Falls Clinical Trial
NCT number | NCT02835248 |
Other study ID # | 15-0930-01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | May 2018 |
Verified date | July 2018 |
Source | BioSensics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Medical alert devices with automatic fall detection functionality use accelerometry to detect a fall and can signal for help if the wearer forgets to, or is incapable of, pressing the alert button. This can save lives and prevent complications associated with long periods of time spent on the floor after a fall. In this project, the sensitivity and false alarm rate of a commercially available medical alert device will be tested in a population of 200 community-dwelling older adults.
Status | Completed |
Enrollment | 200 |
Est. completion date | May 2018 |
Est. primary completion date | May 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 75 Years and older |
Eligibility |
Inclusion Criteria: - Enrolled in the STRIDE Study at the Boston trial site (http://www.stride-study.org/). Exclusion Criteria: - Uses a medical alert device |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
BioSensics | Brigham and Women's Hospital, Spaulding Rehabilitation Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The sensitivity and specificity of ActivePERS fall detection algorithms will be measured by comparing the occurence of falls detected by the wearable device to study participant self reported falls | 2 years | ||
Secondary | Near falls as measured by patient self report | 2 years |
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