Health in Motion- A Pragmatic Clinical Trial- Home

NCT05016141 | Completed

• 2 other identifiers: AG0431912R44AG043191-04A1
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

fall; fall prevention; fall injury; fear of falling; fall efficacy

Outcome Measures

Primary Outcomes (4)

• Rate of Falls per month

  Number of falls per month / number of participants x 1000

  Change from baseline fall rate at 3 months

• Rate of Falls per month

  Number of falls per month / number of participants x 1000

  Change from baseline fall rate at 6 months

• Rate of Falls per month

  Number of falls per month / number of participants x 1000

  Change from baseline fall rate at 9 months

• Rate of Falls per month

  Number of falls per month / number of participants x 1000

  Change from baseline fall rate at 12 months

Secondary Outcomes (53)

• Timed Up and Go Test

  Change from baseline at 3 months

• Timed Up and Go Test

  Change from baseline at 6 months

• Timed Up and Go Test

  Change from baseline at 9 months

• Timed Up and Go Test

  Change from baseline at 12 months

• 4 Stage Balance Test

  Change from baseline at 3 months

Study Arms (2)

no intervention

NO INTERVENTION

Participants will be observed for 12 months. Participants will use the Health in Motion app to set goals and keep track of their health and health events, including falls. These participants will NOT receive the education modules or the exercise program.

digital fall prevention program

EXPERIMENTAL

Participants will complete the Health in Motion digital fall prevention program for 12 months. This program consists of education modules (modified from the Matter of Balance Program) and exercises based on a digital translation of the Otago Exercise Program.

Behavioral: digital fall prevention program

Interventions

digital fall prevention program BEHAVIORAL

The participants will receive a digital fall prevention program consisting of fall risk reduction education (modified Matter of Balance), Otago Exercise Program, Personalized S.M.A.R.T Goals, and will use the app to keep track of their health and health events, including falls.

digital fall prevention program

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Blue Marble Rehab Inc: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Blue Marble Health

Altadena, California, 91001, United States

Location

Study Officials

• Matthew Smith, PhD

  Texas A&M University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: comparative prospective longitudinal (12-months) observational cohort study

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 23, 2021
• Study Start: September 10, 2021
• Primary Completion: October 23, 2023
• Study Completion: February 12, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)