NCT02835248

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 18, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

2.7 years

First QC Date

July 8, 2016

Last Update Submit

July 23, 2018

Conditions

Falls

Outcome Measures

Primary Outcomes (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 Outcomes (1)

  • Near falls as measured by patient self report

    2 years

Study Arms (1)

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

Interventions

Fall DetectionOTHER

All participants will wear a device configured to detect falls.

Also known as: ActivePERS
Primary

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-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/).

You may qualify if:

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

You may not qualify if:

  • Uses a medical alert device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Study Officials

  • Shalendar Bhasin, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

  • Joseph T Gwin, PhD

    BioSensics

    PRINCIPAL INVESTIGATOR

  • Paolo Bonato, PhD

    Spaulding Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2016

First Posted

July 18, 2016

Study Start

September 1, 2015

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

July 24, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)