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

Primary Purpose

Depression, Unipolar, Fall

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation
Fall Prevention
Telephone support
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Unipolar

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas at AustinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Tele-Behavioral Activation and Fall Prevention

Tele-Behavioral Activation

Fall Prevention

Attention Control (Telephone Support Call)

Arm Description

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

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.

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.

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.

Outcomes

Primary Outcome Measures

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)
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)
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)
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)
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)
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)
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)

Secondary Outcome Measures

Changes from baseline fear of falling at 12, 24, and 36 weeks
Changes in 7-item Falls Efficacy Scale International score (score range: 7-28; decreased score since baseline is a positive outcome)
Changes from baseline exercise frequency at 12, 24, and 36 weeks
Changes in RAPA (Rapid Assessment of Physical Activities) (score range: 1-9; increased score since baseline is a positive outcome)

Full Information

First Posted
August 6, 2021
Last Updated
February 15, 2023
Sponsor
University of Texas at Austin
Collaborators
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05011864
Brief Title
Integrated Tele-Behavioral Activation and Fall Prevention for Low-income Homebound Seniors With Depression
Acronym
TBF
Official Title
Integrated Tele-Behavioral Activation and Fall Prevention for Low-income Homebound Older Adults With Depression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
Collaborators
Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Unipolar, Fall

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tele-Behavioral Activation and Fall Prevention
Arm Type
Experimental
Arm Description
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
Arm Title
Tele-Behavioral Activation
Arm Type
Experimental
Arm Description
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.
Arm Title
Fall Prevention
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control (Telephone Support Call)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation
Other Intervention Name(s)
Tele-BA
Intervention Description
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
Intervention Name(s)
Fall Prevention
Other Intervention Name(s)
FP
Intervention Description
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
Other
Intervention Name(s)
Telephone support
Other Intervention Name(s)
AC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes from baseline depressive symptom at 12, 24, and 36 weeks
Description
24-item Hamilton Rating Scale for Depression score (score range: 15-40; decreased score since baseline is a positive outcome)
Time Frame
at 12, 24, and 36 weeks after baseline
Title
Changes from baseline fall count and injury at 12, 24, and 36 weeks
Description
Changes in six monthly falls calendar data (reduced number of falls since baseline is a positive outcome)
Time Frame
monthly (form 12 weeks to 36 weeks)
Title
Changes from baseline EuroQol-5D score at 12, 24, and 36 weeks
Description
Cost-effectiveness measure (score range: 0-20; decreased score since baseline is a positive outcome)
Time Frame
at 12, 24, and 36 weeks after baseline
Title
Changes from baseline physical and mental health service use
Description
Changes in Cornell Services index data (decreased ED visits and hospitalization since baseline is a positive outcome)
Time Frame
at 12, 24, and 36 weeks after baseline
Title
Changes from baseline disability score at 12, 24, and 36 weeks
Description
Changes in 12-item World Health Organization Disability Assessment Schedule score (score range: 0-46; decreased score since baseline is a positive outcome)
Time Frame
at 12, 24, and 36 weeks after baseline
Title
Changes from baseline social engagement and activities score at 12, 24, and 36 weeks
Description
Changes in 10-item Social Engagement and Activities Questionnaire score (score range: 0-50; increased score since baseline is a positive outcome)
Time Frame
at 12, 24, and 36 weeks after baseline
Title
Changes from baseline satisfaction with social roles & activities at 12, 24, and 36 weeks
Description
C (score range: 0-32; increased score since baseline is a positive outcome)
Time Frame
at 12, 24, and 36 weeks after baseline
Secondary Outcome Measure Information:
Title
Changes from baseline fear of falling at 12, 24, and 36 weeks
Description
Changes in 7-item Falls Efficacy Scale International score (score range: 7-28; decreased score since baseline is a positive outcome)
Time Frame
at 12, 24, and 36 weeks after baseline
Title
Changes from baseline exercise frequency at 12, 24, and 36 weeks
Description
Changes in RAPA (Rapid Assessment of Physical Activities) (score range: 1-9; increased score since baseline is a positive outcome)
Time Frame
at 12, 24, and 36 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Namkee G Choi, PhD
Phone
5122329590
Email
nchoi@austin.utexas.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Vences, BSW
Phone
5122320604
Email
kelly.vences@utexas.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Namkee G Choi
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712-0358
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Namkee G. Choi, PhD
Phone
512-232-9590
Email
nchoi@mail.utexas.edu
First Name & Middle Initial & Last Name & Degree
Namkee G. Choi, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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