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

Sponsor

Boston University (Other)

Overall Status

Completed

CT.gov ID

NCT04804579

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

Enrollment

Location

Arms

9.4

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infection Alcohol Consumption Falls, Accidental Falls	Behavioral: Fall Prevention Intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 20, 2021

Actual Primary Completion Date :

Aug 1, 2022

Actual Study Completion Date :

Aug 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Fall Prevention Intervention

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

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.

No Intervention: Control Group

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

Outcome Measures

Primary Outcome Measures

Engagement with Intervention [10 weeks (final assessment)]
Number of weekly virtual group intervention sessions attended (of 10 sessions)
Satisfaction with Intervention [10 weeks (final assessment)]
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 [Baseline and 10 weeks (final assessment)]
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. Reported as having experienced 0 falls, 1 fall, 2 falls, 3-5 falls, or more than 5 falls.
Change in Physical Function based on the Short Physical Performance Battery Assessment [Baseline and 10 weeks (final 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 (Fried et al., 2001) [Baseline and 10 weeks (final assessment)]
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 [Baseline and 10 weeks (final assessment)]
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 [including number of days where 4+ drinks (women)/5+drinks (men) were consumed], cocaine, heroin, hallucinogens, phencyclidines, cannabis/marijuana, stimulants/amphetamines, tranquilizers/sedatives, buprenorphine, methadone, other 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.