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HIV InfectionNCT04804579

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

A study testing Fall Prevention Intervention in people with HIV Infection and Alcohol Consumption, run by Boston University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fall Prevention Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
20 Oct 2021to 1 Aug 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Requires wheelchair for mobility

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Boston University Medical Campus

    Boston, Massachusetts, 02118

Other trials in United States

About this study

Official title: Boston Alcohol Research Collaboration on HIV/AIDS (ARCH) Frailty, Functional Impairment, Falls, and Fractures (4F) Fall Prevention Intervention Pilot Study

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.

Being tested
Fall Prevention Intervention
Keywords
HIV Infection, Alcohol Consumption, Falls, Accidental, Falls, Substance Use, Intervention Study
Medical subject headings
HIV Infections, Alcohol Drinking, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fall Prevention InterventionBehavioural

    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.

Study groups in NCT04804579
Study groupRoleWhat they receive
Fall Prevention InterventionExperimentalThe 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).
Receives: Behavioral: Fall Prevention Intervention
Control GroupNo interventionParticipants will be provided with an educational pamphlet that includes resources related to falls and alcohol use.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Engagement With Intervention

    Number of weekly virtual group intervention sessions attended (of 10 sessions)

    Measured: 10 weeks (final assessment)

  2. 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.

    Measured: 10 weeks (final assessment)

Secondary outcomes (4)

  1. Change in Self Reported Falls

    A fall is defined as an unexpected event, including a slip or a trip, in which a participant lost their balance and landed on the floor, ground, or lower level, or hit an object like a table or a chair. Participants self-report as having experienced 0 falls, 1 fall, 2 falls, 3-5 falls, or more than 5 falls. Results were dichotomized as no falls, or 1 or more fall. Outcome results are reported as change from baseline to follow-up in the percentage of participants with at least one fall.

    Measured: Baseline and 10 weeks (final assessment)

  2. Change in Physical Function Based on the Short Physical Performance Battery Assessment

    A composite score based on balance (the ability to stand for 10 seconds with feet in 3 different positions: side-by-side, semi-tandem, and tandem), gait speed (timed trial of a 4m walk), and chair rises (time to rise from a chair 5 times). The score ranges from 0-12, with a higher score indicating better physical function.

    Measured: Baseline and 10 weeks (final assessment)

  3. Change in Fried's Frailty Phenotype

    Frailty is defined as the presence of five components: Weakness, defined as having a low grip strength measured with a dynamometer; slowness, defined as having a slow walking speed measured using a 20 meter gait speed assessment; exhaustion, defined as answering "Most or all of the time (5-7 days)" to at least one of two questions from the Center for Epidemiologic Studies (CESD-10) scale ("How often do you feel like everything you did was an effort?" and "How often did you feel like you could not get going?"); Low physical activity, defined as answering "Yes, limited a lot" to the question "Does your health limit you in vigorous activities, such as running, lifting heavy objects, participating in strenuous sports?"; and unintentional weight loss, defined as answering "Yes" to the question "In the past year, have you lost more than 10 pounds unintentionally?". Stages of frailty are categorized as: Non-frail (score 0), Pre-frail (score 1-2), and Frail (score 3-5).

    Measured: Baseline and 10 weeks (final assessment)

  4. Change in Number of Days of Alcohol Use and Other Drug Use in the Past 30 Days

    Measured using the past 30 day alcohol/drug use section of the Addiction Severity Index (ASI), a validated instrument. The past 30 day alcohol/drug use section of the ASI measures the number of days of substance use in the past 30 days. The substances assessed by the ASI include: alcohol [number of days where 4+ drinks (women)/5+drinks (men) were consumed], cocaine, heroin, hallucinogens, phencyclidines, cannabis/marijuana, stimulants/amphetamines, tranquilizers/sedatives, non-prescribed buprenorphine, non-prescribed methadone, other non-prescribed prescription opioids, inhalants, synthetic marijuana/K2/spice, miscellaneous. Number of days range from 0-30 for each substance, with a higher number of days indicating more frequent substance use.

    Measured: Baseline and 10 weeks (final assessment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2021
  2. Study start20 Oct 2021
  3. Primary completion1 Aug 2022
  4. Study completion1 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04804579
Sponsor's protocol ID
H-41041
Other IDs
U01AA020784
Status last verified
Jun 2023
First submitted
16 Mar 2021
Last updated
29 Jun 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38554013

  • 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.

    PubMed 36578450

Questions about this trial

What is this clinical trial studying?

A study testing Fall Prevention Intervention in people with HIV Infection and Alcohol Consumption, run by Boston University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Engagement With Intervention (time frame: 10 weeks (final assessment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04804579, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.

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