Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-29 @ 12:21 AM
Study NCT ID:
NCT01022866
Status:
UNKNOWN
Last Update Posted:
2020-09-11
First Post:
2009-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Falls Prevention Clinic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 440}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-09', 'studyFirstSubmitDate': '2009-11-27', 'studyFirstSubmitQcDate': '2009-11-27', 'lastUpdatePostDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['falls', 'older adults'], 'conditions': ['Falls']}, 'referencesModule': {'references': [{'pmid': '26449355', 'type': 'DERIVED', 'citation': 'Davis JC, Dian L, Khan KM, Bryan S, Marra CA, Hsu CL, Jacova P, Chiu BK, Liu-Ambrose T. Cognitive status is a determinant of health resource utilization among individuals with a history of falls: a 12-month prospective cohort study. Osteoporos Int. 2016 Mar;27(3):943-951. doi: 10.1007/s00198-015-3350-4. Epub 2015 Oct 8.'}, {'pmid': '25862255', 'type': 'DERIVED', 'citation': 'Davis JC, Best JR, Bryan S, Li LC, Hsu CL, Gomez C, Vertes K, Liu-Ambrose T. Mobility Is a Key Predictor of Change in Well-Being Among Older Adults Who Experience Falls: Evidence From the Vancouver Falls Prevention Clinic Cohort. Arch Phys Med Rehabil. 2015 Sep;96(9):1634-40. doi: 10.1016/j.apmr.2015.02.033. Epub 2015 Apr 8.'}, {'pmid': '23095570', 'type': 'DERIVED', 'citation': 'Davis JC, Bryan S, McLeod R, Rogers J, Khan K, Liu-Ambrose T. Exploration of the association between quality of life, assessed by the EQ-5D and ICECAP-O, and falls risk, cognitive function and daily function, in older adults with mobility impairments. BMC Geriatr. 2012 Oct 24;12:65. doi: 10.1186/1471-2318-12-65.'}]}, 'descriptionModule': {'briefSummary': 'At the Falls Prevention Clinic, each subject receives a comprehensive assessment of his or her individual risk factors for falling in addition to a comprehensive medical examination. Recommendations and appropriate followup tests and referrals are ordered for patients on an individual basis.\n\nEssential for medical advancement is the inquiry into information collected from medical records of older adults at high risk of falls and fracture. On such example is a retrospective chart review we conducted among patients who sustained a hip fracture \\[14\\]. The database we propose will provide novel insight into the identification of individuals at high risk for falls, key predictors of falls and associated mortality, morbidity, health related quality of life and healthcare resource utilization. In summary, our database will enable us to assess and improve quality of care, service delivery, patient outcomes, patient reported outcomes and track economic burden.', 'detailedDescription': "Purpose: In community-dwelling seniors aged 70 years and older who attend the Vancouver Falls Prevention Clinic and who consent to allowing their data to form part of the Falls Prevention Clinic Database, we will audit charts to answer the following questions: 1) In terms of mobility and functional status, what characterizes the patient population that is referred to the Falls Prevention Clinic? 2) What is the physiological profile assessment (PPA) of individuals at the Falls Prevention Clinic? 3) What are the demographic characteristics? 4) What are factors that explain differences in health related quality of life and healthcare resource utilization? and 5) For individuals who have a high falls risk profile, what are their specific clinical outcome measures that indicate better or worse health related quality of life?\n\nObjective: To develop a Falls Prevention Clinic Database for subjects who attend the Falls Prevention Clinic at Vancouver General Hospital and Lion's Gate Hospital."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Falls Prevention Clinic', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults ≥70 years attending a Falls Prevention Clinic Service;\n* Understands, speaks, and reads English proficiently;\n* MMSE \\[11\\] score \\> 24/30;\n* A Physiological Profile Assessment (PPA) © \\[15\\] score of at least 2 SD above normal OR Timed Up and Go Test (TUG) 68 performance of greater than 15 seconds OR history of at least 2 falls in the previous 12 months;\n* Expected to live greater than12 months;\n* Living in the Metropolitan Vancouver area;\n* Community-dwelling (i.e., not residing in a nursing home, extended care unit, or assisted-care facility);\n* Able to walk 3 meters with or without an assistive device; and\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Diagnosed with a neurodegenerative disease (e.g., Parkinson's disease);\n* Diagnosed with dementia (of any type);\n* Had a stroke;\n* Have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease; or\n* Have a history indicative of carotid sinus sensitivity (i.e., syncopal falls)."}, 'identificationModule': {'nctId': 'NCT01022866', 'briefTitle': 'Falls Prevention Clinic', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Vancouver Falls Prevention Clinic Database', 'orgStudyIdInfo': {'id': 'H09-02370'}}, 'contactsLocationsModule': {'locations': [{'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Caitlyn Gomez', 'role': 'CONTACT', 'email': 'Gomez.caitlyn@gmail.com', 'phone': '604-875-4111', 'phoneExt': '66459'}], 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Stephanie Doherty, MA', 'role': 'CONTACT', 'email': 'stephanie.doherty@hiphealth.ca', 'phone': '604-875-4111', 'phoneExt': '69313'}], 'overallOfficials': [{'name': 'Jennifer Davis', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of British Columbia'}, {'name': 'Karim Khan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of British Columbia'}, {'name': 'Teresa Liu-Ambrose', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Teresa Liu-Ambrose', 'investigatorAffiliation': 'University of British Columbia'}}}}