Boston University Medical Campus
Boston, Massachusetts, 02118, United States
NCT Number: NCT04804579
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02118, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 10 weeks (final assessment)
Number of weekly virtual group intervention sessions attended (of 10 sessions)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Boston University
Other
Boston Alcohol Research Collaboration on HIV/AIDS (ARCH) Frailty, Functional Impairment, Falls, and Fractures (4F) Fall Prevention Intervention Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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