Clinical trial NCT04804579: Boston ARCH 4F Intervention to Reduce Fall Risk in People With HIV and Alcohol Use
Official title: Boston Alcohol Research Collaboration on HIV/AIDS (ARCH) Frailty, Functional Impairment, Falls, and Fractures (4F) Fall Prevention Intervention Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Alcohol Consumption
Falls, Accidental
Falls
Keywords: HIV Infection
Alcohol Consumption
Falls, Accidental
Falls
Substance Use
Intervention Study
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-03-18
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Engagement With Intervention
timeFrame: 10 weeks (final assessment)
measure: Satisfaction With Intervention
timeFrame: 10 weeks (final assessment)
Secondary outcomes:
measure: Change in Self Reported Falls
timeFrame: Baseline and 10 weeks (final assessment)
measure: Change in Physical Function Based on the Short Physical Performance Battery Assessment
timeFrame: Baseline and 10 weeks (final assessment)
measure: Change in Fried's Frailty Phenotype
timeFrame: Baseline and 10 weeks (final assessment)
measure: Change in Number of Days of Alcohol Use and Other Drug Use in the Past 30 Days
timeFrame: Baseline and 10 weeks (final assessment)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Medical Campus
state: Massachusetts
Study officials:
affiliation: Boston University
name: Theresa W Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Simone Gill, PhD
role: STUDY_DIRECTOR
References: