Study to Improve Quality of Care and Patient Health in the Field of Cardiovascular Risk Factors in General Practice
NCT ID: NCT00348855
Last Updated: 2011-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1836 participants
INTERVENTIONAL
2006-11-30
2010-03-31
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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1
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.
Cardiovascular drugs strategies
Implementation of drug strategies according to guidelines to try to reach goals proposed in these guidelines.
Compliance
Discussion about compliance and questionnaire to assess compliance at inclusion, Year 1 and Year 2.
Exercise
Discussion with the patient on necessity to have regular exercise. Assessment of exercise by questionnaire at inclusion, year 1 and year 2.
Stop Smoking
Minimal intervention
Diet
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 Back
Feed back on results in the intervention group at baseline, Year 1 ans Year 2.
2
No interventions assigned to this group
Interventions
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Cardiovascular drugs strategies
Implementation of drug strategies according to guidelines to try to reach goals proposed in these guidelines.
Compliance
Discussion about compliance and questionnaire to assess compliance at inclusion, Year 1 and Year 2.
Exercise
Discussion with the patient on necessity to have regular exercise. Assessment of exercise by questionnaire at inclusion, year 1 and year 2.
Stop Smoking
Minimal intervention
Diet
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 Back
Feed back on results in the intervention group at baseline, Year 1 ans Year 2.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
40 Years
75 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Assistance Publique - Hôpitaux de Paris
OTHER
Laboratoires Takeda
INDUSTRY
Merck Serono International SA
INDUSTRY
Collège National des Généralistes Enseignants
OTHER
Responsible Party
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Denis Pouchain
MD
Principal Investigators
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Denis POUCHAIN, MD
Role: PRINCIPAL_INVESTIGATOR
French National College of GP Teatchers
Michel LIEVRE, MD
Role: STUDY_DIRECTOR
EZUS LYON
Dominique HUAS, MD
Role: STUDY_DIRECTOR
French National College of GP Teatchers
Locations
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Service de Pharmacologie Clinique
Lyon, , France
French National College of GP Teatchers
Vincennes, , France
Countries
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References
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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.
Pouchain 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 Links
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Related Info
Other Identifiers
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CNGE20060702
Identifier Type: -
Identifier Source: org_study_id