search
Back to results

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

Primary Purpose

HIV Infection, Alcohol Consumption, Falls, Accidental

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fall Prevention Intervention
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infection focused on measuring HIV Infection, Alcohol Consumption, Falls, Accidental, Falls, Substance Use, Intervention Study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Boston University Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fall Prevention Intervention

Control Group

Arm 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).

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

Outcomes

Primary Outcome Measures

Engagement With Intervention
Number of weekly virtual group intervention sessions attended (of 10 sessions)
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.

Secondary Outcome Measures

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.
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.
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).
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.

Full Information

First Posted
March 16, 2021
Last Updated
June 27, 2023
Sponsor
Boston University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
search

1. Study Identification

Unique Protocol Identification Number
NCT04804579
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Alcohol Consumption, Falls, Accidental, Falls
Keywords
HIV Infection, Alcohol Consumption, Falls, Accidental, Falls, Substance Use, Intervention Study

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fall Prevention Intervention
Arm Type
Experimental
Arm 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).
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants will be provided with an educational pamphlet that includes resources related to falls and alcohol use.
Intervention Type
Behavioral
Intervention Name(s)
Fall Prevention Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Engagement With Intervention
Description
Number of weekly virtual group intervention sessions attended (of 10 sessions)
Time Frame
10 weeks (final assessment)
Title
Satisfaction With Intervention
Description
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.
Time Frame
10 weeks (final assessment)
Secondary Outcome Measure Information:
Title
Change in Self Reported Falls
Description
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.
Time Frame
Baseline and 10 weeks (final assessment)
Title
Change in Physical Function Based on the Short Physical Performance Battery Assessment
Description
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.
Time Frame
Baseline and 10 weeks (final assessment)
Title
Change in Fried's Frailty Phenotype
Description
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).
Time Frame
Baseline and 10 weeks (final assessment)
Title
Change in Number of Days of Alcohol Use and Other Drug Use in the Past 30 Days
Description
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.
Time Frame
Baseline and 10 weeks (final assessment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa W Kim, MD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simone Gill, PhD
Organizational Affiliation
Boston University
Official's Role
Study Director
Facility Information:
Facility Name
Boston University Medical Campus
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs