AgingNCT05016141
Health in Motion- A Pragmatic Clinical Trial- Home
A study testing digital fall prevention program in people with Aging, run by Blue Marble Rehab Inc at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- digital fall prevention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2021to 12 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- any person who has been told by their physician that they should not exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Aging
- Being tested
- digital fall prevention program
- Keywords
- fall, fall prevention, fall injury, fear of falling, fall efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital fall prevention programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: digital fall prevention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Falls per month
Number of falls per month / number of participants x 1000
Measured: Change from baseline fall rate at 3 months
Rate of Falls per month
Number of falls per month / number of participants x 1000
Measured: Change from baseline fall rate at 6 months
Rate of Falls per month
Number of falls per month / number of participants x 1000
Measured: Change from baseline fall rate at 9 months
Rate of Falls per month
Number of falls per month / number of participants x 1000
Measured: Change from baseline fall rate at 12 months
Secondary outcomes (53)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline at 12 months
VR-12
This questionnaire measures quality of life over the past 4 weeks.
Measured: Change from baseline at 3 months
VR-12
This questionnaire measures quality of life over the past 4 weeks.
Measured: Change from baseline at 6 months
VR-12
This questionnaire measures quality of life over the past 4 weeks.
Measured: Change from baseline at 9 months
VR-12
This questionnaire measures quality of life over the past 4 weeks.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 1 year.
Education Modules Data (Intervention Group Only)
Qualitative Analysis of text entries.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline at 12 months
Adherence to Exercise Program (Intervention Group Only)
Average number of days per week the exercise program was completed
Measured: through study completion, an average of 1 year
Total number of repetitions of all exercises completed
Total number of repetitions of all exercises completed
Measured: through study completion, an average of 1 year
Adherence to Education Modules
Total number of education modules completed
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start10 Sep 2021
- Primary completion23 Oct 2023
- Study completion12 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- comparative prospective longitudinal (12-months) observational cohort study
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blue Marble Rehab Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Matthew Smith, PhD, Study director, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016141
- Sponsor's protocol ID
- AG043191
- Other IDs
- 2R44AG043191-04A1
- Status last verified
- Sep 2024
- First submitted
- 19 Jul 2021
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health in Motion- A Digital Fall Prevention Program Designed to be Delivered in the Home
- ClinicalTrials.gov ID
- NCT05016141
- Acronym / sponsor ID
- AG043191
- Conditions
- Aging
- Keywords
- fall, fall prevention, fall injury, fear of falling, fall efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Blue Marble Rehab IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 12 Feb 2024 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- comparative prospective longitudinal (12-months) observational cohort study
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: digital fall prevention programParticipants 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- any person who has been told by their physician that they should not exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital fall prevention programThe 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. | Behavioural | digital fall prevention program |
Primary outcome
Rate of Falls per month
Time frame: Change from baseline fall rate at 3 months
Number of falls per month / number of participants x 1000
Rate of Falls per month
Time frame: Change from baseline fall rate at 6 months
Number of falls per month / number of participants x 1000
Rate of Falls per month
Time frame: Change from baseline fall rate at 9 months
Number of falls per month / number of participants x 1000
Rate of Falls per month
Time frame: Change from baseline fall rate at 12 months
Number of falls per month / number of participants x 1000
53 secondary outcomes
Timed Up and Go Test
Time frame: Change from baseline at 3 months
Timed Up and Go Test
Time frame: Change from baseline at 6 months
Timed Up and Go Test
Time frame: Change from baseline at 9 months
Timed Up and Go Test
Time frame: Change from baseline at 12 months
4 Stage Balance Test
Time frame: Change from baseline at 3 months
4 Stage Balance Test
Time frame: Change from baseline at 6 months
4 Stage Balance Test
Time frame: Change from baseline at 9 months
4 Stage Balance Test
Time frame: Change from baseline at 12 months
One Leg Stand Test
Time frame: Change from baseline at 3 months
One Leg Stand Test
Time frame: Change from baseline at 6 months
One Leg Stand Test
Time frame: Change from baseline at 9 months
One Leg Stand Test
Time frame: Change from baseline at 12 months
30 Second Sit to Stand Test
Time frame: Change from baseline at 3 months
30 Second Sit to Stand Test
Time frame: Change from baseline at 6 months
30 Second Sit to Stand Test
Time frame: Change from baseline at 9 months
30 Second Sit to Stand Test
Time frame: Change from baseline at 12 months
Fall Risk Questionnaire
Time frame: Change from baseline at 3 months
Fall Risk Questionnaire
Time frame: Change from baseline at 6 months
Fall Risk Questionnaire
Time frame: Change from baseline at 9 months
Fall Risk Questionnaire
Time frame: Change from baseline at 12 months
Activities Specific Balance Confidence Scale 5 Level
Time frame: Change from baseline at 3 months
Activities Specific Balance Confidence Scale 5 Level
Time frame: Change from baseline at 6 months
Activities Specific Balance Confidence Scale 5 Level
Time frame: Change from baseline at 9 months
Activities Specific Balance Confidence Scale 5 Level
Time frame: Change from baseline at 12 months
VR-12
Time frame: Change from baseline at 3 months
VR-12
Time frame: Change from baseline at 6 months
VR-12
Time frame: Change from baseline at 9 months
VR-12
Time frame: Change from baseline at 12 months
European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)
Time frame: Change from baseline at 3 months
European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)
Time frame: Change from baseline at 6 months
European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)
Time frame: Change from baseline at 9 months
European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)
Time frame: Change from baseline at 12 months
Education Modules Data (Intervention Group Only)
Time frame: through study completion, an average of 1 year.
Education Modules Data (Intervention Group Only)
Time frame: through study completion, an average of 1 year.
System Usability Scale
Time frame: Change from baseline at 3 months
System Usability Scale
Time frame: Change from baseline at 6 months
System Usability Scale
Time frame: Change from baseline at 9 months
System Usability Scale
Time frame: Change from baseline at 12 months
Trail Making Test - Digital
Time frame: Change from baseline at 3 months
Trail Making Test - Digital
Time frame: Change from baseline at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No. Individual data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Smith, PhD study director
Texas A&M University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital fall prevention program in people with Aging, run by Blue Marble Rehab Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Falls per month (time frame: Change from baseline fall rate at 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.