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Boston ARCH 4F Intervention to Reduce Fall Risk in People With HIV and Alcohol Use

Boston University logo

Boston University

Status

Completed

Conditions

Alcohol Consumption
Falls, Accidental
HIV Infection
Falls

Treatments

Behavioral: Fall Prevention Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04804579
H-41041
U01AA020784 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

23 participants in 2 patient groups

Fall Prevention Intervention
Experimental group
Description:
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).
Treatment:
Behavioral: Fall Prevention Intervention
Control Group
No Intervention group
Description:
Participants will be provided with an educational pamphlet that includes resources related to falls and alcohol use.

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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