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Clinical Trials/NCT05016141
NCT05016141
Completed
Not Applicable

Health in Motion- A Digital Fall Prevention Program Designed to be Delivered in the Home

Blue Marble Rehab Inc1 site in 1 country101 target enrollmentSeptember 10, 2021
ConditionsAging

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aging
Sponsor
Blue Marble Rehab Inc
Enrollment
101
Locations
1
Primary Endpoint
Rate of Falls per month
Status
Completed
Last Updated
last year

Overview

Brief Summary

Falls among older adults are a serious public health concern and injuries resulting from falls can cause significant loss of independence, premature death, and higher caregiver burden. Home-based fall prevention programs, such as the Otago Exercise Program, educate older adults about the importance of identifying fall risk and provide strategies for reducing fall risk; however, many are costly and are not scalable, accessible, or sustainable. This project will evaluate the use of a digital solution that translates evidence-based fall prevention programs (such as Otago Exercise Program and Matter of Balance) to a digital solution (Health in Motion Fall Prevention Platform), as an alternative to home-based fall prevention programs that is affordable, scales to the millions of older adults across the country at risk for falls and is sustainable for the older adult's life.

Detailed Description

This study will involve 2 groups. Both groups will be followed for 12 months. The investigators will use a comparative prospective longitudinal (12-months) observational cohort study to compare the Health in Motion Fall Prevention Program with a no-intervention group. Metrics of effectiveness include the rate of falls, fall risk, fear of falling, and falls efficacy. Economic benefit will be measured using the EQ-5D-5L, along with hospital and clinical visits. The primary outcome is the incidence of falls (rate in person-months).

Registry
clinicaltrials.gov
Start Date
September 10, 2021
End Date
February 12, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • age of 55 and older
  • if history of 2 or more falls in the past year with a physician or physical therapist approval
  • Score \>31 on the TICS (Telephone Interview for Cognitive Screen)
  • Easy for Me screen for inclusion

Exclusion Criteria

  • any person who has been told by their physician that they should not exercise

Outcomes

Primary Outcomes

Rate of Falls per month

Time Frame: Change from baseline fall rate at 12 months

Number of falls per month / number of participants x 1000

Secondary Outcomes

  • Adherence to Education Modules(through study completion, an average of 1 year)
  • Activities Specific Balance Confidence Scale 5 Level(Change from baseline at 12 months)
  • Depression Screen(Change from baseline at 12 months)
  • Timed Up and Go Test(Change from baseline at 12 months)
  • 30 Second Sit to Stand Test(Change from baseline at 12 months)
  • One Leg Stand Test(Change from baseline at 12 months)
  • VR-12(Change from baseline at 12 months)
  • Education Modules Data (Intervention Group Only)(through study completion, an average of 1 year.)
  • Total number of repetitions of all exercises completed(through study completion, an average of 1 year)
  • 4 Stage Balance Test(Change from baseline at 12 months)
  • European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)(Change from baseline at 12 months)
  • Trail Making Test - Digital(Change from baseline at 12 months)
  • Modified Fear of Falling Avoidance Behavior Questionnaire(Change from baseline at 12 months)
  • Fall Risk Questionnaire(Change from baseline at 12 months)
  • System Usability Scale(Change from baseline at 12 months)
  • Adherence to Exercise Program (Intervention Group Only)(through study completion, an average of 1 year)

Study Sites (1)

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