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Completed

NCT Number: NCT05016141

Health in Motion- A Pragmatic Clinical Trial- 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.

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Key information

Conditions

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blue Marble Health

Altadena, California, 91001, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

digital fall prevention program

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Timed Up and Go Test

    Time frame: Change from baseline at 3 months

    Time taken to stand up from a seated position, walk 10 feet, turn around, return to the chair, sit down

  2. Timed Up and Go Test

    Time frame: Change from baseline at 6 months

    Time taken to stand up from a seated position, walk 10 feet, turn around, return to the chair, sit down

  3. Timed Up and Go Test

    Time frame: Change from baseline at 9 months

    Time taken to stand up from a seated position, walk 10 feet, turn around, return to the chair, sit down

  4. Timed Up and Go Test

    Time frame: Change from baseline at 12 months

    Time taken to stand up from a seated position, walk 10 feet, turn around, return to the chair, sit down

  5. 4 Stage Balance Test

    Time frame: Change from baseline at 3 months

    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.

  6. 4 Stage Balance Test

    Time frame: Change from baseline at 6 months

    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.

  7. 4 Stage Balance Test

    Time frame: Change from baseline at 9 months

    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.

  8. 4 Stage Balance Test

    Time frame: Change from baseline at 12 months

    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.

  9. One Leg Stand Test

    Time frame: Change from baseline at 3 months

    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.

  10. One Leg Stand Test

    Time frame: Change from baseline at 6 months

    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.

  11. One Leg Stand Test

    Time frame: Change from baseline at 9 months

    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.

  12. One Leg Stand Test

    Time frame: Change from baseline at 12 months

    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.

  13. 30 Second Sit to Stand Test

    Time frame: Change from baseline at 3 months

    This test measures the number of times a participant can stand up from a seated position in 30 seconds.

  14. 30 Second Sit to Stand Test

    Time frame: Change from baseline at 6 months

    This test measures the number of times a participant can stand up from a seated position in 30 seconds.

  15. 30 Second Sit to Stand Test

    Time frame: Change from baseline at 9 months

    This test measures the number of times a participant can stand up from a seated position in 30 seconds.

  16. 30 Second Sit to Stand Test

    Time frame: Change from baseline at 12 months

    This test measures the number of times a participant can stand up from a seated position in 30 seconds.

  17. Fall Risk Questionnaire

    Time frame: Change from baseline at 3 months

    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.

  18. Fall Risk Questionnaire

    Time frame: Change from baseline at 6 months

    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.

  19. Fall Risk Questionnaire

    Time frame: Change from baseline at 9 months

    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.

  20. Fall Risk Questionnaire

    Time frame: Change from baseline at 12 months

    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.

  21. Activities Specific Balance Confidence Scale 5 Level

    Time frame: Change from baseline at 3 months

    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.

  22. Activities Specific Balance Confidence Scale 5 Level

    Time frame: Change from baseline at 6 months

    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.

  23. Activities Specific Balance Confidence Scale 5 Level

    Time frame: Change from baseline at 9 months

    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.

  24. Activities Specific Balance Confidence Scale 5 Level

    Time frame: Change from baseline at 12 months

    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.

  25. VR-12

    Time frame: Change from baseline at 3 months

    This questionnaire measures quality of life over the past 4 weeks.

  26. VR-12

    Time frame: Change from baseline at 6 months

    This questionnaire measures quality of life over the past 4 weeks.

  27. VR-12

    Time frame: Change from baseline at 9 months

    This questionnaire measures quality of life over the past 4 weeks.

  28. VR-12

    Time frame: Change from baseline at 12 months

    This questionnaire measures quality of life over the past 4 weeks.

  29. European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)

    Time frame: Change from baseline at 3 months

    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.

  30. European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)

    Time frame: Change from baseline at 6 months

    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.

  31. European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)

    Time frame: Change from baseline at 9 months

    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.

  32. European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)

    Time frame: Change from baseline at 12 months

    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.

  33. Education Modules Data (Intervention Group Only)

    Time frame: through study completion, an average of 1 year.

    Time Taken: The Health in Motion App captures data time taken to complete the lessons.

  34. Education Modules Data (Intervention Group Only)

    Time frame: through study completion, an average of 1 year.

    Qualitative Analysis of text entries.

  35. System Usability Scale

    Time frame: Change from baseline at 3 months

    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.

  36. System Usability Scale

    Time frame: Change from baseline at 6 months

    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.

  37. System Usability Scale

    Time frame: Change from baseline at 9 months

    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.

  38. System Usability Scale

    Time frame: Change from baseline at 12 months

    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.

  39. Trail Making Test - Digital

    Time frame: Change from baseline at 3 months

    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).

  40. Trail Making Test - Digital

    Time frame: Change from baseline at 6 months

    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).

  41. Trail Making Test - Digital

    Time frame: Change from baseline at 9 months

    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).

  42. Trail Making Test - Digital

    Time frame: Change from baseline at 12 months

    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).

  43. Modified Fear of Falling Avoidance Behavior Questionnaire

    Time frame: Change from baseline at 3 months

    This is a standardized self-report assessment that measures behaviors that may be avoided due to a fear of falling

  44. Modified Fear of Falling Avoidance Behavior Questionnaire

    Time frame: Change from baseline at 6 months

    This is a standardized self-report assessment that measures behaviors that may be avoided due to a fear of falling

  45. Modified Fear of Falling Avoidance Behavior Questionnaire

    Time frame: Change from baseline at 9 months

    This is a standardized self-report assessment that measures behaviors that may be avoided due to a fear of falling

  46. Modified Fear of Falling Avoidance Behavior Questionnaire

    Time frame: Change from baseline at 12 months

    This is a standardized self-report assessment that measures behaviors that may be avoided due to a fear of falling

  47. Depression Screen

    Time frame: Change from baseline at 3 months

    The Depression Screen is a 2-item questionnaire that asks about how the person has been feeling over the past 2 weeks.

  48. Depression Screen

    Time frame: Change from baseline at 6 months

    The Depression Screen is a 2-item questionnaire that asks about how the person has been feeling over the past 2 weeks.

  49. Depression Screen

    Time frame: Change from baseline at 9 months

    The Depression Screen is a 2-item questionnaire that asks about how the person has been feeling over the past 2 weeks.

  50. Depression Screen

    Time frame: Change from baseline at 12 months

    The Depression Screen is a 2-item questionnaire that asks about how the person has been feeling over the past 2 weeks.

  51. Adherence to Exercise Program (Intervention Group Only)

    Time frame: through study completion, an average of 1 year

    Average number of days per week the exercise program was completed

  52. Total number of repetitions of all exercises completed

    Time frame: through study completion, an average of 1 year

    Total number of repetitions of all exercises completed

  53. Adherence to Education Modules

    Time frame: through study completion, an average of 1 year

    Total number of education modules completed

Sponsors and collaborators

Lead sponsor

Blue Marble Rehab Inc

Industry

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Aug 23, 2021
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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