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

Last updated on July 2021

Recruitment

Recruitment Status: Not yet recruiting
Estimated Enrollment: Same as current

Summary

Conditions: Peripheral Arterial Disease
Type: Interventional
Phase: Not Applicable
Design: Allocation: RandomizedIntervention Model: Factorial AssignmentIntervention 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. Masking: None (Open Label)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.Primary Purpose: Prevention

Participation Requirements

Age: Between 50 years and 90 years
Gender: Both males and females

Description

Not Provided

Tracking Information

NCT #

NCT04283565

Collaborators

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

Investigators

Principal Investigator: Sebastien BRUEL, Dr CRMG SAINT ETIENNE Principal Investigator: Clarisse 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 Principal Investigator: Emmanuel ALLORY,, Dr CRMG RENNES Principal Investigator: Florent CROUZET,, Dr MG SAINT ETIENNE (42210 Montrond-les-Bains) 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: Romain LAMOTTE, Dr MG SAINT ETIENNE (69590 SAINT SYMPHORIEN SUR COISE) Principal Investigator: Hervé BONNEFOND, Dr MG SAINT ETIENNE (42000 SAINT ETIENNE) Principal Investigator: Alexandre BRULET, Dr MG SAINT ETIENNE (42300 ROANNE) 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: Lucas BEURTON- COURAUD,, Dr MG BREST (29190 PLEYBEN) 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: Syndie CANN, Dr MG BREST (29 520 CHATEAUNEUF DU FAVU) 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: Anne DONCIEUX, Dr MG RENNES (56500 MOREAC) Principal Investigator: Hervé LE NEEL, Dr MG RENNES (35200 RENNES) Principal Investigator: Stephane DUQUENNE, Dr MG RENNES (56240 PLOUAY) Principal Investigator: Boris LAGOUTTE, Dr 35250 ST AUBIN D'AUBIGNE