclusion, year 1 and year 2
Quality of life measured with SF8
Time frame: At inclusion, year 1 and year 2
Compliance
Time frame: At inclusion, year 1 and year 2
Exercise
Time frame: At inclusion, year 1 and year 2
Diet
Time frame: At inclusion, year 1 and year 2
Levels of blood pressure, LDL-Cholesterol, tobacco consumption in the whole population plus levels of HbA1c and aspirin use in the TD2 population
Time frame: inclusion, year 1 and year 2
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 15 Nov 2011.
- Derived from this study: PubMed 27178974Lebeau JP, Cadwallader JS, Vaillant-Roussel H, Pouchain D, Yaouanc V, Aubin-Auger I, Mercier A, Rusch E, Remmen R, Vermeire E, Hendrickx K. General practitioners' justifications for therapeutic inertia in cardiovascular prevention: an empirically grounded typology. BMJ Open. 2016 May 13;6(5):e010639. doi: 10.1136/bmjopen-2015-010639.
- Derived from this study: PubMed 24083783Pouchain D, Lievre M, Huas D, Lebeau JP, Renard V, Bruckert E, Girerd X, Boutitie F; French National College of Teachers in General Practice. Effects of a multifaceted intervention on cardiovascular risk factors in high-risk hypertensive patients: the ESCAPE trial, a pragmatic cluster randomized trial in general practice. Trials. 2013 Oct 1;14:318. doi: 10.1186/1745-6215-14-318.
- Related InfoLink provided by the sponsor.
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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.
Denis POUCHAIN, MD principal investigator
French National College of GP Teatchers
Michel LIEVRE, MD study director
EZUS LYON
Dominique HUAS, MD study director
French National College of GP Teatchers
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cardiovascular drugs strategies, Compliance and Exercise in people with High Risk Hypertensive Patients, run by Collège National des Généralistes Enseignants 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 1 inclusion and 1 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 15 Nov 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of patients who reach all the therapeutic goals defined by the guidelines in the total study population, in the sub-group of patients with hypertension, but free of type-2 diabetes (T2D), and in the sub-group with hypertension and T2D. (time frame: At inclusion, year 1 and year 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00348855, which also lists 2 linked publications.
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 15 Nov 2011.