Clinical trial NCT05011864: Integrated Tele-Behavioral Activation and Fall Prevention for Low-income Homebound Seniors With Depression
Official title: Integrated Tele-Behavioral Activation and Fall Prevention for Low-income Homebound Older Adults With Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression, Unipolar
Fall
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Baylor College of Medicine
First posted: 2021-08-18
Enrollment: 320
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In a pragmatic RCT design with randomization prior to consent rather than the traditional consent-to-randomization design, we will follow six steps in recruitment, enrollment, and intervention delivery: 1) identification of potential participants by case managers / social workers during in-home or telephone assessments and referral to the research team; 2) randomization into TBF (combined Tele-behavioral activation and fall prevention), Tele-BA, FP, and Attention Control (AC: telephone support calls) arms by the research team; 3) calling each person for consent for telephone eligibility screening; 4) conducting in-depth, in-home screening and baseline assessment for eligible, consenting seniors; 5) delivering TBF, Tele-BA alone, FP alone, or AC; and 6) conducting follow-up assessments.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Depression and falls are significantly higher in low-income, racially diverse homebound seniors than in the general older-adult population; however, the existing systems of care are not equipped to address disparities in mental health and fall prevention services for these vulnerable 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. Specific aims are to compare clinical and cost effectiveness of integrated tele-delivered behavioral activation (Tele-BA) and fall prevention (FP) by bachelor's-level lay counselors/coaches to Tele-BA or FP alone and attention control (AC). The current and projected shortages of licensed clinicians and the costs of deploying highly trained professionals pose barriers to providing services to older adults in general and low-income homebound seniors in particular. A more scalable option is to utilize lay counselors/coaches, and our recent clinical trial (1R01MD009675) and a FP pilot study show that lay counselors/coaches are as effective as licensed clinicians. The study participants will be 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. The lay counselors/coaches will be co-located in the HDM program for seamless referral and care coordination. In a 4-arm, pragmatic clinical trial with randomization prior to consent (a preferred public health approach), 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 AC arm will receive 5 weekly telephone check-in calls followed by 4 bimonthly follow-up calls. Study hypotheses are: At 12, 24, and 36 weeks after baseline, (1) TBF will be more effective than Tele-BA or FP alone, and Tele-BA or FP alone will be more effective than AC in reducing depression (the 24-item Hamilton Rating Scale for Depression), falls, and fall injuries; (2) TBF than Tele-BA alone or FP alone will be more effective in reducing disability (WHODAS 2.0) and healthcare and social service use; and (3) TBF will be more cost effective than Tele-BA alone or FP alone. Cost-effectiveness analysis (CEA) will be based on depression free days, prevented falls, and health-related quality adjusted life-year measured by EuroQol-5 (EQ-5D). We will also conduct budget impact analysis (BIA) of TBF relative to Tele-BA or FP. Both CEA and BIA will employ a hybrid public program perspective of the Administration for Community Living and the Centers for Medicare and Medicaid. Public health significance of this study is that it will provide empirical data needed for real-world adoption of an intervention delivery model that targets to intervene for the two most frequent sources of disability acceleration and healthcare use among a rapidly growing, underserved population. (We use the terms older adults and seniors interchangeably because the latter term is frequently used in aging services.)

Eligibility criteria: Inclusion Criteria:

* Age 50+
* English or Spanish proficiency
* 24-item Hamilton Rating Scale for Depression score \> 15
* 12-item Fall Risk Questionnaire score \>4

Exclusion Criteria:

* Recently (\< 4 weeks) initiated or modified antidepressant pharmacotherapy
* High suicide risk
* Probable dementia
* Bipolar disorder
* Substance use/misuse
* Current participation in any psychotherapy or FP program
* Bedbound status

Primary outcomes:
measure: Changes from baseline depressive symptom at 12, 24, and 36 weeks
timeFrame: at 12, 24, and 36 weeks after baseline
measure: Changes from baseline fall count and injury at 12, 24, and 36 weeks
timeFrame: monthly (form 12 weeks to 36 weeks)
measure: Changes from baseline EuroQol-5D score at 12, 24, and 36 weeks
timeFrame: at 12, 24, and 36 weeks after baseline
measure: Changes from baseline physical and mental health service use
timeFrame: at 12, 24, and 36 weeks after baseline
measure: Changes from baseline disability score at 12, 24, and 36 weeks
timeFrame: at 12, 24, and 36 weeks after baseline
measure: Changes from baseline social engagement and activities score at 12, 24, and 36 weeks
timeFrame: at 12, 24, and 36 weeks after baseline
measure: Changes from baseline satisfaction with social roles & activities at 12, 24, and 36 weeks
timeFrame: at 12, 24, and 36 weeks after baseline
Secondary outcomes:
measure: Changes from baseline fear of falling at 12, 24, and 36 weeks
timeFrame: at 12, 24, and 36 weeks after baseline
measure: Changes from baseline exercise frequency at 12, 24, and 36 weeks
timeFrame: at 12, 24, and 36 weeks after baseline
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Namkee G Choi
role: PRINCIPAL_INVESTIGATOR
References: