Peripheral Arterial Disease
Conditions
Keywords
detection, cost-utility analysis, cost-effectiveness analysis, blood pressure index measurement, motivational interviewing
Brief 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.
Interventions
The strategies will be associated according to a 2\*2 factorial design in order to obtain 4 arms
The strategies will be associated according to a 2\*2 factorial design in order to obtain 4 arms
Sponsors
Study design
Masking description
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.
Intervention model description
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.
Eligibility
Inclusion criteria
CRITERIA FOR INCLUDING PERSONS LENDING TO RESEARCH • Man over 50 years old and under 80 years old or woman over 60 years old and under 90 years old with at least 2 FRCV including at least 1 major FRCV: Major LIFs: * Active or withdrawn smoking for less than 1 year * Type 2 diabetes, treated or not Other FRCV: * Family history: MI, coronary revascularization or sudden death before age 50 with a 1st degree parent * Dyslipidemia: LDL-cholesterol\> 1.3 g / l and / or HDL-cholesterol \<0.4 g / l * hypertension (≥ 140/90 mmHg) for at least 6 months, balanced or not * Sedentary lifestyle * Obesity * Ability to benefit from an EM and to complete a quality of life questionnaire (mastery and understanding of the French language) * Patient affiliated or beneficiary of a social security scheme * Patient who has expressed informed consent CRITERIA FOR NON-INCLUSION OF PERSONS LENDING TO RESEARCH * History of cardiovascular event (symptomatic PADI, acute coronary syndrome, stroke, transient ischemic attack, etc.), therefore patient already in tertiary prevention * Patient participating in another interventional study. * Known asymptomatic PADI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICUR between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors. | 10 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICER between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors. | 10 years | 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. |
| Budget impact (in €) at 5 years | 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. |
Countries
France
Contacts
CRMG SAINT ETIENNE
CRMG TOURS
CRMG LYON
CRMG BREST
CRMG LILLE
CRMG CLERMONT FERRAND
CRMG NANTES 44000
CRMG RENNES Coordinateur régional 53 CCAL PRESIDENT KENNEDY 35000 RENNES
MG SAINT ETIENNE (42300 ROANNE)
MG SAINT ETIENNE (42800 GENILAC)
MG SAINT ETIENNE (43 120 MONISTROL/LOIRE
MG SAINT ETIENNE (42260 St Martin la sauveté)
MG SAINT ETIENNE (42230 ROCHE LA MOLIERE)
MG SAINT ETIENNE (43240 SAINT JUST MALMONT)
MG SAINT ETIENNE (43120 MONISTROL SUR LOIRE)
MG SAINT ETIENNE (43210 BAS EN BASSET)
MG LYON (01430 ST MARTIN DU FRESNE)
MG LYON (38 280 VILLETTE D'ANTHON)
MG LYON (69100 VILLEURBANNE)
MG LYON (01160 PONT D'AIN)
MG LYON (01160 PONT D'AIN)
MG LYON (01160 PONT D'AIN)
MG LYON (01160 PONT D'AIN)
MG LYON (26750 CHATILLON ST JEAN)
MG LYON (26330 CHATEAUNEUF DE GALAURE)
MG LYON (69007 LYON)
MG BREST (29620 LANMEUR)
MG BREST (29620 LANMEUR)
MG BREST (22420 LE VIEUX MARCHE)
MG BREST (29190 PLEYBEN)
MG BREST (29 000 QUIMPER)
MG BREST (29790 PONT CROIX)
MG BREST (29 400 LANDIVISIAU)
MG TOURS (37210 VOUVRAY)
MG TOURS (37400 AMBOISE)
MG TOURS (37000 TOURS)
MG TOURS (37210 PARCAY MESLAY)
MG TOURS (37360 ROUZIERS DE TOURAINE)
MG TOURS (37000 TOURS)
MG TOURS (37300 JOUE LES TOURS)
MG TOURS (37240 LIGUEIL)
MG TOURS (37390 LA MEMBROLLE SUR CHOISILLE)
MG TOURS (41 7000 CHEVERNY)
MG LILLE (59280 BOIS GRENIER)
MG LILLE (59190 HAZEBROUCK)
MG LILLE (62130 GAUCHIN VERLOINGT)
MG LILLE (59000 LILLE)
MG LILLE (59287 GUESNAIN)
MG LILLE (59770 MARLY)
MG LILLE (59287 GUESNAIN)
MG LILLE (59650 VILLENEUVE D'ASCQ)
MG LILLE (62000 ARRAS)
MG LILLE (59150 WATTRELOS)
MG CLERMONT FERRAND (03 800 GANNAT)
MG CLERMONT FERRAND (63 580 LE VERNET LA NARENNE)
MG CLERMONT FERRAND (43 100 BRIOUDE)
MG CLERMONT FERRAND (63 230 PONTGIBAUD)
MG CLERMONT FERRAND (63 500 ISSOIRE)
MG CLERMONT FERRAND (63 380 PONTAUMUR)
MG CLERMONT FERRAND (43410 LEMPDES)
MG CLERMONT FERRAND (63190 LEZOUX)
MG CLERMONT FERRAND (6393 AUGEROLLES)
MG NANTES (44118 LA CHEVROLIERE)
MG NANTES (85000 LA ROCHE SUR YON)
MG NANTES (44160 PONTCHATEAU)
MG NANTES (85340 OLONNE SUR MER)
MG NANTES (85430 LES CLOUZEAUX)
MG NANTES (85000 LA ROCHE SUR YON)
MG NANTES (85430 LES CLOUZEAUX)
MG NANTES (44000 NANTES)
MG RENNES (35000 RENNES)
MG RENNES (22690 PLEUDIHEN SUR RANCE)
MG RENNES (56950 CRACH)
MG RENNES (35590 L'HERMITAGE)
MG RENNES (35560 ANTRAIN)
MG RENNES (35160 BRETEIL)
MG RENNES (35200 RENNES)
MG RENNES (56240 PLOUAY)
MG RENNES (35470 BAIN DE BRETAGNE)