Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-03-05 @ 5:41 PM
Study NCT ID:
NCT04409535
Status:
COMPLETED
Last Update Posted:
2024-10-18
First Post:
2020-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of the COVID-19 Health Emergency on Biopsychosocial Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-06', 'size': 391258, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-26T16:49', 'hasProtocol': True}, {'date': '2020-05-06', 'size': 239647, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-15T12:12', 'hasProtocol': False}, {'date': '2020-05-05', 'size': 143034, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-04-26T16:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-15', 'studyFirstSubmitDate': '2020-05-11', 'studyFirstSubmitQcDate': '2020-05-28', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'World Health Organization Quality of Life-Brief Scale', 'timeFrame': 'From enrollment until post-event (Feb. 2021)', 'description': 'participant responses about quality of life during COVID-19 emergency'}], 'secondaryOutcomes': [{'measure': 'Open-ended Interview', 'timeFrame': 'From enrollment until post-event (Feb. 2021)', 'description': 'Participants responses to open-ended interview questions regarding alteration in daily life routines'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quality of Life', 'Rural Community', 'COVID-19'], 'conditions': ['Activities', 'Mental Health Issue', 'Life Style']}, 'descriptionModule': {'briefSummary': "There is a critical need to determine the impact of the COVID-19 emergency on the comprehensive well-being of people as they are living through the emergency and sequelae of the emergency period. The research team is requesting National Institutes of Health funding with the goal to investigate rural vs. urban living people's response to the crisis and its impact using mixed methods research.", 'detailedDescription': 'The state of New Mexico and the entire nation have entered an unprecedented health emergency created by the COVID-19 virus; affecting the lives of all people, many of whom were significantly unprepared for the disruptions the emergency created in daily life. Rural residents are at increased risk from effects of the emergency due to numerous disadvantages as compared to urban living people (i.e. critical care access, food insecurity, social isolation). Very little is known about how people are living through a national emergency event affecting all people of the nation. Therefore, a significant gap in knowledge exists: 1. How are rural-living vs. urban-living people responding physically and mentally to the crisis? 2. What strategies of resilience are employed by people living in rural vs. urban counties? 3. What are perceptions of access to critical supplies and services in urban vs. rural counties; 4. How is the availability and use of technology used for news, reliable information, and communication? and 5. Use of time: what alterations in daily life self-care, care of others, commerce, and valued routines in urban vs. rural counties are occurring?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Urban or rural living residents of New Mexico currently living under the "stay at home" emergency secondary to COVID-19', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Urban and rural living residents of New Mexico, any gender, gender identity, any ethnic origin, any health status (healthy, chronic, disabled), and adult age from 18-85\n\nExclusion Criteria:\n\n* Non-New Mexico residents, adults unable to give consent due to cognition or incarceration status'}, 'identificationModule': {'nctId': 'NCT04409535', 'briefTitle': 'Effects of the COVID-19 Health Emergency on Biopsychosocial Health', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'Effects of the COVID-19 Health Emergency on the Biopsychosocial Health of Rural Residents of New Mexico Using Mixed Methods Research', 'orgStudyIdInfo': {'id': '20-266'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rural Living Community Member', 'description': 'Adult residents of a New Mexico rural county (as federally designated)', 'interventionNames': ['Other: WHOQOL-BREF survey']}, {'label': 'Urban/Suburban Living Community Member', 'description': 'Comparison group: adult resident of a New Mexico urban/suburban city or town (as federally designated)', 'interventionNames': ['Other: WHOQOL-BREF survey']}], 'interventions': [{'name': 'WHOQOL-BREF survey', 'type': 'OTHER', 'otherNames': ['Personal Interview'], 'description': 'Participants will be surveyed and interviewed about their perceptions regarding COVID-19 health emergency', 'armGroupLabels': ['Rural Living Community Member', 'Urban/Suburban Living Community Member']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Department of Pediatrics', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Carla Wilhite, DOT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'March 2021 (tentative) and will be available for three years', 'ipdSharing': 'YES', 'description': 'De-identified, aggregated data will be available', 'accessCriteria': 'Written request from other academic research university'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Carla S. Wilhite', 'investigatorAffiliation': 'University of New Mexico'}}}}