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

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ClinicalTrials.gov Identifier: NCT05011864
Recruitment Status : Recruiting
First Posted : August 18, 2021
Last Update Posted : February 16, 2023
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
Namkee Choi, University of Texas at Austin

Study Description
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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.

Condition or disease Intervention/treatment Phase
Depression, Unipolar Fall Behavioral: Behavioral Activation Behavioral: Fall Prevention Other: Telephone support Not Applicable

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.)
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Integrated Tele-Behavioral Activation and Fall Prevention for Low-income Homebound Older Adults With Depression
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arms and Interventions
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Arm Intervention/treatment
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
 Behavioral: 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.
Other Name: Tele-BA

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.
Other Name: FP
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.
 Behavioral: 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.
Other Name: Tele-BA
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.
 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.
Other Name: FP
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.
 Other: 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.
Other Name: AC


Outcome Measures
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Primary Outcome Measures :
  1. Changes from baseline depressive symptom at 12, 24, and 36 weeks [ Time Frame: at 12, 24, and 36 weeks after baseline ]
    24-item Hamilton Rating Scale for Depression score (score range: 15-40; decreased score since baseline is a positive outcome)

  2. Changes from baseline fall count and injury at 12, 24, and 36 weeks [ Time Frame: monthly (form 12 weeks to 36 weeks) ]
    Changes in six monthly falls calendar data (reduced number of falls since baseline is a positive outcome)

  3. Changes from baseline EuroQol-5D score at 12, 24, and 36 weeks [ Time Frame: at 12, 24, and 36 weeks after baseline ]
    Cost-effectiveness measure (score range: 0-20; decreased score since baseline is a positive outcome)

  4. Changes from baseline physical and mental health service use [ Time Frame: at 12, 24, and 36 weeks after baseline ]
    Changes in Cornell Services index data (decreased ED visits and hospitalization since baseline is a positive outcome)

  5. Changes from baseline disability score at 12, 24, and 36 weeks [ Time Frame: at 12, 24, and 36 weeks after baseline ]
    Changes in 12-item World Health Organization Disability Assessment Schedule score (score range: 0-46; decreased score since baseline is a positive outcome)

  6. Changes from baseline social engagement and activities score at 12, 24, and 36 weeks [ Time Frame: at 12, 24, and 36 weeks after baseline ]
    Changes in 10-item Social Engagement and Activities Questionnaire score (score range: 0-50; increased score since baseline is a positive outcome)

  7. Changes from baseline satisfaction with social roles & activities at 12, 24, and 36 weeks [ Time Frame: at 12, 24, and 36 weeks after baseline ]
    C (score range: 0-32; increased score since baseline is a positive outcome)


Secondary Outcome Measures :
  1. Changes from baseline fear of falling at 12, 24, and 36 weeks [ Time Frame: at 12, 24, and 36 weeks after baseline ]
    Changes in 7-item Falls Efficacy Scale International score (score range: 7-28; decreased score since baseline is a positive outcome)

  2. Changes from baseline exercise frequency at 12, 24, and 36 weeks [ Time Frame: at 12, 24, and 36 weeks after baseline ]
    Changes in RAPA (Rapid Assessment of Physical Activities) (score range: 1-9; increased score since baseline is a positive outcome)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05011864


Contacts
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Contact: Namkee G Choi, PhD 5122329590 nchoi@austin.utexas.edu
Contact: Kelly Vences, BSW 5122320604 kelly.vences@utexas.edu

Locations
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United States, Texas
University of Texas at Austin Recruiting
Austin, Texas, United States, 78712-0358
Contact: Namkee G. Choi, PhD    512-232-9590    nchoi@mail.utexas.edu   
Principal Investigator: Namkee G. Choi, PhD         
Sponsors and Collaborators
University of Texas at Austin
Baylor College of Medicine
Investigators
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Principal Investigator: Namkee G Choi University of Texas at Austin
More Information
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Responsible Party: Namkee Choi, Professor and Louis and Ann Wolens Centennial Chair in Gerontology, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT05011864    
Other Study ID Numbers: 2R01MD009675-07 ( U.S. NIH Grant/Contract )
First Posted: August 18, 2021    Key Record Dates
Last Update Posted: February 16, 2023
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders