Health in Motion Pragmatic Clinical Trial - WRAPAROUND

NCT06619496 | Completed

• 2 other identifiers: AG043191-4. v1-wraparound2R44AG043191-04A1
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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

Conditions

Aging

Keywords

fall; fall prevention; fall injury; fear of falling; fall efficacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Timed Up and Go Test

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

• 4 Stage Balance Test

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

• One Leg Stand Test

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

• 30 Second Sit to Stand Test

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

• Fall Risk Questionnaire

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

Study Arms (2)

Human-led fall prevention programs

ACTIVE COMPARATOR

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

Avatar-led fall prevention program

EXPERIMENTAL

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

Interventions

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

Human-led fall prevention programs

Avatar-led fall prevention program BEHAVIORAL

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

Avatar-led fall prevention program

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age of 55 and older
• Score \>30 on the TICS (Telephone Interview for Cognitive Screen) or if lower than 30 has assistance to participate

You may not qualify if:

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

Sponsors & Collaborators

• Blue Marble Rehab Inc: lead
• National Institute on Aging (NIA): collaborator
• Partners In Care Foundation: collaborator

Study Sites (1)

Sheryl Flynn

Altadena, California, 91001, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: comparative prospective observational cohort study

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 1, 2024
• Study Start: October 24, 2022
• Primary Completion: May 14, 2024
• Study Completion: July 1, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)