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Study to Improve Quality of Care and Patient Health in the Field of Cardiovascular Risk Factors in General Practice (ESCAPE)

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ClinicalTrials.gov Identifier: NCT00348855
Recruitment Status : Completed
First Posted : July 6, 2006
Last Update Posted : November 15, 2011
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Assistance Publique - Hôpitaux de Paris
Laboratoires Takeda
Merck Serono International SA
Information provided by (Responsible Party):
Denis Pouchain, Collège National des Généralistes Enseignants

Brief 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. 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.


Condition or disease Intervention/treatment Phase
High Risk Hypertensive Patients Other: Cardiovascular drugs strategies Behavioral: Compliance Behavioral: Exercise Behavioral: Stop Smoking Behavioral: Diet Other: Feed Back Phase 4

Detailed Description:
Cluster randomised pragmatic controlled trial in general practice

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1836 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
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
Study Start Date : November 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : March 2010

Arm Intervention/treatment
Experimental: 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.

Other: Cardiovascular drugs strategies
Implementation of drug strategies according to guidelines to try to reach goals proposed in these guidelines.

Behavioral: Compliance
Discussion about compliance and questionnaire to assess compliance at inclusion, Year 1 and Year 2.

Behavioral: Exercise
Discussion with the patient on necessity to have regular exercise. Assessment of exercise by questionnaire at inclusion, year 1 and year 2.

Behavioral: Stop Smoking
Minimal intervention

Behavioral: 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.

Other: Feed Back
Feed back on results in the intervention group at baseline, Year 1 ans Year 2.

No Intervention: 2



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Number of targets reached by the patients [ Time Frame: At inclusion, year 1 and year 2 ]
  2. Quality of life measured with SF8 [ Time Frame: At inclusion, year 1 and year 2 ]
  3. Compliance [ Time Frame: At inclusion, year 1 and year 2 ]
  4. Exercise [ Time Frame: At inclusion, year 1 and year 2 ]
  5. Diet [ Time Frame: At inclusion, year 1 and year 2 ]
  6. 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 ]


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treated High blood Pressure patients with at least two other cardiovascular risks

Exclusion Criteria:

  • Secondary prevention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348855


Locations
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France
Service de Pharmacologie Clinique
Lyon, France, 69376
French National College of GP Teatchers
Vincennes, France, 94300
Sponsors and Collaborators
Collège National des Généralistes Enseignants
Institut National de la Santé Et de la Recherche Médicale, France
Assistance Publique - Hôpitaux de Paris
Laboratoires Takeda
Merck Serono International SA
Investigators
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Principal Investigator: Denis POUCHAIN, MD French National College of GP Teatchers
Study Director: Michel LIEVRE, MD EZUS LYON
Study Director: Dominique HUAS, MD French National College of GP Teatchers

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Denis Pouchain, MD, Collège National des Généralistes Enseignants
ClinicalTrials.gov Identifier: NCT00348855     History of Changes
Other Study ID Numbers: CNGE20060702
First Posted: July 6, 2006    Key Record Dates
Last Update Posted: November 15, 2011
Last Verified: November 2011

Keywords provided by Denis Pouchain, Collège National des Généralistes Enseignants:
High Blood Pressure
High cardiovascular risk
Type 2 diabetes
Reaching goals