Health in Motion- A Pragmatic Clinical Trial- Home

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05016141
• Other study ID #: AG043191
• Secondary ID: 2R44AG043191-04A
• Status: Completed
• Phase: N/A
• Start date: July 17, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: March 2024
• Source: Blue Marble Rehab Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• age of 55 and older

• 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

Related Conditions & MeSH terms

• Aging

Intervention

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.

Locations

Country	Name	City	State
United States	Blue Marble Health	Altadena	California

Sponsors (2)

Lead Sponsor	Collaborator
Blue Marble Rehab Inc	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Falls per month	Number of falls per month / number of participants x 1000	Change from baseline fall rate at 3 months
Primary	Rate of Falls per month	Number of falls per month / number of participants x 1000	Change from baseline fall rate at 6 months
Primary	Rate of Falls per month	Number of falls per month / number of participants x 1000	Change from baseline fall rate at 9 months
Primary	Rate of Falls per month	Number of falls per month / number of participants x 1000	Change from baseline fall rate at 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	VR-12	This questionnaire measures quality of life over the past 4 weeks.	Change from baseline at 3 months
Secondary	VR-12	This questionnaire measures quality of life over the past 4 weeks.	Change from baseline at 6 months
Secondary	VR-12	This questionnaire measures quality of life over the past 4 weeks.	Change from baseline at 9 months
Secondary	VR-12	This questionnaire measures quality of life over the past 4 weeks.	Change from baseline at 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	Education Modules Data (Intervention Group Only)	Qualitative Analysis of text entries.	through study completion, an average of 1 year.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Total number of repetitions of all exercises completed	Total number of repetitions of all exercises completed	through study completion, an average of 1 year
Secondary	Adherence to Education Modules	Total number of education modules completed	through study completion, an average of 1 year