Integrated Tele-Behavioral Activation and Fall Prevention for Low-income Homebound Seniors With Depression

Part of paid clinical trials in Austin, Texas.

Sponsor
University of Texas at Austin
Study ID
NCT05011864
Status
Recruiting
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Conditions

  • Depression, Unipolar
  • Fall

Eligibility Criteria

Sex
ALL
Age
50 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Behavioral Activation — BEHAVIORAL
    In BA, depressive symptoms are viewed as depressive behaviors. Compared to those without depression, people with depression engage in fewer overt behaviors that provide positive reinforcement and pleasure/enjoyment and in more behaviors that function to escape or avoid aversive stimuli (e.g., staying in bed all day).55-59 Thus, BA is aimed at increasing and reinforcing meaningful, healthy, and enjoyable behaviors while decreasing depressive behaviors and is well-suited to help depressed, disabled older adults increase mood-enhancing activities, self-care management skills, and social connectedness.
  • Fall Prevention — BEHAVIORAL
    Following FP psychoeducation based on the Centers for Disease Control and Prevention (CDC)'s STEADI tool kits, lay coaches will assist clients in implementing evidence-based FP strategies that have been adapted for low-income homebound seniors. These include referrals to healthcare providers as needed, home safety checks, practice of safe ambulation/transfer and mobility aid use, medication review, and in-home exercise routines with an innovative, gamified tablet-based exercise app for balance and strength building.
  • Telephone support — OTHER
    Subjects in this arm will receive 9 weekly support calls last 30 minutes each. These calls are intended to provide an opportunity for social support and check safety.

Study Details

This study will test clinical and cost effectiveness of an integrated tele- and bachelor's-level counselor/coach delivered behavioral activation (BA) and fall prevention (FP) for low-income homebound older adults. The long-term objective of the proposed study is to improve access to depression treatment and fall prevention for growing numbers of low-income homebound seniors. We plan to recruit 320 low-income, racially diverse homebound seniors who are served by a home-delivered meal (HDM) program and other aging-service agencies in Central Texas. In a 4-arm, pragmatic clinical trial with randomization prior to consent, the participants in the integrated Tele-BA and FP (TBF hereafter) arm will receive 5 Tele-BA sessions and 4 in-home FP sessions. Those in the Tele-BA or FP alone arms will receive the respective intervention and 4 bimonthly telephone check-in (booster) calls, and those in the Attention Control (AC) arm will receive 5 weekly telephone check-in calls followed by 4 bimonthly follow-up calls. Follow-up assessments will be at 12, 24, and 36 weeks after baseline.

Key Dates

Start date
Nov 1, 2021
Status verified
Jan 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tele-Behavioral Activation and Fall Prevention
    Each subject will participate in five 1-hour, weekly Tele-BA sessions followed by four 1-1.5 hour, weekly in-home FP sessions with the same provider
  • Experimental: Tele-Behavioral Activation
    Each subject in this arm will participate in five 1-hour, weekly Tele-BA sessions followed by four weekly check-in (booster) calls of up to 30 minutes each.
  • Experimental: Fall Prevention
    Each subject will participate in four 1-1.5 hour, weekly in-home (or tele, if COVID continues) FP sessions followed by four weekly check-in (booster) calls of up to 30 minutes each.
  • Active Comparator: Attention Control (Telephone Support Call)
    AC participants in this study will receive five weekly telephone calls of up to 45 minutes each and four weekly check-in calls of up to 30 minutes each from a research assistant (RA) who will employ genuine regard and attentive listening and provide nonspecific support.

Primary Outcome Measure

Changes from baseline depressive symptom at 12, 24, and 36 weeks [ Time Frame: at 12, 24, and 36 weeks after baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas at AustinAustinTexas78712-0358
Namkee G. Choi, PhD
[email protected]
512-232-9590
Namkee G. Choi, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Texas at Austin· Austin, TX

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