Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-22 @ 5:38 AM
Study NCT ID:
NCT02775604
Status:
COMPLETED
Last Update Posted:
2024-05-10
First Post:
2016-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Home-based Video, Paper/Print Checklist and Professional Home Assessment in Detection of Fall Hazards at Home
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-09', 'studyFirstSubmitDate': '2016-05-12', 'studyFirstSubmitQcDate': '2016-05-13', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation Agreement', 'timeFrame': 'Within 1 week of completion of assessment', 'description': 'Fall hazard scores will be calculated based on the number and severity of hazards identified from the paper checklist, the GoPro assessment, and the independent evaluation. The extent of agreement on fall-hazard score and time taken to complete the evaluations (home-based video, paper/print checklist; professional home assessment) will be assessed.'}], 'secondaryOutcomes': [{'measure': 'Feasibility and Fidelity', 'timeFrame': 'Within 1 week of completion of assessment', 'description': 'Semi-structured phone interviews will be conducted to collect participant feedback on the feasibility, usability, usefulness, acceptance, barriers, facilitators, respondent burden and preference for using GoPro video-technology vs. pp-CHFHC vs. professional assessment. During the interview, participants will also be asked about their prior awareness of fall hazards and experiences about the different methods of detecting fall hazards in their home.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fall risks at home', 'video technology', 'home assessment', 'distal radius fractures'], 'conditions': ['Identification of Home Fall Hazards']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the feasibility and potential impact of video analysis of footage taken with a GoPro camera video in comparison to a homeowner checklist or gold standard home assessment as a means of detecting home fall hazards.\n\nInvestigators hypothesize that the assessment of homes for fall hazards with a GoPro camera will be better than a homeowner paper checklist in hazard identification.', 'detailedDescription': '80 community-dwelling adults (50-75 years of age) will be recruited from clinics and the community through posters and advertising (n = 40 in the Healthy Group; n = 40 in the Distal Radius Fracture (DRF) Group (adults with 3-12 months post-DRF)).\n\nParticipants will be randomly allocated to a homeowner paper checklist or a GoPro video assessment and then cross-over to the opposite intervention.\n\nTo assess accuracy, a gold standard home assessment will be completed by a trained evaluator, after the homeowner checklist and GoPro video assessment.\n\nUpon completion of the data collection, the evaluator will conduct their assessment (gold standard); review the findings from the GoPro "playback" with the participant, and conduct a semi-structured interview on their prior awareness of fall hazards, perceptions about the different methods of detecting fall hazards in their home; and intentions to remediate identified hazards.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Group: community-dwelling adults\n* DRF Group: adults with 3-12 months post DRF\n* ability to read, understand and speak English\n\nExclusion Criteria:\n\n* identified cognitive disorder\n* major loss of vision or hearing\n* other concurrent upper extremity injuries or neurological impairments\n* any unhealed fractures'}, 'identificationModule': {'nctId': 'NCT02775604', 'briefTitle': 'Comparison of Home-based Video, Paper/Print Checklist and Professional Home Assessment in Detection of Fall Hazards at Home', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Comparison of Home-based Video, Paper/Print Checklist and Professional Home Assessment in the Detection of Fall Hazards for Older Adults Living at Home: A Pilot Randomized Crossover Trial', 'orgStudyIdInfo': {'id': 'HIREB 1950'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Home-Based Video', 'description': 'GoPro Camera', 'interventionNames': ["Behavioral: Video based/Therapists' rating of comprehensive-home-fall-hazard-checklist (vt-CHFHC)"]}, {'type': 'OTHER', 'label': 'Paper Checklist', 'description': 'Homeowner Print Checklist', 'interventionNames': ['Behavioral: Paper based/Patient self-rating of comprehensive-home-fall-hazard-checklist (pp-CHFHC)']}], 'interventions': [{'name': "Video based/Therapists' rating of comprehensive-home-fall-hazard-checklist (vt-CHFHC)", 'type': 'BEHAVIORAL', 'description': 'The participant will use GoPro technology and follow standardized instructions to inspect each room of their house. They will navigate through their home wearing the GoPro camera, recording images about their home and their usual activities and use a talk-aloud approach to describe what they are doing and seeing. The evaluator will provide no feedback during the assessments.', 'armGroupLabels': ['Home-Based Video']}, {'name': 'Paper based/Patient self-rating of comprehensive-home-fall-hazard-checklist (pp-CHFHC)', 'type': 'BEHAVIORAL', 'description': 'A paper version of CHFHC and other self-reported documents will be completed by the participants in their homes based on standardized verbal instruction provided by the research staff.', 'armGroupLabels': ['Paper Checklist']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8S 1C7', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}