Health in Motion- A Pragmatic Clinical Trial- Home

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

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Behavioral: digital fall prevention program

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).

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Altadena, California, United States, 91001
      • Blue Marble Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed Up and Go Test	Time taken to stand up from a seated position, walk 10 feet, turn around, return to the chair, sit down	Change from baseline at 3 months
Timed Up and Go Test	Time taken to stand up from a seated position, walk 10 feet, turn around, return to the chair, sit down	Change from baseline at 6 months
Timed Up and Go Test	Time taken to stand up from a seated position, walk 10 feet, turn around, return to the chair, sit down	Change from baseline at 9 months
Timed Up and Go Test	Time taken to stand up from a seated position, walk 10 feet, turn around, return to the chair, sit down	Change from baseline at 12 months
4 Stage Balance Test	This test measures the ability to stand for 10 seconds in 4 progressively more challenging positions from standing with feet side by side to standing on one leg. The score is equal to the total time taken to achieve the highest level. The maximum score is 40. If a participant is not able to stand with their feet in tandem, they are considered at higher risk of falling.	Change from baseline at 3 months
4 Stage Balance Test	This test measures the ability to stand for 10 seconds in 4 progressively more challenging positions from standing with feet side by side to standing on one leg. The score is equal to the total time taken to achieve the highest level. The maximum score is 40. If a participant is not able to stand with their feet in tandem, they are considered at higher risk of falling.	Change from baseline at 6 months
4 Stage Balance Test	This test measures the ability to stand for 10 seconds in 4 progressively more challenging positions from standing with feet side by side to standing on one leg. The score is equal to the total time taken to achieve the highest level. The maximum score is 40. If a participant is not able to stand with their feet in tandem, they are considered at higher risk of falling.	Change from baseline at 9 months
4 Stage Balance Test	This test measures the ability to stand for 10 seconds in 4 progressively more challenging positions from standing with feet side by side to standing on one leg. The score is equal to the total time taken to achieve the highest level. The maximum score is 40. If a participant is not able to stand with their feet in tandem, they are considered at higher risk of falling.	Change from baseline at 12 months
One Leg Stand Test	This test measures the ability to stand for on one leg for up to 30 seconds. If a participant is not able to stand for 5 seconds, they are considered at higher risk of falling.	Change from baseline at 3 months
One Leg Stand Test	This test measures the ability to stand for on one leg for up to 30 seconds. If a participant is not able to stand for 5 seconds, they are considered at higher risk of falling.	Change from baseline at 6 months
One Leg Stand Test	This test measures the ability to stand for on one leg for up to 30 seconds. If a participant is not able to stand for 5 seconds, they are considered at higher risk of falling.	Change from baseline at 9 months
One Leg Stand Test	This test measures the ability to stand for on one leg for up to 30 seconds. If a participant is not able to stand for 5 seconds, they are considered at higher risk of falling.	Change from baseline at 12 months
30 Second Sit to Stand Test	This test measures the number of times a participant can stand up from a seated position in 30 seconds.	Change from baseline at 3 months
30 Second Sit to Stand Test	This test measures the number of times a participant can stand up from a seated position in 30 seconds.	Change from baseline at 6 months
30 Second Sit to Stand Test	This test measures the number of times a participant can stand up from a seated position in 30 seconds.	Change from baseline at 9 months
30 Second Sit to Stand Test	This test measures the number of times a participant can stand up from a seated position in 30 seconds.	Change from baseline at 12 months
Fall Risk Questionnaire	This is a multi-factorial questionnaire that can be used to predict fall risk. Questions relate to history of falls, gait/balance, muscle weakness, incontinence, sensation/proprioception, depression, vision and medications. The highest (worst) score = 14. A score of 0-3 denotes low fall risk and scores from 4-14 denote higher fall risk.	Change from baseline at 3 months
Fall Risk Questionnaire	This is a multi-factorial questionnaire that can be used to predict fall risk. Questions relate to history of falls, gait/balance, muscle weakness, incontinence, sensation/proprioception, depression, vision and medications. The highest (worst) score = 14. A score of 0-3 denotes low fall risk and scores from 4-14 denote higher fall risk.	Change from baseline at 6 months
Fall Risk Questionnaire	This is a multi-factorial questionnaire that can be used to predict fall risk. Questions relate to history of falls, gait/balance, muscle weakness, incontinence, sensation/proprioception, depression, vision and medications. The highest (worst) score = 14. A score of 0-3 denotes low fall risk and scores from 4-14 denote higher fall risk.	Change from baseline at 9 months
Fall Risk Questionnaire	This is a multi-factorial questionnaire that can be used to predict fall risk. Questions relate to history of falls, gait/balance, muscle weakness, incontinence, sensation/proprioception, depression, vision and medications. The highest (worst) score = 14. A score of 0-3 denotes low fall risk and scores from 4-14 denote higher fall risk.	Change from baseline at 12 months
Activities Specific Balance Confidence Scale 5 Level	This questionnaire measures the participant's confidence in performing activities of daily living in which each item is rated from 0% (no confidence) to 100% (complete confidence). It correlates with other measures of self-efficacy and balance measures.	Change from baseline at 3 months
Activities Specific Balance Confidence Scale 5 Level	This questionnaire measures the participant's confidence in performing activities of daily living in which each item is rated from 0% (no confidence) to 100% (complete confidence). It correlates with other measures of self-efficacy and balance measures.	Change from baseline at 6 months
Activities Specific Balance Confidence Scale 5 Level	This questionnaire measures the participant's confidence in performing activities of daily living in which each item is rated from 0% (no confidence) to 100% (complete confidence). It correlates with other measures of self-efficacy and balance measures.	Change from baseline at 9 months
Activities Specific Balance Confidence Scale 5 Level	This questionnaire measures the participant's confidence in performing activities of daily living in which each item is rated from 0% (no confidence) to 100% (complete confidence). It correlates with other measures of self-efficacy and balance measures.	Change from baseline at 12 months
VR-12	This questionnaire measures quality of life over the past 4 weeks.	Change from baseline at 3 months
VR-12	This questionnaire measures quality of life over the past 4 weeks.	Change from baseline at 6 months
VR-12	This questionnaire measures quality of life over the past 4 weeks.	Change from baseline at 9 months
VR-12	This questionnaire measures quality of life over the past 4 weeks.	Change from baseline at 12 months
European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)	This is a standardized measure of health status for clinical and economic appraisal. The test is a self report health state that domains including mobility, self-care, anxiety/depression, pain/discomfort) using a 5 point scale and a visual analog scale (VAS). We will calculate quality-adjusted life years (QALY) using the EQ-5D-5L and the appropriate weights from each instrument to compare differences in the incremental cost-effectiveness ratios.	Change from baseline at 3 months
European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)	This is a standardized measure of health status for clinical and economic appraisal. The test is a self report health state that domains including mobility, self-care, anxiety/depression, pain/discomfort) using a 5 point scale and a visual analog scale (VAS). We will calculate quality-adjusted life years (QALY) using the EQ-5D-5L and the appropriate weights from each instrument to compare differences in the incremental cost-effectiveness ratios.	Change from baseline at 6 months
European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)	This is a standardized measure of health status for clinical and economic appraisal. The test is a self report health state that domains including mobility, self-care, anxiety/depression, pain/discomfort) using a 5 point scale and a visual analog scale (VAS). We will calculate quality-adjusted life years (QALY) using the EQ-5D-5L and the appropriate weights from each instrument to compare differences in the incremental cost-effectiveness ratios.	Change from baseline at 9 months
European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)	This is a standardized measure of health status for clinical and economic appraisal. The test is a self report health state that domains including mobility, self-care, anxiety/depression, pain/discomfort) using a 5 point scale and a visual analog scale (VAS). We will calculate quality-adjusted life years (QALY) using the EQ-5D-5L and the appropriate weights from each instrument to compare differences in the incremental cost-effectiveness ratios.	Change from baseline at 12 months
Education Modules Data (Intervention Group Only)	Time Taken: The Health in Motion App captures data time taken to complete the lessons.	through study completion, an average of 1 year.
Education Modules Data (Intervention Group Only)	Qualitative Analysis of text entries.	through study completion, an average of 1 year.
System Usability Scale	The System Usability Scale is used to evaluate usability and learnability of software products. We will use information from this survey to improve the usability of Health in Motion. The test uses a 0-5 Likert scale. The statements are worded such that the best score alternates between 1 (Strongly Disagree) and 5 (Strongly Agree). For example, statement #1 is "I think that I would like to use this system frequently" whereas statement #2 is "I found this system unnecessarily complex". The participant's scores for each question are converted to a new number, added together, and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. SUS scores above 68 are considered above average and anything below 68 is below average.	Change from baseline at 3 months
System Usability Scale	The System Usability Scale is used to evaluate usability and learnability of software products. We will use information from this survey to improve the usability of Health in Motion. The test uses a 0-5 Likert scale. The statements are worded such that the best score alternates between 1 (Strongly Disagree) and 5 (Strongly Agree). For example, statement #1 is "I think that I would like to use this system frequently" whereas statement #2 is "I found this system unnecessarily complex". The participant's scores for each question are converted to a new number, added together, and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. SUS scores above 68 are considered above average and anything below 68 is below average.	Change from baseline at 6 months
System Usability Scale	The System Usability Scale is used to evaluate usability and learnability of software products. We will use information from this survey to improve the usability of Health in Motion. The test uses a 0-5 Likert scale. The statements are worded such that the best score alternates between 1 (Strongly Disagree) and 5 (Strongly Agree). For example, statement #1 is "I think that I would like to use this system frequently" whereas statement #2 is "I found this system unnecessarily complex". The participant's scores for each question are converted to a new number, added together, and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. SUS scores above 68 are considered above average and anything below 68 is below average.	Change from baseline at 9 months
System Usability Scale	The System Usability Scale is used to evaluate usability and learnability of software products. We will use information from this survey to improve the usability of Health in Motion. The test uses a 0-5 Likert scale. The statements are worded such that the best score alternates between 1 (Strongly Disagree) and 5 (Strongly Agree). For example, statement #1 is "I think that I would like to use this system frequently" whereas statement #2 is "I found this system unnecessarily complex". The participant's scores for each question are converted to a new number, added together, and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. SUS scores above 68 are considered above average and anything below 68 is below average.	Change from baseline at 12 months
Trail Making Test - Digital	This is a standardized test of cognitive function. The test consists of two Trails, Trail A and Trail B. Trail A requires the participant to tap on 25 numbers on the screen in order from smallest to largest (1, 2, 3, etc). Trail B requires participants to tap on alternative numbers and letters in consecutive order from smallest/first to largest/last (1, A, 2, B, 3, C etc).	Change from baseline at 3 months
Trail Making Test - Digital	This is a standardized test of cognitive function. The test consists of two Trails, Trail A and Trail B. Trail A requires the participant to tap on 25 numbers on the screen in order from smallest to largest (1, 2, 3, etc). Trail B requires participants to tap on alternative numbers and letters in consecutive order from smallest/first to largest/last (1, A, 2, B, 3, C etc).	Change from baseline at 6 months
Trail Making Test - Digital	This is a standardized test of cognitive function. The test consists of two Trails, Trail A and Trail B. Trail A requires the participant to tap on 25 numbers on the screen in order from smallest to largest (1, 2, 3, etc). Trail B requires participants to tap on alternative numbers and letters in consecutive order from smallest/first to largest/last (1, A, 2, B, 3, C etc).	Change from baseline at 9 months
Trail Making Test - Digital	This is a standardized test of cognitive function. The test consists of two Trails, Trail A and Trail B. Trail A requires the participant to tap on 25 numbers on the screen in order from smallest to largest (1, 2, 3, etc). Trail B requires participants to tap on alternative numbers and letters in consecutive order from smallest/first to largest/last (1, A, 2, B, 3, C etc).	Change from baseline at 12 months
Modified Fear of Falling Avoidance Behavior Questionnaire	This is a standardized self-report assessment that measures behaviors that may be avoided due to a fear of falling	Change from baseline at 3 months
Modified Fear of Falling Avoidance Behavior Questionnaire	This is a standardized self-report assessment that measures behaviors that may be avoided due to a fear of falling	Change from baseline at 6 months
Modified Fear of Falling Avoidance Behavior Questionnaire	This is a standardized self-report assessment that measures behaviors that may be avoided due to a fear of falling	Change from baseline at 9 months
Modified Fear of Falling Avoidance Behavior Questionnaire	This is a standardized self-report assessment that measures behaviors that may be avoided due to a fear of falling	Change from baseline at 12 months
Depression Screen	The Depression Screen is a 2-item questionnaire that asks about how the person has been feeling over the past 2 weeks.	Change from baseline at 3 months
Depression Screen	The Depression Screen is a 2-item questionnaire that asks about how the person has been feeling over the past 2 weeks.	Change from baseline at 6 months
Depression Screen	The Depression Screen is a 2-item questionnaire that asks about how the person has been feeling over the past 2 weeks.	Change from baseline at 9 months
Depression Screen	The Depression Screen is a 2-item questionnaire that asks about how the person has been feeling over the past 2 weeks.	Change from baseline at 12 months
Adherence to Exercise Program (Intervention Group Only)	Average number of days per week the exercise program was completed	through study completion, an average of 1 year
Total number of repetitions of all exercises completed	Total number of repetitions of all exercises completed	through study completion, an average of 1 year
Adherence to Education Modules	Total number of education modules completed	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Blue Marble Rehab Inc
• Collaborators: National Institute on Aging (NIA)
• Investigators: Study Director: Matthew Smith, PhD, Texas A&M University

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Actual): October 23, 2023
• Study Completion (Actual): February 12, 2024

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 29, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: fall prevention; fear of falling; fall; fall efficacy; fall injury
• Other Study ID Numbers: AG043191; 2R44AG043191-04A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No