Skip to main content
Clinical Trials/NCT04804579
NCT04804579
Completed
Not Applicable

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

Boston University1 site in 1 country23 target enrollmentOctober 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infection
Sponsor
Boston University
Enrollment
23
Locations
1
Primary Endpoint
Engagement With Intervention
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2021
End Date
August 1, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Engagement With Intervention

Time Frame: 10 weeks (final assessment)

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

Satisfaction With Intervention

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.

Secondary Outcomes

  • Change in Physical Function Based on the Short Physical Performance Battery Assessment(Baseline and 10 weeks (final assessment))
  • Change in Self Reported Falls(Baseline and 10 weeks (final assessment))
  • Change in Fried's Frailty Phenotype(Baseline and 10 weeks (final assessment))
  • Change in Number of Days of Alcohol Use and Other Drug Use in the Past 30 Days(Baseline and 10 weeks (final assessment))

Study Sites (1)

Loading locations...

Similar Trials