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A Novel System to Detect Falls in Real-life Conditions

Sponsor
BioSensics (Industry)
Overall Status
Completed
CT.gov ID
NCT02835248
Collaborator
Brigham and Women's Hospital (Other), Spaulding Rehabilitation Hospital (Other)
200
Enrollment
1
Location
32
Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Fall Detection

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
May 1, 2018
Actual Study Completion Date :
May 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Primary

Older adult study participants will be recruited from the cohort of participants in the STRIDE Study at the Boston trial site (http://www.stride-study.org/).

Other: Fall Detection
All participants will wear a device configured to detect falls.
Other Names:
  • ActivePERS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Near falls as measured by patient self report [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    75 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    Exclusion Criteria:
    • Uses a medical alert device

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brigham and Women's Hospital Boston Massachusetts United States 02120

    Sponsors and Collaborators

    • BioSensics
    • Brigham and Women's Hospital
    • Spaulding Rehabilitation Hospital

    Investigators

    • Principal Investigator: Shalendar Bhasin, MD, Brigham and Women's Hospital
    • Principal Investigator: Joseph T Gwin, PhD, BioSensics
    • Principal Investigator: Paolo Bonato, PhD, Spaulding Rehabilitation Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BioSensics
    ClinicalTrials.gov Identifier:
    NCT02835248
    Other Study ID Numbers:
    • 15-0930-01
    First Posted:
    Jul 18, 2016
    Last Update Posted:
    Jul 24, 2018
    Last Verified:
    Jul 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Jul 24, 2018