Cost-utility Analysis, Cost-effectiveness Analysis, Budget Impact Analysis (DAMAGE)

Regional University Hospital Center (CHRU)

Status: Unknown

Conditions: Peripheral Arterial Disease

Treatments: Other: Management of CVRF by a motivationnal interviewing.; Other: Systematic screening of AOMI by BPI measurement.

Study type: Interventional

Funder types: Other

Identifiers

NCT04283565

PRM16-ER-DAMAGE

Details and patient eligibility

About

Cardiovascular pathologies (CV), the second leading cause of death just behind tumors, are particularly frequent in France and strongly mobilize the resources of the healthcare system (ambulatory and health facility). The French High Authority for Health (HAS) has defined major cardio-vascular risk factors (CVRF): smoking, high blood pressure (hypertension), elevated total cholesterol (TC) or LDL, decreased HDL cholesterol, type II diabetes and age, and predisposing CVRF or discussed: obesity, sedentary lifestyle, menopause, elevation of triglycerides and genetic factors.

Lower-linb peripherial arterial disease (AOMI), even if asymptomatic, involves systemic atherial disease, responsible for mortality irrespective of the presence of CVRF. The prevalence of asymptomatic AOMI is 10 to 20% beyond 55 years old, and the associated mortality is 18 to 30% at 5 years.

Individual screening is achievable by well-conducted clinical evaluation and systematic measurement of the simple, non-invasive Blood Pressure Index (BPI) in all subjects at risk. A BPI<0.9 indicates an event risk close to that of the symptomatic patient. However, if this strategy is recommended by the HAS, it is not carried out systematically in current practice. Therapeutic means available for the management of an asymptomatic AOMI are the identification and support for controllable CVRF such as smoking and nutrition (diet and physical activity) in the context of secondary prevention of atherosclerosis. Thus, the generalization of a systematique screening strategy of AOMI, allowing faster handling of CVRF by advices and Motivational Interviewing (MI), could have a significant impact, both clinically and economically.

Patients could also benefit from this support in terms of quality of life both on the physiological dimension (effect of weight loss, correction of disorders of cardiac function, etc.), that on the psychic dimension (well-being of patients, management of disorders anxious). However, few studies have evaluated the benefit of such a strategy in terms of quality-adjusted life years (QALYs),none did it on a cost recovery basis. No such studies have been conducted in France.

The feasibility of this project is based on the success of a pilot study conducted in Centre-Val de Loire region (France) in 2013. It showed that the implementation of a strategy of systematic screening of the asymptomatic AOMI based on the measurement of the BPI in high cardiovascular risk patients is feasible in current practice by general practitioners, and could be more efficient than interventions performed in current practice.

Enrollment: 960 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Man over 50 and under 80 or woman over 60 and under 90 with at least 2 CVRF including at least 1 major CVRF (Major CVRF: Active or stopped smoking for less than 3 years; Type II treated or not treated Diabetes; Other CVRF: Family history: myocardial infarction, sudden death <55 years (male first degree relative) or <65 years (female first degree relative) or Cerebrovascular Stroke (CVA) < 45 years old; Dyslipidemia: LDL-cholesterol> 1.6 g/L and / or HDL-cholesterol <0.4 g/L; HTA (≥ 140/90 mmHg) for at least 6 months, balanced or not)
• Ability to benefit of an Motivational interviewing and to complete a quality of life questionnaire (fluent in french)
• Social insured patient
• Informed consent

Exclusion criteria

• History of cardiovascular event (symptomatic AOMI, acute coronary syndrome, stroke, transient ischemic attack ...), therefore patient already in tertiary prevention
• Patient included in another interventional study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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960 participants in 4 patient groups

Strategy 1: Usual practice

No Intervention group

Description:

No systematic screening of asymptomatic AOMI and routine management of FRCV.

Strategy 2: Motivationnal interviewing

Experimental group

Description:

No systematic screening of asymptomatic AOMI and management of CVRF by a motivationnal interviewing.

Treatment:

Other: Management of CVRF by a motivationnal interviewing.

Strategy 3: Systematic screening of AOMI by BPI measurement

Experimental group

Description:

Systematic screening of AOMI by BPI measurement and routine management of FRCV.

Treatment:

Other: Systematic screening of AOMI by BPI measurement.

Strategy 4: Both strategies

Experimental group

Description:

Systematic screening of AOMI by BPI measurement and management of CVRF by a motivationnal interviewing.

Treatment:

Other: Management of CVRF by a motivationnal interviewing.

Other: Systematic screening of AOMI by BPI measurement.