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

Peripheral Arterial Disease Clinical Trial

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Official title:

Health-economic Evaluation of the Care Pathway in General Medicine for High Cardiovascular Risk Patients Based on the Detection of Asymptomatic Lower Limb Peripherial Arterial Disease (AOMI) by the Blood Pressure Index (BPI).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04283565
• Other study ID #: PRM16-ER-DAMAGE
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: February 2020
• Source: University Hospital, Tours
• Contact: Emmanuel RUSCH, Pr
• Phone: 0247476952
• Email: emmanuel.rush[@]univ-tours.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 960
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Other:
• Systematic screening of AOMI by BPI measurement.
The strategies will be associated according to a 2*2 factorial design in order to obtain 4 arms
• Management of CVRF by a motivationnal interviewing.
The strategies will be associated according to a 2*2 factorial design in order to obtain 4 arms

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor

Collaborator

University Hospital, Tours

Collèges Régionaux de Médecine Générale- CRMG - 18600 SANCOINS, Collèges Régionaux de Médecine Générale- CRMG - 26330 Châteauneuf-de-Galaure, Collèges Régionaux de Médecine Générale- CRMG - 29238 BREST, Collèges Régionaux de Médecine Générale- CRMG - 35000 Rennes, Collèges Régionaux de Médecine Générale- CRMG - 37400 Amboise, Collèges Régionaux de Médecine Générale- CRMG - 42270 ST PRIEST EN JAREZ, Collèges Régionaux de Médecine Générale- CRMG - 59110 LA MADELEINE, Collèges Régionaux de Médecine Générale- CRMG - 63 001 CLERMONT FERRAND

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICUR between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors.	Incremental Cost-Utility Ratio (ICUR): Cost per QALY gained at 10 years from the collective and health insurance viewpoint. The quality of life data needed to calculate QALYs will be obtained from the EQ-5D questionnaire and extrapolated to 10 years based on the risk of CV event (SCORE) and prescribed treatments. The costs will be collected by a CRF.	10 years
Secondary	ICER between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors.	Incremental Cost-Effectiveness Ratio (ICER): Cost per prevented cardio-vascular event at 10 years from the collective and health insurance viewpoint. CV events at 10 years will be compute from the SCORE calculation at 2 years. The cost will be collected by a CRF.	10 years
Secondary	ICER between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors.	ICER: Cost per SCORE point less at 2 years from the collective and health insurance viewpoint. The cost will be collected by a CRF.	2 years
Secondary	Budget impact (in €) at 5 years	Budget impact at 5 years from the collective and health insurance viewpoint of the dissemination of the most efficient strategy. The cost will be collected by a CRF.	5 years