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Completed

NCT Number: NCT06619496

Health in Motion Pragmatic Clinical Trial - WRAPAROUND

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 compare a digital fall prevention program used in a group setting in the community with traditional community-based fall prevention programs.

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Key information

Conditions

Aging

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheryl Flynn

Altadena, California, 91001, United States

About this study

This study will involve 2 groups. Group 1 will participate in traditional human-led community based fall prevention programs and Group 2 will participate in avatar-led community-based fall prevention program. Metrics of effectiveness include the rate of falls, fall risk, fear of falling, and falls efficacy. Economic benefit will be measured using the European Quality of Life 5-Dimensional Questionnaire, 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
  • Score >30 on the TICS (Telephone Interview for Cognitive Screen) or if lower than 30 has assistance to participate

Exclusion criteria

  • any person who has been told by their physician that they should not exercise

Treatment and study plan

Human-led fall prevention program

Behavioral

Human-led evidence-based fall prevention programs include Matter of Balance, Tai Chi Moving for Better Balance, Walk with Ease, or Arthritis Exercise

Avatar-led fall prevention program

Behavioral

The avatar-led fall prevention program consists of the Otago Exercise Program

Primary outcomes

  1. Rate of falls

    Time frame: change from baseline to end of intervention (about 3 months)

    number of falls during the intervention compared with the self-reported falls at baseline

Secondary outcomes

  1. Timed Up and Go Test

    Time frame: change from baseline to end of intervention (about 3 months)

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

  2. 4 Stage Balance Test

    Time frame: change from baseline to end of intervention (about 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.

  3. One Leg Stand Test

    Time frame: change from baseline to end of intervention (about 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.

  4. 30 Second Sit to Stand Test

    Time frame: change from baseline to end of intervention (about 3 months)

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

  5. Fall Risk Questionnaire

    Time frame: change from baseline to end of intervention (about 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.

  6. Activities Specific Balance Confidence Scale (5 level)

    Time frame: change from baseline to end of intervention (about 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.

  7. Veteran Rand-12 (VR-12)

    Time frame: change from baseline to end of intervention (about 3 months)

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

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

    Time frame: change from baseline to end of intervention (about 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).

  9. Trail Making Test

    Time frame: change from baseline to end of intervention (about 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).

  10. modified Fear of Falling Avoidance Behavior Questionnaire (mFFABQ)

    Time frame: change from baseline to end of intervention (about 3 months)

    This is a standardized self-report assessment that measures behaviors that may be avoided due to a fear of falling. The item scores are summed to form a total score ranging from 0 to 56. Higher scores indicate a higher level of fear of falling avoidance behavior

  11. Upstream Social Isolation Risk Scale (USIR-S)

    Time frame: change from baseline to end of intervention (about 3 months)

    A standardized assessment of social isolation. Lower scores indicate lower risk of social isolation.

Sponsors and collaborators

Lead sponsor

Blue Marble Rehab Inc

Industry

Collaborators

  • National Institute on Aging (NIA)
  • Partners In Care Foundation

Registry information

Official study title

Health in Motion- A Digital Fall Prevention Program Designed to be Delivered as a Wraparound Program

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 1, 2024
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.

View the official ClinicalTrials.gov record (opens in a new tab)

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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