Health in Motion Pragmatic Clinical Trial - WRAPAROUND

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

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Behavioral: Human-led fall prevention program; Behavioral: Avatar-led fall prevention program

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Altadena, California, United States, 91001
      • Sheryl Flynn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

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
Active Comparator: Human-led fall prevention programs; Participants will complete any human-led fall prevention program of their choice, in a group setting either in-person or via Zoom.	Behavioral: Human-led fall prevention program; Human-led evidence-based fall prevention programs include Matter of Balance, Tai Chi Moving for Better Balance, Walk with Ease, or Arthritis Exercise
Experimental: Avatar-led fall prevention program; Participants will complete an avatar-led fall prevention program at their local community center or community room of their housing complex	Behavioral: Avatar-led fall prevention program; The avatar-led fall prevention program consists of the Otago Exercise Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of falls	number of falls during the intervention compared with the self-reported falls at baseline	change from baseline to end of intervention (about 3 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 to end of intervention (about 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 to end of intervention (about 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 to end of intervention (about 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 to end of intervention (about 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 to end of intervention (about 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 to end of intervention (about 3 months)
Veteran Rand-12 (VR-12)	This questionnaire measures quality of life over the past 4 weeks.	change from baseline to end of intervention (about 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).	change from baseline to end of intervention (about 3 months)
Trail Making Test	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 to end of intervention (about 3 months)
modified Fear of Falling Avoidance Behavior Questionnaire (mFFABQ)	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	change from baseline to end of intervention (about 3 months)
Upstream Social Isolation Risk Scale (USIR-S)	A standardized assessment of social isolation. Lower scores indicate lower risk of social isolation.	change from baseline to end of intervention (about 3 months)

Collaborators and Investigators

• Sponsor: Blue Marble Rehab Inc
• Collaborators: National Institute on Aging (NIA); Partners In Care Foundation

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2022
• Primary Completion (Actual): May 14, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

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: AG043191-4. v1-wraparound; 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