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

NCT05011864 | Recruiting DMC

• 1 other identifier: 2R01MD009675-07
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Unipolar; Fall

Outcome Measures

Primary Outcomes (7)

• Changes from baseline depressive symptom at 12, 24, and 36 weeks

  24-item Hamilton Rating Scale for Depression score (score range: 15-40; decreased score since baseline is a positive outcome)

  at 12, 24, and 36 weeks after baseline

• Changes from baseline fall count and injury at 12, 24, and 36 weeks

  Changes in six monthly falls calendar data (reduced number of falls since baseline is a positive outcome)

  monthly (form 12 weeks to 36 weeks)

• Changes from baseline EuroQol-5D score at 12, 24, and 36 weeks

  Cost-effectiveness measure (score range: 0-20; decreased score since baseline is a positive outcome)

  at 12, 24, and 36 weeks after baseline

• Changes from baseline physical and mental health service use

  Changes in Cornell Services index data (decreased ED visits and hospitalization since baseline is a positive outcome)

  at 12, 24, and 36 weeks after baseline

• Changes from baseline disability score at 12, 24, and 36 weeks

  Changes in 12-item World Health Organization Disability Assessment Schedule score (score range: 0-46; decreased score since baseline is a positive outcome)

  at 12, 24, and 36 weeks after baseline

• Changes from baseline social engagement and activities score at 12, 24, and 36 weeks

  Changes in 10-item Social Engagement and Activities Questionnaire score (score range: 0-50; increased score since baseline is a positive outcome)

  at 12, 24, and 36 weeks after baseline

• Changes from baseline satisfaction with social roles & activities at 12, 24, and 36 weeks

  C (score range: 0-32; increased score since baseline is a positive outcome)

  at 12, 24, and 36 weeks after baseline

Secondary Outcomes (2)

• Changes from baseline fear of falling at 12, 24, and 36 weeks

  at 12, 24, and 36 weeks after baseline

• Changes from baseline exercise frequency at 12, 24, and 36 weeks

  at 12, 24, and 36 weeks after baseline

Study Arms (4)

Tele-Behavioral Activation and Fall Prevention

EXPERIMENTAL

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; Behavioral: Fall Prevention

Tele-Behavioral Activation

EXPERIMENTAL

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

Fall Prevention

EXPERIMENTAL

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

Attention Control (Telephone Support Call)

ACTIVE COMPARATOR

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

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.

Also known as: Tele-BA

Tele-Behavioral Activation; Tele-Behavioral Activation and Fall Prevention

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.

Also known as: FP

Fall Prevention; Tele-Behavioral Activation and Fall Prevention

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.

Also known as: AC

Attention Control (Telephone Support Call)

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead
• Baylor College of Medicine: collaborator

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712-0358, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Namkee G Choi

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Namkee G Choi, PhD

CONTACT

5122329590; nchoi@austin.utexas.edu

Kelly Vences, BSW

CONTACT

5122320604; kelly.vences@utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Louis and Ann Wolens Centennial Chair in Gerontology

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 18, 2021
• Study Start: November 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)