Purpose:
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.
Study summary:
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.)
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