Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-29 @ 5:34 AM
Study NCT ID:
NCT04912804
Status:
COMPLETED
Last Update Posted:
2022-04-15
First Post:
2021-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perceived Health After Hospitalization for COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-14', 'studyFirstSubmitDate': '2021-06-02', 'studyFirstSubmitQcDate': '2021-06-02', 'lastUpdatePostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to PASS and CID in patients discharged from conventional hospitalization for COVID-19 disease', 'timeFrame': 'Through study completion, an average of 6 months'}, {'measure': 'The value of perceived health scores in patients who achieved PASS and MCII', 'timeFrame': 'Through study completion, an average of 6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19, Post-hospitalization, Disease Impact']}, 'descriptionModule': {'briefSummary': 'There are currently no precise data available on the impact of COVID-19 on the daily life of patients after hospitalization. For the moment, studies have only demonstrated a strong impact of the diagnosis on the domains of quality of life explored by the MOS-SF36 questionnaire and the PHQ-9 depression score. Concerning the impact of COVID-19 disease after conventional hospitalization, field reports indicate extremely intense fatigue and a major physical impact lasting several weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with COVID-19 discharged from a conventional short-stay hospital ward.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient\n* Patient with a diagnosis of COVID-19 confirmed by PCR and/or CT scan\n* Patient hospitalized in a short stay unit (excluding intensive care and rehabilitation) for a COVID-19 infection\n* Patient providing oral consent to participate in the study\n* Patient able to understand and answer the questionnaires used\n* Patient able to answer the questions on an electronic device and to receive requests by email and/or SMS\n* Patient who has electronic equipment at home and an Internet subscription allowing him/her to answer the questionnaires online\n\nExclusion Criteria:\n\n* Patient under guardianship, curatorship or a measure of judicial safeguard'}, 'identificationModule': {'nctId': 'NCT04912804', 'acronym': 'PRO-COVID', 'briefTitle': 'Perceived Health After Hospitalization for COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Perceived Health After Hospitalization for COVID-19', 'orgStudyIdInfo': {'id': 'DEVILLIERS AOIc 2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 Patient', 'description': 'Patient discharged from a conventional short-stay hospitalization unit.', 'interventionNames': ['Other: Questionnaires']}], 'interventions': [{'name': 'Questionnaires', 'type': 'OTHER', 'description': 'SF-12, GHQ-12 and HAQ', 'armGroupLabels': ['COVID-19 Patient']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dijon', 'country': 'France', 'facility': 'Chu Dijon Bourogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}