A Novel System to Detect Falls in Real-life Conditions

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.

Study Overview

• Status: Completed
• Conditions: Falls
• Intervention / Treatment: Other: Fall Detection

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02120
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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/).

Description

Inclusion Criteria:

• Enrolled in the STRIDE Study at the Boston trial site (http://www.stride-study.org/).

Exclusion Criteria:

• Uses a medical alert device

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Near falls as measured by patient self report	2 years

Collaborators and Investigators

• Sponsor: BioSensics
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: July 8, 2016
• First Submitted That Met QC Criteria: July 13, 2016
• First Posted (Estimate): July 18, 2016

Study Record Updates

• Last Update Posted (Actual): July 24, 2018
• Last Update Submitted That Met QC Criteria: July 23, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 15-0930-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO