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

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).

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04283565
Acronym
DAMAGE
Enrollment
614
Registered
2020-02-25
Start date
2021-04-23
Completion date
2025-04-18
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

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

OTHERSystematic screening of AOMI by BPI measurement.

The strategies will be associated according to a 2\*2 factorial design in order to obtain 4 arms

OTHERManagement of CVRF by a motivationnal interviewing.

The strategies will be associated according to a 2\*2 factorial design in order to obtain 4 arms

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

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

Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No

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

MeasureTime frameDescription
ICUR between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors.10 yearsIncremental 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

MeasureTime frameDescription
ICER between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors.10 yearsIncremental 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 years5 yearsBudget 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

PRINCIPAL_INVESTIGATORSebastien BRUEL, Dr

CRMG SAINT ETIENNE

PRINCIPAL_INVESTIGATORClarisse Dr DIBAO DINA, Dr

CRMG TOURS

PRINCIPAL_INVESTIGATORThierry FARGE, Pr

CRMG LYON

PRINCIPAL_INVESTIGATORSophie LALANDE, Dr

CRMG BREST

PRINCIPAL_INVESTIGATORMichel CUNIN, Dr

CRMG LILLE

PRINCIPAL_INVESTIGATORPhilippe VORILHON, Dr

CRMG CLERMONT FERRAND

PRINCIPAL_INVESTIGATORDelphine RUBÉ, Dr

CRMG NANTES 44000

PRINCIPAL_INVESTIGATOREmmanuel ALLORY, Dr

CRMG RENNES Coordinateur régional 53 CCAL PRESIDENT KENNEDY 35000 RENNES

PRINCIPAL_INVESTIGATORJulien FAVIER, Dr

MG SAINT ETIENNE (42300 ROANNE)

PRINCIPAL_INVESTIGATORBastien LAVAL, Dr

MG SAINT ETIENNE (42800 GENILAC)

PRINCIPAL_INVESTIGATORJulien PEYRARD, Dr

MG SAINT ETIENNE (43 120 MONISTROL/LOIRE

PRINCIPAL_INVESTIGATORJean Philippe MELIZAN, Dr

MG SAINT ETIENNE (42260 St Martin la sauveté)

PRINCIPAL_INVESTIGATORCatherine PLOTTON,, Dr

MG SAINT ETIENNE (42230 ROCHE LA MOLIERE)

PRINCIPAL_INVESTIGATOROlivier DURIEUX, Dr

MG SAINT ETIENNE (43240 SAINT JUST MALMONT)

PRINCIPAL_INVESTIGATORClaire CHARRAT, Dr

MG SAINT ETIENNE (43120 MONISTROL SUR LOIRE)

PRINCIPAL_INVESTIGATORMorinne DUPIN, Dr

MG SAINT ETIENNE (43210 BAS EN BASSET)

PRINCIPAL_INVESTIGATORAurélien BARADEL, Dr

MG LYON (01430 ST MARTIN DU FRESNE)

PRINCIPAL_INVESTIGATORMyriam OLIVIA, Dr

MG LYON (38 280 VILLETTE D'ANTHON)

PRINCIPAL_INVESTIGATORDamien MONLOUBOU, Dr

MG LYON (69100 VILLEURBANNE)

PRINCIPAL_INVESTIGATORRonan FOURE,, Dr

MG LYON (01160 PONT D'AIN)

PRINCIPAL_INVESTIGATORNadia HASSAOUI,, Dr

MG LYON (01160 PONT D'AIN)

PRINCIPAL_INVESTIGATORMélanie MICHEL, Dr

MG LYON (01160 PONT D'AIN)

PRINCIPAL_INVESTIGATORPierre DE HAAS, Dr

MG LYON (01160 PONT D'AIN)

PRINCIPAL_INVESTIGATORChloé FAYSSE, Dr

MG LYON (26750 CHATILLON ST JEAN)

PRINCIPAL_INVESTIGATORChristophe PIGACHE, Dr

MG LYON (26330 CHATEAUNEUF DE GALAURE)

PRINCIPAL_INVESTIGATORGérard PETIT, Dr

MG LYON (69007 LYON)

PRINCIPAL_INVESTIGATOREmilie BECK ROBERT, Dr

MG BREST (29620 LANMEUR)

PRINCIPAL_INVESTIGATORHélène CRENN CORVEZ, Dr

MG BREST (29620 LANMEUR)

PRINCIPAL_INVESTIGATOREtienne MELOT,, Dr

MG BREST (22420 LE VIEUX MARCHE)

PRINCIPAL_INVESTIGATORAldric LUCAS, Dr

MG BREST (29190 PLEYBEN)

PRINCIPAL_INVESTIGATORAnton ROBIN YANN, Dr

MG BREST (29 000 QUIMPER)

PRINCIPAL_INVESTIGATORPierre- Marie BOSSER, Dr

MG BREST (29790 PONT CROIX)

PRINCIPAL_INVESTIGATORRoberto PITMAN, Dr

MG BREST (29 400 LANDIVISIAU)

PRINCIPAL_INVESTIGATORPatrick BIARD, Dr

MG TOURS (37210 VOUVRAY)

PRINCIPAL_INVESTIGATORJulie GROSSE, Dr

MG TOURS (37400 AMBOISE)

PRINCIPAL_INVESTIGATORAude LINASSIER, Dr

MG TOURS (37000 TOURS)

PRINCIPAL_INVESTIGATORAnne- Catherine SCHLEGEL, Dr

MG TOURS (37210 PARCAY MESLAY)

PRINCIPAL_INVESTIGATORYann TEISSET, Dr

MG TOURS (37360 ROUZIERS DE TOURAINE)

PRINCIPAL_INVESTIGATORSylvie TIERCIN, Dr

MG TOURS (37000 TOURS)

PRINCIPAL_INVESTIGATORJean- Christophe TUROT, Dr

MG TOURS (37300 JOUE LES TOURS)

PRINCIPAL_INVESTIGATORMaxime PAUTRAT, Dr

MG TOURS (37240 LIGUEIL)

PRINCIPAL_INVESTIGATOROlivier CUVILLIER, Dr

MG TOURS (37390 LA MEMBROLLE SUR CHOISILLE)

PRINCIPAL_INVESTIGATORLudivine BARBEAU, Dr

MG TOURS (41 7000 CHEVERNY)

PRINCIPAL_INVESTIGATORAnita TILLY, Dr

MG LILLE (59280 BOIS GRENIER)

PRINCIPAL_INVESTIGATORLudovic WILLEMS, Dr

MG LILLE (59190 HAZEBROUCK)

PRINCIPAL_INVESTIGATORLaurent TURI, Dr

MG LILLE (62130 GAUCHIN VERLOINGT)

PRINCIPAL_INVESTIGATORNassir MESSAADI, Dr

MG LILLE (59000 LILLE)

PRINCIPAL_INVESTIGATORMarc BAYEN, Dr

MG LILLE (59287 GUESNAIN)

PRINCIPAL_INVESTIGATORAxel DESCAMPS, Dr

MG LILLE (59770 MARLY)

PRINCIPAL_INVESTIGATORSabine BAYEN, Dr

MG LILLE (59287 GUESNAIN)

PRINCIPAL_INVESTIGATORJonathan FAVRE, Dr

MG LILLE (59650 VILLENEUVE D'ASCQ)

PRINCIPAL_INVESTIGATORChristian HULIN, Dr

MG LILLE (62000 ARRAS)

PRINCIPAL_INVESTIGATORJan BARAN, Dr

MG LILLE (59150 WATTRELOS)

PRINCIPAL_INVESTIGATORBenoît CAMBON, Dr

MG CLERMONT FERRAND (03 800 GANNAT)

PRINCIPAL_INVESTIGATORMathilde VICARD OLAGNE, Dr

MG CLERMONT FERRAND (63 580 LE VERNET LA NARENNE)

PRINCIPAL_INVESTIGATORFrédéric TESSIERES, Dr

MG CLERMONT FERRAND (43 100 BRIOUDE)

PRINCIPAL_INVESTIGATORThibault MENINI, Dr

MG CLERMONT FERRAND (63 230 PONTGIBAUD)

PRINCIPAL_INVESTIGATORYves NICOLLIN, Dr

MG CLERMONT FERRAND (63 500 ISSOIRE)

PRINCIPAL_INVESTIGATORGilles TANGUY, Dr

MG CLERMONT FERRAND (63 380 PONTAUMUR)

PRINCIPAL_INVESTIGATORPhilippe MESTRE, Dr

MG CLERMONT FERRAND (43410 LEMPDES)

PRINCIPAL_INVESTIGATORPHILIPPE ZEGANADIN, Dr

MG CLERMONT FERRAND (63190 LEZOUX)

PRINCIPAL_INVESTIGATORVéronique BERTRAND JARROUSSE, Dr

MG CLERMONT FERRAND (6393 AUGEROLLES)

PRINCIPAL_INVESTIGATORAudrey MORICE RAMAT, Dr

MG NANTES (44118 LA CHEVROLIERE)

PRINCIPAL_INVESTIGATORSylvain FOURE, Dr

MG NANTES (85000 LA ROCHE SUR YON)

PRINCIPAL_INVESTIGATORChrystelle PEYRON, Dr

MG NANTES (44160 PONTCHATEAU)

PRINCIPAL_INVESTIGATORMariette RABAUD PELLETIER, Dr

MG NANTES (85340 OLONNE SUR MER)

PRINCIPAL_INVESTIGATORElodie COSSET, Dr

MG NANTES (85430 LES CLOUZEAUX)

PRINCIPAL_INVESTIGATORBrigitte TREGOUET, Dr

MG NANTES (85000 LA ROCHE SUR YON)

PRINCIPAL_INVESTIGATORCécile RABILLER, Dr

MG NANTES (85430 LES CLOUZEAUX)

PRINCIPAL_INVESTIGATORCédric RAT, Dr

MG NANTES (44000 NANTES)

PRINCIPAL_INVESTIGATORAntoine DE GUIBERT, Dr

MG RENNES (35000 RENNES)

PRINCIPAL_INVESTIGATORMathilde GUERIN, Dr

MG RENNES (22690 PLEUDIHEN SUR RANCE)

PRINCIPAL_INVESTIGATORIsabelle EZANNO, Dr

MG RENNES (56950 CRACH)

PRINCIPAL_INVESTIGATORGilles TAPIN, Dr

MG RENNES (35590 L'HERMITAGE)

PRINCIPAL_INVESTIGATORjean- François RICONO, Dr

MG RENNES (35560 ANTRAIN)

PRINCIPAL_INVESTIGATORLaure FIQUET, Dr

MG RENNES (35160 BRETEIL)

PRINCIPAL_INVESTIGATORHervé LE NEEL, Dr

MG RENNES (35200 RENNES)

PRINCIPAL_INVESTIGATORStephane DUQUENNE, Dr

MG RENNES (56240 PLOUAY)

PRINCIPAL_INVESTIGATORArnaud MAURY, Dr

MG RENNES (35470 BAIN DE BRETAGNE)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026