Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2026-01-21 @ 12:57 AM
Study NCT ID:
NCT04544761
Status:
UNKNOWN
Last Update Posted:
2023-10-18
First Post:
2020-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resilience in Persons Following Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-16', 'studyFirstSubmitDate': '2020-09-04', 'studyFirstSubmitQcDate': '2020-09-09', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health Questionnaire Surveys', 'timeFrame': '1 day (Single time point)', 'description': 'Short Form-12 Health Survey \\[30-70\\] 50 indicates US average, values higher than 50 indicate better outcomes'}], 'primaryOutcomes': [{'measure': 'Themes Survey', 'timeFrame': '1 day (Single time point)', 'description': 'Common themes from the structured interviews'}], 'secondaryOutcomes': [{'measure': 'Resilience', 'timeFrame': '1 day (Single time point)', 'description': 'Measure of resilience from Connor-Davidson Resilience Scale \\[0-40\\], low score indicates greater resilience'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resilience'], 'conditions': ['Spinal Cord Injuries']}, 'referencesModule': {'references': [{'pmid': '38649756', 'type': 'DERIVED', 'citation': 'Roth EJ, Lovell L, Barry A. Perspectives on factors influencing quality of life in persons with long-term spinal cord injury: a qualitative study. Spinal Cord. 2024 Jun;62(6):343-347. doi: 10.1038/s41393-024-00991-w. Epub 2024 Apr 22.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to quantify resilience in survivors of a spinal cord injury. The study will consist of structured interviews and self-reported surveys. We will look for common themes between participants at different stages of injury (1-5 years, 5-15 years, \\>15 Years).', 'detailedDescription': 'The goal of this project is to broaden the understanding of the lived experience of aging with a disability, from the perspectives of individuals with physical disabilities resulting from spinal cord injury (SCI). The specific objectives of this project are to:\n\n1. Learn how people with SCI attain and maintain optimal quality of life as they age.\n2. Understand how people with SCI develop resilience as they grow older.\n3. Understand how individual quality of life is related to the degree and mechanism of resilience among people with SCI.\n4. Learn which resources and practices have been most helpful and useful to people with SCI as they age with their disability.\n5. Assess personal, behavioral, and environmental factors that contribute to resilience and quality of life among people aging with SCI.\n6. Refine and confirm a holistic model for the relationships among the concepts of resilience, quality of life, and person-centered factors (resources, behaviors).\n\nThrough in-depth interviews and detailed surveys, we will explore how people with SCI attain and maintain optimal quality of life as they age, and how their quality of life relates to resiliency as they traverse the path of aging with SCI. We will explore with participants the resources and practices that have been most helpful and useful to them as they age with their disability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Persons who have experienced spinal cord injury at least 1 year prior to enrollment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 years old\n* History of Traumatic Spinal Cord Injury at least 1 year prior\n* Ability to self-report on factors affecting health and well being Exclusion Criteria\n* Progressive Spinal Cord Injury'}, 'identificationModule': {'nctId': 'NCT04544761', 'briefTitle': 'Resilience in Persons Following Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Shirley Ryan AbilityLab'}, 'officialTitle': 'Resilience in People Following Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'STU00213014'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1-5 Years post', 'description': 'Persons with Spinal Cord Injury occurring between 1-5 years prior', 'interventionNames': ['Other: Structured Interview']}, {'label': '5-15 Years post', 'description': 'Persons with Spinal Cord Injury occurring between 5-15 years prior', 'interventionNames': ['Other: Structured Interview']}, {'label': '>15 Years post', 'description': 'Persons with Spinal Cord Injury occurring at least 15 years prior', 'interventionNames': ['Other: Structured Interview']}], 'interventions': [{'name': 'Structured Interview', 'type': 'OTHER', 'description': 'Structured interview with research staff about your experience living with spinal cord injury', 'armGroupLabels': ['1-5 Years post', '5-15 Years post', '>15 Years post']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Shirley Ryan AbilityLab', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Elliot Roth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shirley Ryan AbilityLab'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shirley Ryan AbilityLab', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kiwanis Neurological Research Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Medical Director, Brain Innovation Center', 'investigatorFullName': 'Elliot Roth', 'investigatorAffiliation': 'Shirley Ryan AbilityLab'}}}}