Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-05 @ 6:04 PM
Study NCT ID:
NCT02214056
Status:
COMPLETED
Last Update Posted:
2015-05-06
First Post:
2014-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Unit Screening of Pathologies Associated With Chronic Diseases - Feasibility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018579', 'term': 'Patient Selection'}], 'ancestors': [{'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-05', 'studyFirstSubmitDate': '2014-08-07', 'studyFirstSubmitQcDate': '2014-08-08', 'lastUpdatePostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of eligible patients who actually received the mobile team exam', 'timeFrame': 'Day of mobile team exam (day 0)'}], 'secondaryOutcomes': [{'measure': 'Observance: percentage of patients included that actually received the balance sheet', 'timeFrame': 'Day of mobile team exam (day 0)'}, {'measure': 'Time in days between making the appointment by the general practitioner and the mobile team exam', 'timeFrame': 'Day of mobile team exam (day 0)'}, {'measure': 'Average per patient time necessary to carry out the mobile team exam', 'timeFrame': 'Day of mobile team exam (day 0)'}, {'measure': 'Average time required for the patient to fill out questionnaires', 'timeFrame': 'Day of mobile team exam (day 0)'}, {'measure': 'Percentage of complete mobile team exams, that is to say in which all the data and all the variables have been collected and interpreted', 'timeFrame': 'Day of mobile team exam (day 0)'}, {'measure': 'Percentage of GPs who participated in the study', 'timeFrame': 'Day of mobile team exam (day 0)'}, {'measure': 'Percentage of mobile team exams in which one or more comorbidities was discovered', 'timeFrame': 'Day of mobile team exam (day 0)'}, {'measure': 'GP and patient acceptability of the mobile team exam', 'timeFrame': 'Day of mobile team exam (day 0)', 'description': 'Visual analog scales (ranging from 0 to 10) for access, delays, organization and satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mobile screening team', 'feasibility'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'Type II Diabetes', 'Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to assess the feasibility of standardized screening for comorbidities among patients with one or more of three chronic diseases (diabetes, COPD, atherosclerosis) by a mobile unit at times and localities under-served by health actors.', 'detailedDescription': 'The investigators secondary objectives include assessing patient and GP satisfaction in relation to the mobile screening team.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of patients at least 50 years of age with a chronic disease (COPD, Type II diabetes, atherosclerosis) recruited by one of the GP investigators.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must have given his/her informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n* The patient has one or more of the following three diseases: (1) chronic obstructive pulmonary disease (COPD); (2) type II diabetes; (3) atherosclerosis.\n\nExclusion Criteria:\n\n* The patient is participating in another study\n* The patient is in an exclusion period determined by a previous study\n* The patient is under judicial protection, under tutorship or curatorship\n* The patient refuses to sign the consent\n* It is impossible to correctly inform the patient\n* There is a need to take urgent therapeutic care in the opinion of the general practitioner\n* The patient has received within the past year, a full examination including Doppler assessment of supra-aortic arteries, abdominal aorta and lower limbs; the patient has received a measure of the ankle-brachial index at the toe.'}, 'identificationModule': {'nctId': 'NCT02214056', 'acronym': 'DéProPAss', 'briefTitle': 'Mobile Unit Screening of Pathologies Associated With Chronic Diseases - Feasibility', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Mobile Unit Screening of Pathologies Associated With Chronic Diseases - Part I Feasibility', 'orgStudyIdInfo': {'id': 'LOCAL/2013/DC-02'}, 'secondaryIdInfos': [{'id': '2013-A01703-42', 'type': 'OTHER', 'domain': 'RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'The study population', 'description': 'There is only one group in this study. Please see the inclusion/exclusion criteria.\n\nIntervention: Patient recruitment Intervention: Mobile team exam', 'interventionNames': ['Other: Patient recruitment', 'Procedure: Mobile team exam']}], 'interventions': [{'name': 'Patient recruitment', 'type': 'OTHER', 'description': 'Participating general practitioners (GPs) will inform and recruit participants from among regular patient consults. Using the provided web tools, GPs will organize a visit with the mobile team that fits the needs of the patient.', 'armGroupLabels': ['The study population']}, {'name': 'Mobile team exam', 'type': 'PROCEDURE', 'description': 'Each patient enrolled will receive a standardized assessment in one locality, made in about two hours, and comprising:\n\nquestionnaire responses, a complete physical exam, a 12-lead ECG, spirometry before and after administration of β2-agonists, an arterial Doppler ultrasound (carotid and abdominal), ankle-brachial index (systolic pressure at the toe).\n\nAt the end of two hours, each patient will evaluate their satisfaction using a survey of acceptability and leave with a full report to the attention of their general practitioner (copy sent to Physician if needed) detailing the results of the different examinations.', 'armGroupLabels': ['The study population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30160', 'city': 'Bessèges', 'country': 'France', 'facility': 'Cabinet Médical - 47 rue de la République', 'geoPoint': {'lat': 44.29174, 'lon': 4.1004}}, {'zip': '30160', 'city': 'Bessèges', 'country': 'France', 'facility': 'Centre de Santé Médical', 'geoPoint': {'lat': 44.29174, 'lon': 4.1004}}, {'zip': '34190', 'city': 'Ganges', 'country': 'France', 'facility': 'Centre médical des Olivettes', 'geoPoint': {'lat': 43.93419, 'lon': 3.70797}}, {'zip': '30110', 'city': 'La Grand-Combe', 'country': 'France', 'facility': 'Cabinet Médical - 5 rue Abbé Masson', 'geoPoint': {'lat': 44.2116, 'lon': 4.03001}}, {'zip': '30460', 'city': 'Lasalle', 'country': 'France', 'facility': 'Cabinet Médical - 154 Place de la Poste', 'geoPoint': {'lat': 44.04573, 'lon': 3.85244}}, {'zip': '30460', 'city': 'Lasalle', 'country': 'France', 'facility': 'Cabinet Médical - Les Glycines', 'geoPoint': {'lat': 44.04573, 'lon': 3.85244}}, {'zip': '30410', 'city': 'Molières-sur-Cèze', 'country': 'France', 'facility': 'Cabinet Médical - Pont de Grammal', 'geoPoint': {'lat': 44.25995, 'lon': 4.15855}}, {'zip': '30000', 'city': 'Nîmes', 'country': 'France', 'facility': 'Cabinet Médical - 9 rue Racine', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '30260', 'city': 'Quissac', 'country': 'France', 'facility': 'Cabinet Médical - 15 rue du Lac', 'geoPoint': {'lat': 43.91073, 'lon': 4.00102}}, {'zip': '30500', 'city': 'Saint-Ambroix', 'country': 'France', 'facility': "Cabinet Médical - 36 place de l'Esplanade", 'geoPoint': {'lat': 44.26059, 'lon': 4.19817}}, {'zip': '30960', 'city': 'Saint-Florent-sur-Auzonnet', 'country': 'France', 'facility': 'Centre Médical La Cantonnade', 'geoPoint': {'lat': 44.24166, 'lon': 4.11151}}, {'zip': '30270', 'city': 'Saint-Jean-du-Gard', 'country': 'France', 'facility': 'Cabinét Médical - 9 rue Villeneuve', 'geoPoint': {'lat': 44.10505, 'lon': 3.88584}}, {'zip': '30610', 'city': 'Sauve', 'country': 'France', 'facility': 'Cabinet Médical - 7 bis avenue Rhin Danube', 'geoPoint': {'lat': 43.94208, 'lon': 3.94935}}], 'overallOfficials': [{'name': 'David Costa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}