Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT04351633
Status:
COMPLETED
Last Update Posted:
2020-12-11
First Post:
2020-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psychological Impact of Quarantine in Osteoporosis Patient During COVID-19 Outbreak
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-10', 'studyFirstSubmitDate': '2020-04-15', 'studyFirstSubmitQcDate': '2020-04-15', 'lastUpdatePostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of patient with feeling of disabilities', 'timeFrame': 'maximum 1 week from baseline on'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psychological impact', 'COVID-19'], 'conditions': ['Sars-CoV2', 'Osteoporosis']}, 'descriptionModule': {'briefSummary': 'In the context of quarantine with COVID-19, we wish to study the experience and psychological impact in adult patients living with osteoporosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'osteoporosis patient will be interviewed par internet questionnaire (patient association / AFLAR)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with osteoporosis\n* Patient in confinement\n* Patient with sufficient understanding of the French language\n\nExclusion Criteria:\n\n* Non adult patient\n* patient without quarantine'}, 'identificationModule': {'nctId': 'NCT04351633', 'acronym': 'OsPsyCOVID', 'briefTitle': 'Psychological Impact of Quarantine in Osteoporosis Patient During COVID-19 Outbreak', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Psychological Impact of Quarantine in Osteoporosis Patient During COVID-19 Outbreak', 'orgStudyIdInfo': {'id': '2020_31'}, 'secondaryIdInfos': [{'id': '2020-A00911-38', 'type': 'OTHER', 'domain': 'ID-RCB number,ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'osteoporosis patient', 'interventionNames': ['Other: questionnaire assesment']}], 'interventions': [{'name': 'questionnaire assesment', 'type': 'OTHER', 'description': 'questionnaire assesment', 'armGroupLabels': ['osteoporosis patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hopital Roger Salengro, CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Bernard Cortet, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}