Aging Clinical Trial
Official title:
Potential Fall Risk Increasing Drugs and Falls in Community-dwelling Older Adults: A Prospective Cohort Study
NCT number | NCT05169476 |
Other study ID # | 20155750 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 14, 2018 |
Est. completion date | July 18, 2020 |
Verified date | December 2021 |
Source | Aalborg University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The European Geriatric Medicine Society (EuGMS) Task and Finish Group published a consensus paper on fall-risk increasing drugs. However, the group did not reach consensus on 17 medication classes as potential FRIDs. Thus, in this study the investigators want to examine the association between use of these potential FRIDs and falls rate with a 1-year follow-up in a cohort of community-dwelling older adults, aged 75 years or more.
Status | Completed |
Enrollment | 241 |
Est. completion date | July 18, 2020 |
Est. primary completion date | July 18, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 75 Years and older |
Eligibility | Inclusion criteria: - Community-dwelling older adults - 75 years old or above Exclusion criteria: - Presence of acute illness defined by the presence of a participant-reported experience of illness arisen within 7 days prior to inclusion impairing their everyday functioning in such a way that they opt out of social activities outside their homes while this state is present. - Unable to understand Danish evaluated by the data collectors. - Diagnosed with dementia. - Unable to stand up for 60 seconds without support and visually fixate on an object at the same time. Support is defined by any assistive devices or help from another person. |
Country | Name | City | State |
---|---|---|---|
Denmark | Aktivitetscenter Lynggården | Hirtshals | |
Denmark | Aktivitetscenter Vesterlund | Hjørring | |
Denmark | Forsamlingsbygningen | Hjørring | |
Denmark | Sundhedscenter Hjørring | Hjørring | |
Denmark | Sindal aktivitetscenter | Sindal |
Lead Sponsor | Collaborator |
---|---|
Aalborg University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of falls | Falls will be monitored using monthly prepaid fall calendars and validated by a phone call if a fall is registered. Also, circumstances of the fall will be asked about in the phone call.
Blinding: Assessors of the outcome will be naturally blinded towards the predictors due to test results not being available before end of follow-up. Also, assessors of the outcome will be blinded to the questionnaire results by not having access to these in REDCap |
1-year follow-up |
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