Alcohol Consumption, Falls, Falls, Accidental, HIV Infection
Conditions
Keywords
HIV Infection, Alcohol Consumption, Falls, Accidental, Falls, Substance Use, Intervention Study
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.
Interventions
BEHAVIORALFall 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.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Self Reported Falls | Baseline and 10 weeks (final assessment) | 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 | 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 | 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 \[number of days where 4+ drinks (women)/5+drinks (men) were consumed\], 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
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. | 12 |
| Control Group Participants will be provided with an educational pamphlet that includes resources related to falls and alcohol use. | 11 |
| Total | 23 |
Baseline characteristics
| Characteristic | Control Group | Total | Fall Prevention Intervention |
|---|---|---|---|
| Age, Continuous | 58.5 years STANDARD_DEVIATION 8.2 | 57.9 years STANDARD_DEVIATION 8.1 | 57.4 years STANDARD_DEVIATION 8.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 21 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 13 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 5 Participants | 8 Participants | 3 Participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Male | 7 Participants | 15 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 11 |
| other Total, other adverse events | 0 / 12 | 0 / 11 |
| serious Total, serious adverse events | 0 / 12 | 0 / 11 |
Outcome results
Primary
Engagement With Intervention
Number of weekly virtual group intervention sessions attended (of 10 sessions)
Time frame: 10 weeks (final assessment)
Population: Analysis population includes participants assigned to the Fall Prevention Intervention who completed the 10-week follow-up research assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fall Prevention Intervention | Engagement With Intervention | 3.27 intervention sessions | Standard Deviation 3.44 |
Primary
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.
Time frame: 10 weeks (final assessment)
Population: Analysis population includes participants assigned to the Fall Prevention Intervention who completed the 10-week follow-up research assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fall Prevention Intervention | Satisfaction With Intervention | 30.35 score on a scale | Standard Deviation 1.57 |
Secondary
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).
Time frame: Baseline and 10 weeks (final assessment)
Population: Participants who completed the 10-week follow-up research assessment with complete (non-missing) data on all components of the Frailty Phenotype
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fall Prevention Intervention | Change in Fried's Frailty Phenotype | -0.09 score on a scale | Standard Deviation 1.58 |
| Control Group | Change in Fried's Frailty Phenotype | 0.3 score on a scale | Standard Deviation 0.82 |
Secondary
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.
Time frame: Baseline and 10 weeks (final assessment)
Population: Participants who completed the 10-week follow-up research assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fall Prevention Intervention | Change in Number of Days of Alcohol Use and Other Drug Use in the Past 30 Days | -1.36 days | Standard Deviation 5.64 |
| Control Group | Change in Number of Days of Alcohol Use and Other Drug Use in the Past 30 Days | -0.45 days | Standard Deviation 7.12 |
Secondary
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.
Time frame: Baseline and 10 weeks (final assessment)
Population: Participants who completed the 10-week follow-up research assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fall Prevention Intervention | Change in Physical Function Based on the Short Physical Performance Battery Assessment | 0.82 score on a scale | Standard Deviation 1.25 |
| Control Group | Change in Physical Function Based on the Short Physical Performance Battery Assessment | 0.36 score on a scale | Standard Deviation 1.29 |
Secondary
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.
Time frame: Baseline and 10 weeks (final assessment)
Population: Participants who completed the 10-week follow-up research assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fall Prevention Intervention | Change in Self Reported Falls | -38.6 Percentage of participants |
| Control Group | Change in Self Reported Falls | 0 Percentage of participants |