Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-03-03 @ 4:15 AM
Study NCT ID:
NCT03028493
Status:
COMPLETED
Last Update Posted:
2018-01-04
First Post:
2017-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Increasing the Accessibility of a Falls Prevention Intervention for Community Dwelling Older Adults With Low Vision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015354', 'term': 'Vision, Low'}], 'ancestors': [{'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Three individuals not involved in intervention delivery will complete pre-post measures.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-02', 'studyFirstSubmitDate': '2017-01-18', 'studyFirstSubmitQcDate': '2017-01-19', 'lastUpdatePostDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in knowledge of falls prevention', 'timeFrame': 'Pre and post (2 weeks after start of intervention delivery)', 'description': '10 multiple choice questions based on the SAFE intervention content'}], 'secondaryOutcomes': [{'measure': 'Short Physical Performance Battery', 'timeFrame': 'Pre', 'description': 'Measures of balance, gait, and sit to stand'}, {'measure': 'PROMIS Depression Scale', 'timeFrame': 'Pre', 'description': 'Measures depression'}, {'measure': 'PROMIS Participation Scale', 'timeFrame': 'Pre', 'description': 'Measures daily participation'}, {'measure': 'PROMIS Global Health', 'timeFrame': 'Pre', 'description': 'Measures general health'}, {'measure': 'UAB Life-Space Inventory', 'timeFrame': 'Pre', 'description': 'Measures places travelled within past month'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Vision', 'Fall']}, 'descriptionModule': {'briefSummary': 'This study serves to test a previously evaluated falls prevention intervention recommended by the Centers for Disease Control and Prevention, entitled the Study of Accidental Falls in the Elderly (SAFE) Health Behavior and Exercise Intervention, to evaluate if the intervention is accessible to older adults with low vision receiving services from the Southeastern Blind Rehabilitation Center (SBRC). This study also serves to pilot a version of the SAFE intervention that has been adapted to be accessible for individuals with low vision at SBRC.', 'detailedDescription': 'This study serves to compare the comprehension and retention of individuals completing a version of the SAFE falls prevention intervention adapted for low vision versus individuals receiving the original intervention. One group of participants will complete the standard SAFE intervention format while another group will complete the same intervention with written materials adapted for those with vision loss. One intervention (either standard or adapted SAFE program) will be delivered at a time. The SAFE intervention is comprised of four, 90-minute group classes that address environmental, behavioral, and physical falls risk factors. Classes involve lecture and group discussions as well as review of low intensity exercises. The adapted content is presented in large print with high contrast and has been rewritten on a lower grade level. A nutritionist, a physical therapist, a physician, 5 older adults with low vision, 10 low vision occupational therapist, and 5 health literacy experts provided feedback to strengthen the adapted intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 60 and older;\n* Visual impairment with some remaining reading ability.\n\nExclusion Criteria:\n\n* Less than age 60;\n* Complete blindness;\n* Vertebral osteoporosis.'}, 'identificationModule': {'nctId': 'NCT03028493', 'briefTitle': 'Increasing the Accessibility of a Falls Prevention Intervention for Community Dwelling Older Adults With Low Vision', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Increasing the Accessibility of a Falls Prevention Intervention for Community Dwelling Older Adults With Low Vision', 'orgStudyIdInfo': {'id': '01633'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adapted SAFE Intervention', 'description': 'Adapted version of the SAFE Health Behavior and Exercise intervention.', 'interventionNames': ['Behavioral: Adapted SAFE Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Original SAFE Intervention', 'description': 'Original version of the SAFE intervention.', 'interventionNames': ['Behavioral: Original SAFE Intervention']}], 'interventions': [{'name': 'Original SAFE Intervention', 'type': 'BEHAVIORAL', 'description': 'A CDC recommended, evidence-based falls prevention intervention.', 'armGroupLabels': ['Original SAFE Intervention']}, {'name': 'Adapted SAFE Intervention', 'type': 'BEHAVIORAL', 'description': 'An adapted version of the SAFE intervention meant to target older adults with low vision.', 'armGroupLabels': ['Adapted SAFE Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Department of Veteran Affairs', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Cynthia Brown, MD, MSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Birmingham VA and UAB School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All data serves to fulfill dissertation requirement and will not be shared with additional researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sarah Blaylock', 'class': 'OTHER'}, 'collaborators': [{'name': 'VA Office of Research and Development', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Doctoral Candidate Department of Occupational Therapy', 'investigatorFullName': 'Sarah Blaylock', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}