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Cost-utility Analysis, Cost-e...

Cost-utility Analysis, Cost-effectiveness Analysis, Budget Impact Analysis

Last Updated: 2020-02-25

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

Total Enrollment

960 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2022-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Two strategies are studied in this study:

* Screening for asymptomatic AOMI by measuring IPS
* Management of the FRCV by advices and motivational interviewing

The strategies will be associated according to a factorial plan 2 \* 2 in order to obtain 4 groups:

* Strategy 1: Routine testing for asymptomatic AOMI and management of FRCV.
* Strategy 2: Routine practice of asymptomatic AOMI screening and management of FRCVs by councils and a MA.
* Strategy 3: Systematic Screening of asymptomatic AOMI by measurement of SPI and routine management of FRCV.
* Strategy 4: Systematic screening of asymptomatic AOMI by measuring SPI and taking care of FRCVs by councils and a ME.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

The investigators will include the patients before knowing their randomization arm. This procedure is essential to avoid selection bias by having an effect on the level of recruitment and the profile of the people included in the study.

The initial randomization unit is the CRMG. Eight CRMG will be included in the investigator's study. Four CRMGs will be randomly assigned to the group "systematic AOMI screening by IPS measurement", four CRMG to the "no systematic screening" group. Then, each group thus obtained will be randomly divided into two CRMGs with "advice and EM" and two without CRMG.

Study Groups

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Strategy 1: Usual practice

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Strategy 2: Motivationnal interviewing

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

Group Type EXPERIMENTAL