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

NCT04283565 | Completed DMC

• 1 other identifier: PRM16-ER-DAMAGE
• Study Type: interventional
• Target: 614
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

detection; cost-utility analysis; cost-effectiveness analysis; blood pressure index measurement; motivational interviewing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• ICER between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors.

  10 years

• ICER between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors.

  2 years

• Budget impact (in €) at 5 years

  5 years

Study Arms (4)

Strategy 1: Usual practice

NO INTERVENTION

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

Strategy 2: Motivationnal interviewing

EXPERIMENTAL

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

Other: Management of CVRF by a motivationnal interviewing.

Strategy 3: Systematic screening of AOMI by BPI measurement

EXPERIMENTAL

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

Other: Systematic screening of AOMI by BPI measurement.

Strategy 4: Both strategies

EXPERIMENTAL

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

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

Interventions

Systematic screening of AOMI by BPI measurement. OTHER

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

Strategy 3: Systematic screening of AOMI by BPI measurement; Strategy 4: Both strategies

Management of CVRF by a motivationnal interviewing. OTHER

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

Strategy 2: Motivationnal interviewing; Strategy 4: Both strategies

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (1)

BRUEL

Saint-Etienne, France

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Sebastien BRUEL, Dr

  CRMG SAINT ETIENNE

  PRINCIPAL INVESTIGATOR

• Clarisse Dr DIBAO DINA, Dr

  CRMG TOURS

  PRINCIPAL INVESTIGATOR

• Thierry FARGE, Pr

  CRMG LYON

  PRINCIPAL INVESTIGATOR

• Sophie LALANDE, Dr

  CRMG BREST

  PRINCIPAL INVESTIGATOR

• Michel CUNIN, Dr

  CRMG LILLE

  PRINCIPAL INVESTIGATOR

• Philippe VORILHON, Dr

  CRMG CLERMONT FERRAND

  PRINCIPAL INVESTIGATOR

• Delphine RUBÉ, Dr

  CRMG NANTES 44000

  PRINCIPAL INVESTIGATOR

• Emmanuel ALLORY, Dr

  CRMG RENNES Coordinateur régional 53 CCAL PRESIDENT KENNEDY 35000 RENNES

  PRINCIPAL INVESTIGATOR

• Julien FAVIER, Dr

  MG SAINT ETIENNE (42300 ROANNE)

  PRINCIPAL INVESTIGATOR

• Bastien LAVAL, Dr

  MG SAINT ETIENNE (42800 GENILAC)

  PRINCIPAL INVESTIGATOR

• Julien PEYRARD, Dr

  MG SAINT ETIENNE (43 120 MONISTROL/LOIRE

  PRINCIPAL INVESTIGATOR

• Jean Philippe MELIZAN, Dr

  MG SAINT ETIENNE (42260 St Martin la sauveté)

  PRINCIPAL INVESTIGATOR

• Catherine PLOTTON,, Dr

  MG SAINT ETIENNE (42230 ROCHE LA MOLIERE)

  PRINCIPAL INVESTIGATOR

• Olivier DURIEUX, Dr

  MG SAINT ETIENNE (43240 SAINT JUST MALMONT)

  PRINCIPAL INVESTIGATOR

• Claire CHARRAT, Dr

  MG SAINT ETIENNE (43120 MONISTROL SUR LOIRE)

  PRINCIPAL INVESTIGATOR

• Morinne DUPIN, Dr

  MG SAINT ETIENNE (43210 BAS EN BASSET)

  PRINCIPAL INVESTIGATOR

• Aurélien BARADEL, Dr

  MG LYON (01430 ST MARTIN DU FRESNE)

  PRINCIPAL INVESTIGATOR

• Myriam OLIVIA, Dr

  MG LYON (38 280 VILLETTE D'ANTHON)

  PRINCIPAL INVESTIGATOR

• Damien MONLOUBOU, Dr

  MG LYON (69100 VILLEURBANNE)

  PRINCIPAL INVESTIGATOR

• Ronan FOURE,, Dr

  MG LYON (01160 PONT D'AIN)

  PRINCIPAL INVESTIGATOR

• Nadia HASSAOUI,, Dr

  MG LYON (01160 PONT D'AIN)

  PRINCIPAL INVESTIGATOR

• Mélanie MICHEL, Dr

  MG LYON (01160 PONT D'AIN)

  PRINCIPAL INVESTIGATOR

• Pierre DE HAAS, Dr

  MG LYON (01160 PONT D'AIN)

  PRINCIPAL INVESTIGATOR

• Chloé FAYSSE, Dr

  MG LYON (26750 CHATILLON ST JEAN)

  PRINCIPAL INVESTIGATOR

• Christophe PIGACHE, Dr

  MG LYON (26330 CHATEAUNEUF DE GALAURE)

  PRINCIPAL INVESTIGATOR

• Gérard PETIT, Dr

  MG LYON (69007 LYON)

  PRINCIPAL INVESTIGATOR

• Emilie BECK ROBERT, Dr

  MG BREST (29620 LANMEUR)

  PRINCIPAL INVESTIGATOR

• Hélène CRENN CORVEZ, Dr

  MG BREST (29620 LANMEUR)

  PRINCIPAL INVESTIGATOR

• Etienne MELOT,, Dr

  MG BREST (22420 LE VIEUX MARCHE)

  PRINCIPAL INVESTIGATOR

• Aldric LUCAS, Dr

  MG BREST (29190 PLEYBEN)

  PRINCIPAL INVESTIGATOR

• Anton ROBIN YANN, Dr

  MG BREST (29 000 QUIMPER)

  PRINCIPAL INVESTIGATOR

• Pierre- Marie BOSSER, Dr

  MG BREST (29790 PONT CROIX)

  PRINCIPAL INVESTIGATOR

• Roberto PITMAN, Dr

  MG BREST (29 400 LANDIVISIAU)

  PRINCIPAL INVESTIGATOR

• Patrick BIARD, Dr

  MG TOURS (37210 VOUVRAY)

  PRINCIPAL INVESTIGATOR

• Julie GROSSE, Dr

  MG TOURS (37400 AMBOISE)

  PRINCIPAL INVESTIGATOR

• Aude LINASSIER, Dr

  MG TOURS (37000 TOURS)

  PRINCIPAL INVESTIGATOR

• Anne- Catherine SCHLEGEL, Dr

  MG TOURS (37210 PARCAY MESLAY)

  PRINCIPAL INVESTIGATOR

• Yann TEISSET, Dr

  MG TOURS (37360 ROUZIERS DE TOURAINE)

  PRINCIPAL INVESTIGATOR

• Sylvie TIERCIN, Dr

  MG TOURS (37000 TOURS)

  PRINCIPAL INVESTIGATOR

• Jean- Christophe TUROT, Dr

  MG TOURS (37300 JOUE LES TOURS)

  PRINCIPAL INVESTIGATOR

• Maxime PAUTRAT, Dr

  MG TOURS (37240 LIGUEIL)

  PRINCIPAL INVESTIGATOR

• Olivier CUVILLIER, Dr

  MG TOURS (37390 LA MEMBROLLE SUR CHOISILLE)

  PRINCIPAL INVESTIGATOR

• Ludivine BARBEAU, Dr

  MG TOURS (41 7000 CHEVERNY)

  PRINCIPAL INVESTIGATOR

• Anita TILLY, Dr

  MG LILLE (59280 BOIS GRENIER)

  PRINCIPAL INVESTIGATOR

• Ludovic WILLEMS, Dr

  MG LILLE (59190 HAZEBROUCK)

  PRINCIPAL INVESTIGATOR

• Laurent TURI, Dr

  MG LILLE (62130 GAUCHIN VERLOINGT)

  PRINCIPAL INVESTIGATOR

• Nassir MESSAADI, Dr

  MG LILLE (59000 LILLE)

  PRINCIPAL INVESTIGATOR

• Marc BAYEN, Dr

  MG LILLE (59287 GUESNAIN)

  PRINCIPAL INVESTIGATOR

• Axel DESCAMPS, Dr

  MG LILLE (59770 MARLY)

  PRINCIPAL INVESTIGATOR

• Sabine BAYEN, Dr

  MG LILLE (59287 GUESNAIN)

  PRINCIPAL INVESTIGATOR

• Jonathan FAVRE, Dr

  MG LILLE (59650 VILLENEUVE D'ASCQ)

  PRINCIPAL INVESTIGATOR

• Christian HULIN, Dr

  MG LILLE (62000 ARRAS)

  PRINCIPAL INVESTIGATOR

• Jan BARAN, Dr

  MG LILLE (59150 WATTRELOS)

  PRINCIPAL INVESTIGATOR

• Benoît CAMBON, Dr

  MG CLERMONT FERRAND (03 800 GANNAT)

  PRINCIPAL INVESTIGATOR

• Mathilde VICARD OLAGNE, Dr

  MG CLERMONT FERRAND (63 580 LE VERNET LA NARENNE)

  PRINCIPAL INVESTIGATOR

• Frédéric TESSIERES, Dr

  MG CLERMONT FERRAND (43 100 BRIOUDE)

  PRINCIPAL INVESTIGATOR

• Thibault MENINI, Dr

  MG CLERMONT FERRAND (63 230 PONTGIBAUD)

  PRINCIPAL INVESTIGATOR

• Yves NICOLLIN, Dr

  MG CLERMONT FERRAND (63 500 ISSOIRE)

  PRINCIPAL INVESTIGATOR

• Gilles TANGUY, Dr

  MG CLERMONT FERRAND (63 380 PONTAUMUR)

  PRINCIPAL INVESTIGATOR

• Philippe MESTRE, Dr

  MG CLERMONT FERRAND (43410 LEMPDES)

  PRINCIPAL INVESTIGATOR

• PHILIPPE ZEGANADIN, Dr

  MG CLERMONT FERRAND (63190 LEZOUX)

  PRINCIPAL INVESTIGATOR

• Véronique BERTRAND JARROUSSE, Dr

  MG CLERMONT FERRAND (6393 AUGEROLLES)

  PRINCIPAL INVESTIGATOR

• Audrey MORICE RAMAT, Dr

  MG NANTES (44118 LA CHEVROLIERE)

  PRINCIPAL INVESTIGATOR

• Sylvain FOURE, Dr

  MG NANTES (85000 LA ROCHE SUR YON)

  PRINCIPAL INVESTIGATOR

• Chrystelle PEYRON, Dr

  MG NANTES (44160 PONTCHATEAU)

  PRINCIPAL INVESTIGATOR

• Mariette RABAUD PELLETIER, Dr

  MG NANTES (85340 OLONNE SUR MER)

  PRINCIPAL INVESTIGATOR

• Elodie COSSET, Dr

  MG NANTES (85430 LES CLOUZEAUX)

  PRINCIPAL INVESTIGATOR

• Brigitte TREGOUET, Dr

  MG NANTES (85000 LA ROCHE SUR YON)

  PRINCIPAL INVESTIGATOR

• Cécile RABILLER, Dr

  MG NANTES (85430 LES CLOUZEAUX)

  PRINCIPAL INVESTIGATOR

• Cédric RAT, Dr

  MG NANTES (44000 NANTES)

  PRINCIPAL INVESTIGATOR

• Antoine DE GUIBERT, Dr

  MG RENNES (35000 RENNES)

  PRINCIPAL INVESTIGATOR

• Mathilde GUERIN, Dr

  MG RENNES (22690 PLEUDIHEN SUR RANCE)

  PRINCIPAL INVESTIGATOR

• Isabelle EZANNO, Dr

  MG RENNES (56950 CRACH)

  PRINCIPAL INVESTIGATOR

• Gilles TAPIN, Dr

  MG RENNES (35590 L'HERMITAGE)

  PRINCIPAL INVESTIGATOR

• jean- François RICONO, Dr

  MG RENNES (35560 ANTRAIN)

  PRINCIPAL INVESTIGATOR

• Laure FIQUET, Dr

  MG RENNES (35160 BRETEIL)

  PRINCIPAL INVESTIGATOR

• Hervé LE NEEL, Dr

  MG RENNES (35200 RENNES)

  PRINCIPAL INVESTIGATOR

• Stephane DUQUENNE, Dr

  MG RENNES (56240 PLOUAY)

  PRINCIPAL INVESTIGATOR

• Arnaud MAURY, Dr

  MG RENNES (35470 BAIN DE BRETAGNE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: February 25, 2020
• Study Start: April 23, 2021
• Primary Completion: April 18, 2023
• Study Completion: April 18, 2025
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

FR (1)