Clinical trial NCT05016141: Health in Motion- A Pragmatic Clinical Trial- Home
Official title: Health in Motion- A Digital Fall Prevention Program Designed to be Delivered in the Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: fall
fall prevention
fall injury
fear of falling
fall efficacy
Lead sponsor: Blue Marble Rehab Inc
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-08-23
Enrollment: 101
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparative prospective longitudinal (12-months) observational cohort study
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: Rate of Falls per month
timeFrame: Change from baseline fall rate at 3 months
measure: Rate of Falls per month
timeFrame: Change from baseline fall rate at 6 months
measure: Rate of Falls per month
timeFrame: Change from baseline fall rate at 9 months
measure: Rate of Falls per month
timeFrame: Change from baseline fall rate at 12 months
Secondary outcomes:
measure: Timed Up and Go Test
timeFrame: Change from baseline at 3 months
measure: Timed Up and Go Test
timeFrame: Change from baseline at 6 months
measure: Timed Up and Go Test
timeFrame: Change from baseline at 9 months
measure: Timed Up and Go Test
timeFrame: Change from baseline at 12 months
measure: 4 Stage Balance Test
timeFrame: Change from baseline at 3 months
measure: 4 Stage Balance Test
timeFrame: Change from baseline at 6 months
measure: 4 Stage Balance Test
timeFrame: Change from baseline at 9 months
measure: 4 Stage Balance Test
timeFrame: Change from baseline at 12 months
measure: One Leg Stand Test
timeFrame: Change from baseline at 3 months
measure: One Leg Stand Test
timeFrame: Change from baseline at 6 months
measure: One Leg Stand Test
timeFrame: Change from baseline at 9 months
measure: One Leg Stand Test
timeFrame: Change from baseline at 12 months
measure: 30 Second Sit to Stand Test
timeFrame: Change from baseline at 3 months
measure: 30 Second Sit to Stand Test
timeFrame: Change from baseline at 6 months
measure: 30 Second Sit to Stand Test
timeFrame: Change from baseline at 9 months
measure: 30 Second Sit to Stand Test
timeFrame: Change from baseline at 12 months
measure: Fall Risk Questionnaire
timeFrame: Change from baseline at 3 months
measure: Fall Risk Questionnaire
timeFrame: Change from baseline at 6 months
measure: Fall Risk Questionnaire
timeFrame: Change from baseline at 9 months
measure: Fall Risk Questionnaire
timeFrame: Change from baseline at 12 months
measure: Activities Specific Balance Confidence Scale 5 Level
timeFrame: Change from baseline at 3 months
measure: Activities Specific Balance Confidence Scale 5 Level
timeFrame: Change from baseline at 6 months
measure: Activities Specific Balance Confidence Scale 5 Level
timeFrame: Change from baseline at 9 months
measure: Activities Specific Balance Confidence Scale 5 Level
timeFrame: Change from baseline at 12 months
measure: VR-12
timeFrame: Change from baseline at 3 months
measure: VR-12
timeFrame: Change from baseline at 6 months
measure: VR-12
timeFrame: Change from baseline at 9 months
measure: VR-12
timeFrame: Change from baseline at 12 months
measure: European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)
timeFrame: Change from baseline at 3 months
measure: European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)
timeFrame: Change from baseline at 6 months
measure: European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)
timeFrame: Change from baseline at 9 months
measure: European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)
timeFrame: Change from baseline at 12 months
measure: Education Modules Data (Intervention Group Only)
timeFrame: through study completion, an average of 1 year.
measure: Education Modules Data (Intervention Group Only)
timeFrame: through study completion, an average of 1 year.
measure: System Usability Scale
timeFrame: Change from baseline at 3 months
measure: System Usability Scale
timeFrame: Change from baseline at 6 months
measure: System Usability Scale
timeFrame: Change from baseline at 9 months
measure: System Usability Scale
timeFrame: Change from baseline at 12 months
measure: Trail Making Test - Digital
timeFrame: Change from baseline at 3 months
measure: Trail Making Test - Digital
timeFrame: Change from baseline at 6 months
measure: Trail Making Test - Digital
timeFrame: Change from baseline at 9 months
measure: Trail Making Test - Digital
timeFrame: Change from baseline at 12 months
measure: Modified Fear of Falling Avoidance Behavior Questionnaire
timeFrame: Change from baseline at 3 months
measure: Modified Fear of Falling Avoidance Behavior Questionnaire
timeFrame: Change from baseline at 6 months
measure: Modified Fear of Falling Avoidance Behavior Questionnaire
timeFrame: Change from baseline at 9 months
measure: Modified Fear of Falling Avoidance Behavior Questionnaire
timeFrame: Change from baseline at 12 months
measure: Depression Screen
timeFrame: Change from baseline at 3 months
measure: Depression Screen
timeFrame: Change from baseline at 6 months
measure: Depression Screen
timeFrame: Change from baseline at 9 months
measure: Depression Screen
timeFrame: Change from baseline at 12 months
measure: Adherence to Exercise Program (Intervention Group Only)
timeFrame: through study completion, an average of 1 year
measure: Total number of repetitions of all exercises completed
timeFrame: through study completion, an average of 1 year
measure: Adherence to Education Modules
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Altadena
country: United States
facility: Blue Marble Health
state: California
Study officials:
affiliation: Texas A&M University
name: Matthew Smith, PhD
role: STUDY_DIRECTOR
References: