Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT04826757
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2021-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Coordinated Care to Reduce the Prolonged Disability Risk Among Patients Suffering From Low Back Pain in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised, controlled, cluster trial. the project is multicentered.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-11-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2021-03-03', 'studyFirstSubmitQcDate': '2021-03-29', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived inability at 1 year', 'timeFrame': 'Enrollment to 12 months follow up', 'description': 'Ratio of patient presenting improvement equal or above 4 points of Roland Morris Disability Questionnaire. The minimum value of Roland Morris Disability Questionnaire is 0 and the maximun value is 24. A higher score mean worse outcome'}], 'secondaryOutcomes': [{'measure': 'Perceived inability', 'timeFrame': 'Enrollment to 3 months follow up, Enrollment to 6 months follow up', 'description': 'Ratio of patient presenting improvement equal or above 4 points of Roland Morris Disability Questionnaire. The minimum value of Roland Morris Disability Questionnaire is 0 and the maximun value is 24. A higher score mean worse outcome'}, {'measure': 'Roland Morris Disability score over time', 'timeFrame': 'Enrollment, 3 months, 6 months, 12 months', 'description': 'Evolution of Roland Morris Disability Questionnaire over time. The minimum value is 0 and the maximun value is 24. A higher score mean worse outcome'}, {'measure': 'Pain perceived', 'timeFrame': 'Enrollment - 3 months , Enrollment - 6 months and Enrollment -12 months', 'description': 'Ratio of patients presenting improvement equal or above 2 points of numerical pain scale The minimum value is 0 and the maximun value is 10. A higher score mean worse outcome'}, {'measure': 'Numerical pain scale over time', 'timeFrame': 'Enrollment, 3 months, 6 months, 12 months', 'description': 'Evolution of numerical pain scale over time. The minimum value is 0 and the maximun value is 10. A higher score mean worse outcome'}, {'measure': 'Occupational status', 'timeFrame': 'at 3 months, 6 months and 12 months', 'description': 'Ratio of patients having an active occupation (defined by have an employment and be present at work )'}, {'measure': 'Employment rate', 'timeFrame': 'Enrollment, 3 months, 6 months, 12 months', 'description': 'Evolution of employment rate over time'}, {'measure': 'Sick leave', 'timeFrame': 'during 12 months after inclusion', 'description': 'number of sick leave days'}, {'measure': 'Improved patients', 'timeFrame': 'at 3 months, 6 months and 12 months', 'description': 'Ratio of improved patients. Improved patients is defined by patient presenting improvement equal or above 4 points of Roland Morris Disability Questionnaire and improvement equal or above 2 points of numerical pain scale and having a active occupational'}, {'measure': 'Evolution of improved patients ratio', 'timeFrame': 'Enrollment, 3 months, 6 months, 12 months', 'description': 'Evolution of improved patients ratio over time Improved patients is defined by patient presenting improvement equal or above 4 points of Roland Morris Disability Questionnaire and improvement equal or above 2 points of numerical pain scale and having a active occupational'}, {'measure': 'Mental component score of Short Form -12', 'timeFrame': 'Enrollment, 3 months, 6 months, 12 months', 'description': 'Evolution of mental scores over time The mental component score is determined by 4 categories of Short Form -12. The minimum value of each category is 0 and the maximun value is 100. A higher score mean better outcome'}, {'measure': 'Physical component score of Short Form -12', 'timeFrame': 'Enrollment, 3 months, 6 months, 12 months', 'description': 'Evolution of physical scores over time. The physical component score is determined by 4 categories of Short Form -12. The minimum value of each category is 0 and the maximun value is 100. A higher score mean better outcome'}, {'measure': 'Occupational component score of Fear Avoidance Beliefs Questionnaire', 'timeFrame': 'Enrollment, 3 months, 12 months', 'description': 'Evolution of occupational component score over time. Occupational component is assessed using the Fear Avoidance Beliefs Questionnaire.\n\nThe minimum value is 0 and the maximun value is 42. A higher score mean worse outcome'}, {'measure': 'Physical activity component score of Fear Avoidance Beliefs Questionnaire', 'timeFrame': 'Enrollment, 3 months, 12 months', 'description': 'Evolution of physical activity component score over time. Physical activity component is assessed using the Fear Avoidance Beliefs Questionnaire.\n\nThe minimum value is 0 and the maximun value is 24. A higher score mean worse outcome'}, {'measure': 'Anxiety component score of Hospital Anxiety and Depression Scale', 'timeFrame': 'Enrollment 3 months, 12 months', 'description': 'Evolution of Anxiety score over time Anxiety Component is assessed using the Hospital Anxiety and Depression Scale The minimum value is 0 and the maximun value is 21. A higher score mean worse outcome'}, {'measure': 'Depression component score of Hospital Anxiety and Depression Scale', 'timeFrame': 'Enrollment, 3 months, 12 months', 'description': 'Evolution of Depression score over time Depression component is assessed using the Hospital Anxiety and Depression Scale The minimum value is 0 and the maximun value is 21. A higher score mean worse outcome'}, {'measure': 'Coordination care score of Patient Centered Coordination by a Care Team questionnaire', 'timeFrame': 'Enrollment, 3 months, 12 months', 'description': 'Evolution of coordination care score over time This score is assessed by using Patient Centered Coordination by a Care Team questionnaire.\n\nThe minimum value is 0 and the maximun value is 42. A higher score mean better outcome'}, {'measure': 'GP satisfaction related to patient care', 'timeFrame': 'T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion)', 'description': 'Evolution of GP satisfaction using an numerical scale The minimum value is 0 and the maximun value is 10. A higher score mean worse outcome'}, {'measure': 'Physiotherapist satisfaction related to patient care', 'timeFrame': 'T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion)', 'description': 'Evolution of physiotherapist satisfaction using an numerical scale The minimum value is 0 and the maximun value is 10. A higher score mean worse outcome'}, {'measure': 'Professionals trained for intervention', 'timeFrame': 'Baseline intervention formations', 'description': 'number of professionals trained for intervention'}, {'measure': 'Biomechanical component score of Pain Attitudes and Beliefs score - for intervention physiotherapists', 'timeFrame': 'T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion)', 'description': 'Evolution of Biomechanical component score for intervention physiotherapists. Biomechanical component is assessed using the Pain Attitudes and Beliefs Score. The minimum value is 10 and the maximun value is 60. A higher score mean worse outcome'}, {'measure': 'Biopsychosocial component score of Pain Attitudes and Beliefs score - for intervention physiotherapists', 'timeFrame': 'T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion)', 'description': 'Evolution of Biopsychosocial component score for intervention physiotherapists. Biopsychosocial component is assessed using the Pain Attitudes and Beliefs Score.The minimum value is 9 and the maximun value is 54. A higher score mean better outcome'}, {'measure': 'Biopsychosocial component score of Pain Attitudes and Beliefs score - for GPs', 'timeFrame': 'T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion)', 'description': 'Evolution of Biopsychosocial component score for GPs. Biopsychosocial component is assessed using the Pain Attitudes and Beliefs Score.The minimum value is 9 and the maximun value is 54. A higher score mean better outcome'}, {'measure': 'Biomechanical component score of Pain Attitudes and Beliefs score - for GPs', 'timeFrame': 'T0 = baseline (cluster initiation); T1 = 1 year (6 months after inclusion of the 5th cluster patient); T2 = through study completion, an average of 3 years (12 months after the last cluster patient inclusion)', 'description': 'Evolution of Biomechanical component score for GPs. Biomechanical component is assessed using the Pain Attitudes and Beliefs Score. The minimum value is 10 and the maximun value is 60. A higher score mean worse outcome'}, {'measure': 'Professional dialogues', 'timeFrame': 'during the 12 months of follow up', 'description': 'Existence and types of dialogues between GP and other professionals'}, {'measure': 'Number of consultations or sessions', 'timeFrame': 'during the 12 months of follow up', 'description': 'Number of consultations or sessions'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '37409270', 'type': 'DERIVED', 'citation': 'Ramond-Roquin A, Begue C, Vizzini J, Chhor S, Bouchez T, Parot-Schinkel E, Loiez A, Petit A, Ghali M, Peurois M, Bouton C. Effectiveness of coordinated care to reduce the risk of prolonged disability among patients suffering from subacute or recurrent acute low back pain in primary care: protocol of the CO.LOMB cluster-randomized, controlled study. Front Med (Lausanne). 2023 Jun 20;10:1156482. doi: 10.3389/fmed.2023.1156482. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': "Common low back pain affects about 23% of general population and can be associated with psychosocial difficulties and prolonged inability to work. Its management in France mainly depends on general practioners, and sometime on physiotherapists.\n\nA coordinated care between general practioners, physiotherapists and occupational health services would help to improve the care pathway for patients and health professionals.\n\nThe main objective is to assess the impact of coordinated primary care and deployed at the territories' level, in subacute or acute recurrent low back pain patients in comparison with the standard care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient consulting an investigator GP for subacute low back pain or acute recurrent low back pain\n* Patient with occupational activity (including sick leave)\n* Patient depending of occupational health service\n* Obtaining the signature of the consent to participate in this trial\n* Patient Registered with social security scheme\n\nNon-inclusion Criteria:\n\n* Specific low back pain (fracture, infection, osteoporosis, inflammatory disease, tumor)\n* Low back pain with sciatic, cruralgia\n* Contraindication to active reeducation\n* Impossibility to follow up during 12 months\n* Patient planning to retire within the 12 months following the enrollment\n* Disability to write or read french\n* Adult patient protected under the law (guardianship),\n* Pregnant, breastfeeding or parturient women\n* Persons deprived of their liberty by judicial or administrative decision\n* Persons subject to legal protection measures\n* Persons unable to consent\n* Persons on coercion psychiatric care\n* Physiotherapy by a physiotherapist who don't participate in this trial"}, 'identificationModule': {'nctId': 'NCT04826757', 'acronym': 'COLOMB', 'briefTitle': 'Effectiveness of Coordinated Care to Reduce the Prolonged Disability Risk Among Patients Suffering From Low Back Pain in Primary Care', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Effectiveness of Coordinated Care to Reduce the Risk of Prolonged Disability Among Patients Suffer From Subacute or Recurrent Acute Low Back Pain in Primary Care', 'orgStudyIdInfo': {'id': '2020-A01039-30'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'standard care', 'description': 'standard care for low back pain management by general practioners (GPs). the physiotherapist and occupational health services can be solicited independently by the patient or GP.'}, {'type': 'EXPERIMENTAL', 'label': 'coordinated care', 'description': "Coordinated care between general practioners, physiotherapist and occupational health services.\n\nAn intervention training will be performed before the start of the study for any care professional's to elaborate coordination tools and have an active communication.", 'interventionNames': ['Other: Coordinated care']}], 'interventions': [{'name': 'Coordinated care', 'type': 'OTHER', 'description': 'Coordinated care between general practioners; physiotherapists and occupational health services.\n\nEarly contact with occupational health service by the general practioner and use of occupational retention tool Active physiotherapy (Individual active, intensive and regular rehabilitation program with 15 sessions of 1 hour, at a rate of 2 or 3 sessions per week)', 'armGroupLabels': ['coordinated care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bonchamp-lès-Laval', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ghislaine JUDALET, MD', 'role': 'CONTACT', 'email': 'dr.gh.judalet.illand@orange.fr', 'phone': '0243903280', 'phoneExt': '+33'}, {'name': 'Cédric HAMON, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Annelore DEFOIN, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Margaux RIPAUD, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cluster Bonchamp', 'geoPoint': {'lat': 48.07379, 'lon': -0.70195}}, {'city': 'Breteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laure FIQUET', 'role': 'CONTACT', 'email': 'laure.fiquet@univ-rennes1.fr', 'phone': '0299615926', 'phoneExt': '+33'}, {'name': 'François TANGUY, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Béatrice NEGARET, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Luc GUICHARD, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Béatrice ALLARD COUALAN, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Roxane MORIN, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cluster Vaunoise', 'geoPoint': {'lat': 48.1452, 'lon': -1.89864}}, {'city': 'Brûlon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'ANGOULVANT Cécile, MD', 'role': 'CONTACT', 'email': 'cecile.angoulvant@univ-angers.fr', 'phone': '0243956299', 'phoneExt': '+33'}, {'name': 'Alexandre DE BARBERIN-BARBERINI, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Paul BOULARD, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Claire GASNIER, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pauline LEFEUVRE, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cluster BRULON', 'geoPoint': {'lat': 47.9686, 'lon': -0.23484}}, {'city': 'Château-Gontier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Héloïse ROGER, MD', 'role': 'CONTACT', 'email': 'docteur.roger.heloise@gmail.com', 'phone': '024370151506', 'phoneExt': '+33'}, {'name': 'Thibault BARBIER, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pierre DELAHAYE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Claire HAMARD, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Audrey LEPY, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eric MICHAUD, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marie Christine SALVATO, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cluster Château Gontier', 'geoPoint': {'lat': 47.82705, 'lon': -0.70512}}, {'city': 'Châteauneuf-sur-Sarthe', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christine RENIER TISNE, MD', 'role': 'CONTACT', 'email': 'christine.renier@orange.fr', 'phone': '0478080400', 'phoneExt': '+33'}, {'name': 'Cyril BEGUE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sylvie MARTEAU, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anne Charlotte ROCFORT, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Isabelle VIGUE-BOURREAU, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yoldi BRETT, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cluster Châteauneuf sur Sarthe / Morannes', 'geoPoint': {'lat': 47.68087, 'lon': -0.48848}}, {'city': 'Clisson', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gilles BARNABE, MG', 'role': 'CONTACT', 'email': 'gilles.barnabe@wanadoo.fr', 'phone': '0240540939', 'phoneExt': '+33'}, {'name': 'Christophe ALLAIN, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Didier JUTEL, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elise KRAI-ASGARALY, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sabine NAOUR-LEROY, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Emilie BEAGHE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Agnés PLOTEAU, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sarah NOEL, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cluster Clisson', 'geoPoint': {'lat': 47.0871, 'lon': -1.28297}}, {'city': 'Conlie', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jessica GUELFF, MD', 'role': 'CONTACT', 'email': 'docteur.guelff@gmail.com', 'phone': '0243209520', 'phoneExt': '+33'}, {'name': 'Guillaume FETIVEAU, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Noémie QUEANT, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christèle TOURNELLE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Arthur VIGNAUD, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cluster Conlie', 'geoPoint': {'lat': 48.12261, 'lon': -0.01666}}, {'city': 'Craon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aline RAMOND ROQUIN, MD-PHD', 'role': 'CONTACT', 'email': 'aline.ramond@univ-angers.fr', 'phone': '0253945252', 'phoneExt': '+33'}, {'name': 'Anne PLESSIS, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Charlene LESAGE BESNIER, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jean Michel MONNIER, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lydie GENDRY ROSSIGNOL, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maryline MERIENNE COUSSE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Julien BERTRAND, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pascal GENDRY, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rebecca NAUD, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marine GESLOT, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Florie ALGRAIN, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cluster Craon Renaze Cosse', 'geoPoint': {'lat': 47.84811, 'lon': -0.95002}}, {'city': 'Entrammes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Matthieu PEUROIS, MD', 'role': 'CONTACT', 'email': 'matthieu.peurois@univ-angers.fr', 'phone': '0688895476', 'phoneExt': '+33'}, {'name': 'Thi phi Bach NGUYEN, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Josselin DELAHAYE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Olivier PIVETEAU, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Romain CLISSON, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cluster Entrammes Laval', 'geoPoint': {'lat': 47.9993, 'lon': -0.71541}}, {'city': 'La Roche-sur-Yon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sandrine Sandrine, MD', 'role': 'CONTACT', 'email': 'sandrine.hild@univ-nantes.fr', 'phone': '0251361547', 'phoneExt': '+33'}, {'name': 'Amandine PELLETIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jeanne QUERE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Angèle DUCRET, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cluster Roche sur Yon', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean Pascal FOURNIER, MD', 'role': 'CONTACT', 'email': 'jean-pascal.fournier@univ-nantes.fr', 'phone': '0240730602', 'phoneExt': '+33'}, {'name': 'Laure GEGAUFF, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thomas JAN, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Héloïse SCHMELTZ, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tom LUCAS, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cluster Chantenay', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Quévert', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'CHAPRON ANTHONY, MD', 'role': 'CONTACT', 'email': 'anthony.chapron@univ-rennes1.fr', 'phone': '0296870076', 'phoneExt': '+33'}, {'name': 'Jannice COUDERT, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Florence ADELINE DUFLOT, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Samuel ROGER, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cluster Dinan / Quévert / Plouasne', 'geoPoint': {'lat': 48.46391, 'lon': -2.08663}}, {'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sidonie CHHOR, MD', 'role': 'CONTACT', 'email': 'sidonie.chhor@univ-rennes1.fr', 'phone': '0299676733', 'phoneExt': '+33'}, {'name': 'Muriel CABOTTE CARILLON, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Virginie MIMS LAROME, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pierre LE DOUARON, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lisa LOUIS, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Carole PONTHUS-AUFFRET, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cluster Rennes Beauregard', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuel ALLORY, MD', 'role': 'CONTACT', 'email': 'emmanuel.allory@univ-rennes1.fr', 'phone': '0664910897', 'phoneExt': '+33'}, {'name': 'Caroline JEHANNO, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anna JARNO-JOSSE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Romain NIFENECKER, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hoël CHARBONNEL, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cluster Rennes Villejean', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Roquefort-les-Pins', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Cluster Les Collines', 'geoPoint': {'lat': 43.67265, 'lon': 7.05652}}, {'city': 'Saint-Florent-le-Vieil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gwenaël BEAUVINEAU, MD', 'role': 'CONTACT', 'email': 'gwenael.bvn84@hotmail.com', 'phone': '0241725422', 'phoneExt': '+33'}, {'name': 'Jean BIMIER, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pauline DES BOUILLONS, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Laure JANUS, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lila TILLARD, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Julien VERRIERE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lucile BOURLOT, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cluster St Florent, Mauges, Possonnière', 'geoPoint': {'lat': 47.36069, 'lon': -1.01515}}, {'city': 'Savenay', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérôme MICHENAUD, MD', 'role': 'CONTACT', 'email': 'jermiche@gmail.com', 'phone': '0272005555', 'phoneExt': '+33'}, {'name': 'Marine GARDY, MG', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Karine AH-FAT, MG', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cluster Savenay', 'geoPoint': {'lat': 47.36106, 'lon': -1.94206}}, {'city': 'Segré', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphane FREZE, MD', 'role': 'CONTACT', 'email': 'stephane.freze@wanadoo.fr', 'phone': '0241947540', 'phoneExt': '+33'}, {'name': 'Héloise GISLARD, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gilles GUSTIN, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jérôme NUEL, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marjorie HEBERT, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Virginie HEMERY, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Audrey LILLE, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cluster SEGRE', 'geoPoint': {'lat': 47.68672, 'lon': -0.87268}}, {'city': 'Trélazé', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine DE CASABIANCA, MD', 'role': 'CONTACT', 'email': 'catherine.decasabianca@univ-angers.fr', 'phone': '0241473344', 'phoneExt': '+33'}, {'name': 'Sandra NETO-ANNE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Clément GUINEBERTEAU, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Carène EDIN, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Héloïse PREAU, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marie LA TOUR GAUVRIT, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cluster Angers- Trélazé', 'geoPoint': {'lat': 47.44629, 'lon': -0.46652}}, {'city': 'Vence', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'POUILLON MAUD, MD', 'role': 'CONTACT', 'email': 'maud.pouillon@unice.fr', 'phone': '0695882985', 'phoneExt': '+33'}, {'name': 'Fabrice GASPERINI, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Emilie SCALABRE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Raphaëlle VIDAL, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Charlotte BRUN, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cluster Vence', 'geoPoint': {'lat': 43.72254, 'lon': 7.11183}}], 'centralContacts': [{'name': 'Aline RAMOND ROQUIN, MD-PHD', 'role': 'CONTACT', 'email': 'aline.ramond@univ-angers.fr', 'phone': '0241735867', 'phoneExt': '+33'}, {'name': 'Anthea LOIEZ', 'role': 'CONTACT', 'email': 'anthea.loiez@univ-angers.fr', 'phone': '0241735867', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Aline RAMOND ROQUIN, MD-PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Family Medicine - University of Angers'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.', 'ipdSharing': 'YES', 'description': 'Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.', 'accessCriteria': 'The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}