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

NCT00348855 | Completed Phase 4 DMC

• 1 other identifier: CNGE20060702
• Study Type: interventional
• Target: 1,836
• Locations: 1 country
• Sites: 2

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.

Conditions

High Risk Hypertensive Patients

Keywords

High Blood Pressure; High cardiovascular risk; Type 2 diabetes; Reaching goals

Outcome Measures

Primary Outcomes (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.

  At inclusion, year 1 and year 2

Secondary Outcomes (6)

• Number of targets reached by the patients

  At inclusion, year 1 and year 2

• Quality of life measured with SF8

  At inclusion, year 1 and year 2

• Compliance

  At inclusion, year 1 and year 2

• Exercise

  At inclusion, year 1 and year 2

• Diet

  At inclusion, year 1 and year 2

Study Arms (2)

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.

Other: Cardiovascular drugs strategies; Behavioral: Compliance; Behavioral: Exercise; Behavioral: Stop Smoking; Behavioral: Diet; Other: Feed Back

2

NO INTERVENTION

Interventions

Cardiovascular drugs strategies OTHER

Implementation of drug strategies according to guidelines to try to reach goals proposed in these guidelines.

1

Compliance BEHAVIORAL

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

1

Exercise BEHAVIORAL

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

1

Stop Smoking BEHAVIORAL

Minimal intervention

1

Diet BEHAVIORAL

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.

1

Feed Back OTHER

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

1

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Secondary prevention

Sponsors & Collaborators

• Collège National des Généralistes Enseignants: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Assistance Publique - Hôpitaux de Paris: collaborator
• Laboratoires Takeda: collaborator
• Merck Serono International SA: collaborator

Study Sites (2)

Service de Pharmacologie Clinique

Lyon, 69376, France

Location

French National College of GP Teatchers

Vincennes, 94300, France

Location

Related Publications (2)

• 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.

  PMID: 27178974 DERIVED

• 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.

  PMID: 24083783 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2

Interventions

Compliance; Exercise; Diet

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Elasticity; Mechanical Phenomena; Physical Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Denis POUCHAIN, MD

  French National College of GP Teatchers

  PRINCIPAL INVESTIGATOR

• Michel LIEVRE, MD

  EZUS LYON

  STUDY DIRECTOR

• Dominique HUAS, MD

  French National College of GP Teatchers

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 3, 2006
• First Posted: July 6, 2006
• Study Start: November 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: March 1, 2010
• Last Updated: November 15, 2011

Record last verified: 2011-11

Locations

FR (2)