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Boston Alcohol Research Collaboration on HIV/AIDS (ARCH) Frailty, Functional Impairment, Falls, and Fractures (4F) Fall Prevention Intervention Pilot Study
Sponsor study identifier
Secondary identifiers
NIH
interventional
23
1 country
1
Study Start
October 20, 2021
Actual (reported)Primary Completion
August 1, 2022
Actual (reported)Study Completion
August 1, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 16, 2021
Actual (reported)March 18, 2021
Actual (reported)October 20, 2021
Actual (reported)August 1, 2022
Actual (reported)August 1, 2022
Actual (reported)June 29, 2023
Actual (reported)Engagement With Intervention
Number of weekly virtual group intervention sessions attended (of 10 sessions)
10 weeks (final assessment)
Satisfaction With Intervention
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.
10 weeks (final assessment)
Change in Self Reported Falls
Baseline and 10 weeks (final assessment)
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).
Participants will be provided with an educational pamphlet that includes resources related to falls and alcohol use.
The intervention will aim to reduce fall risk through weekly virtual group meetings and at-home exercise assignments to address physical and environmental factors that may put participants at a higher risk of experiencing a fall.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Boston University Medical Campus
Boston, Massachusetts, 02118, United States
Gill SV, Shin D, Kim TW, Magane KM, Hereen T, Winter M, Helfrich C, Saitz R. A Fall Prevention Feasibility Trial for People With HIV and Alcohol Use. OTJR (Thorofare N J). 2025 Jan;45(1):85-94. doi: 10.1177/15394492241238956. Epub 2024 Mar 30.
Shin D, Gill SV, Kim TW, Magane KM, Mason T, Heeren T, Winter M, Helfrich C, Saitz R. Study Protocol for a Pilot Randomized Trial of a Virtual Occupational Therapy Fall Prevention Intervention for People With HIV and Alcohol Use. Subst Abuse. 2022 Dec 23;16:11782218221145548. doi: 10.1177/11782218221145548. eCollection 2022.
Theresa W Kim, MD
Boston University
Simone Gill, PhD
Boston University
23 participants (actual enrollment reported by the registry).
First Submitted
March 16, 2021
First Posted
March 18, 2021
Study Start
October 20, 2021
Actual (reported)Change in Physical Function Based on the Short Physical Performance Battery Assessment
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)
Contact the study team to confirm eligibility.
Primary Completion
August 1, 2022
Actual (reported)Study Completion
August 1, 2022
Actual (reported)Last Updated
June 29, 2023
Results First Posted
June 29, 2023
Record last verified: 2023-06
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Source: ClinicalTrials.gov.
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