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

NCT04804579 | Completed Results DMC

• 2 other identifiers: H-41041U01AA020784
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection; Alcohol Consumption; Falls, Accidental; Falls

Keywords

HIV Infection; Alcohol Consumption; Falls, Accidental; Falls; Substance Use; Intervention Study

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (4)

• Change in Self Reported Falls

  Baseline and 10 weeks (final assessment)

• 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)

Study Arms (2)

Fall Prevention Intervention

EXPERIMENTAL

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).

Behavioral: Fall Prevention Intervention

Control Group

NO INTERVENTION

Participants will be provided with an educational pamphlet that includes resources related to falls and alcohol use.

Interventions

Fall Prevention Intervention BEHAVIORAL

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.

Fall Prevention Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Requires wheelchair for mobility

Sponsors & Collaborators

• Boston University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Boston University Medical Campus

Boston, Massachusetts, 02118, United States

Location

Related Publications (2)

• 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.

  PMID: 38554013 DERIVED

• 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.

  PMID: 36578450 DERIVED

MeSH Terms

Conditions

HIV Infections; Alcohol Drinking; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Drinking Behavior; Behavior; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Theresa W. Kim MD
• Organization: Boston University School of Public Health

therkim@bu.edu

(617) 414-6932

Study Officials

• Theresa W Kim, MD

  Boston University

  PRINCIPAL INVESTIGATOR

• Simone Gill, PhD

  Boston University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 18, 2021
• Study Start: October 20, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: June 29, 2023
• Results First Posted: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)