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

NCT ID: NCT05011864

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2026-12-31

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.)

Conditions

Depression, Unipolar; Fall

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Behavioral Activation

Intervention Type: 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

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Behavioral Activation

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Fall Prevention

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Telephone support

Intervention Type: 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.

Interventions

Behavioral Activation

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.

Intervention Type: BEHAVIORAL

Fall Prevention

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.

Intervention Type: BEHAVIORAL

Telephone support

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.

Intervention Type: OTHER

Other Intervention Names

Tele-BA; FP; AC

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Namkee Choi

Professor and Louis and Ann Wolens Centennial Chair in Gerontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Namkee G Choi

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

University of Texas at Austin

Austin, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Namkee G Choi, PhD

Role: CONTACT

nchoi@austin.utexas.edu

5122329590

Kelly Vences, BSW

Role: CONTACT

kelly.vences@utexas.edu

5122320604

Facility Contacts

Namkee G. Choi, PhD

Role: primary

nchoi@mail.utexas.edu

512-232-9590

Other Identifiers

2R01MD009675-07

Identifier Type: NIH

Identifier Source: org_study_id

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