Clinical trial NCT06619496: Health in Motion Pragmatic Clinical Trial - WRAPAROUND
Official title: Health in Motion- A Digital Fall Prevention Program Designed to be Delivered as a Wraparound Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: fall
fall prevention
fall injury
fear of falling
fall efficacy
Lead sponsor: Blue Marble Rehab Inc
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
name: Partners In Care Foundation
First posted: 2024-10-01
Enrollment: 63
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparative prospective observational cohort study
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Rate of falls
timeFrame: change from baseline to end of intervention (about 3 months)
Secondary outcomes:
measure: Timed Up and Go Test
timeFrame: change from baseline to end of intervention (about 3 months)
measure: 4 Stage Balance Test
timeFrame: change from baseline to end of intervention (about 3 months)
measure: One Leg Stand Test
timeFrame: change from baseline to end of intervention (about 3 months)
measure: 30 Second Sit to Stand Test
timeFrame: change from baseline to end of intervention (about 3 months)
measure: Fall Risk Questionnaire
timeFrame: change from baseline to end of intervention (about 3 months)
measure: Activities Specific Balance Confidence Scale (5 level)
timeFrame: change from baseline to end of intervention (about 3 months)
measure: Veteran Rand-12 (VR-12)
timeFrame: change from baseline to end of intervention (about 3 months)
measure: European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)
timeFrame: change from baseline to end of intervention (about 3 months)
measure: Trail Making Test
timeFrame: change from baseline to end of intervention (about 3 months)
measure: modified Fear of Falling Avoidance Behavior Questionnaire (mFFABQ)
timeFrame: change from baseline to end of intervention (about 3 months)
measure: Upstream Social Isolation Risk Scale (USIR-S)
timeFrame: change from baseline to end of intervention (about 3 months)
Other outcomes:
Locations:
city: Altadena
country: United States
facility: Sheryl Flynn
state: California
Study officials:
References: