Boston Alcohol Research Collaboration on HIV/AIDS (ARCH) Frailty, Functional Impairment, Falls, and Fractures (4F) Fall Prevention Intervention Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boston University
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Engagement With Intervention
Study Overview
Brief Summary
This study is being conducted to assess the acceptability and feasibility of a randomized trial of a 10 week virtual intervention to reduce fall risk in people with HIV who consume alcohol. The hypothesis is that this randomized trial of the fall prevention intervention will be found to be feasible and acceptable in this pilot stage.
Standardized assessments will be administered in-person at Boston University Medical Campus to assess various domains including fall risk, fear of falling, physical performance measures (such as grip strength, balance, and gait speed), substance use, and other related measures. The intervention has 3 main components: home exercises, virtual group sessions and weekly phone check-ins. Home exercise will be customized to match the current fitness level of participants. Participants will be asked to complete assigned exercises 3 times per week. Additionally, there will be a weekly virtual group session led by an Occupational Therapist trained in group facilitation via Zoom. The virtual group sessions will be used to help answer any questions and lead a discussion around challenges related to falls. Finally, a member of the research team will check-in with participants once per week to answer any remaining questions that participants have, provide individual feedback on exercises, and set up reminders for the upcoming week. Reminders will be tailored to the individual participant's needs to remind the participant to complete the intervention's components.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Prior or current participant in the Boston ARCH 4F Cohort
- •Any alcohol consumption in the last 30 days using Addiction Severity Index
- •Deemed a Fall Risk using the CDC STEADI Fall Risk Assessment Form
- •Has reliable access to a phone or computer with internet connection
Exclusion Criteria
- •Requires wheelchair for mobility
Arms & Interventions
Fall Prevention Intervention
The Intervention involves 3 primary components: virtual group sessions, at-home exercises, and weekly phone check-ins.
Virtual Group Session will be held via phone/video call for approximately 30 minutes per week for 10 weeks.
At-Home Exercises will be assigned by a registered occupational therapist member of the study team, and participants will be instructed to complete them independently at home 3 times per week. Participants will record the exercises that they complete.
Weekly Phone Check-Ins will occur once per week. These check-ins will be used to provide support and problem solving as needed, and individualized reminder systems will be set up to prompt the participant to engage in their weekly exercises (e.g., set up alarm on phone, notifications through calendar app).
Intervention: Fall Prevention Intervention (Behavioral)
Control Group
Participants will be provided with an educational pamphlet that includes resources related to falls and alcohol use.
Outcomes
Primary Outcomes
Engagement With Intervention
Time Frame: 10 weeks (final assessment)
Number of weekly virtual group intervention sessions attended (of 10 sessions)
Satisfaction With Intervention
Time Frame: 10 weeks (final assessment)
Measured using the Client Satisfaction Questionnaire (CSQ-8), which includes 8 items that yield a single score measuring a single dimension of overall satisfaction. Each item is assessed using a Likert scale that ranges from 1-4. Scores range from 8-32, with higher values indicating greater satisfaction.
Secondary Outcomes
- Change in Physical Function Based on the Short Physical Performance Battery Assessment(Baseline and 10 weeks (final assessment))
- Change in Self Reported Falls(Baseline and 10 weeks (final assessment))
- Change in Fried's Frailty Phenotype(Baseline and 10 weeks (final assessment))
- Change in Number of Days of Alcohol Use and Other Drug Use in the Past 30 Days(Baseline and 10 weeks (final assessment))