Health in Motion- A Pragmatic Clinical Trial- Home

NCT ID: NCT05016141

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-10

Study Completion Date

2024-02-12

Brief Summary

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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

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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).

Conditions

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Aging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

comparative prospective longitudinal (12-months) observational cohort study
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

digital fall prevention program

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.

Group Type EXPERIMENTAL

digital fall prevention program

Intervention Type 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.

Interventions

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digital fall prevention program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Blue Marble Rehab Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Smith, PhD

Role: STUDY_DIRECTOR

Texas A&M University

Locations

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Blue Marble Health

Altadena, California, United States

Site Status

Countries

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United States

Other Identifiers

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2R44AG043191-04A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AG043191

Identifier Type: -

Identifier Source: org_study_id

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