Ignite Creation Date:
2024-05-06 @ 4:32 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05011864
Status:
RECRUITING
Last Update Posted:
2024-01-09
First Post:
2021-08-06
Brief Title:
Integrated Tele-Behavioral Activation and Fall Prevention for Low-income Homebound Seniors With Depression
Sponsor:
University of Texas at Austin
Organization:
University of Texas at Austin
Study Overview
Official Title:
Integrated Tele-Behavioral Activation and Fall Prevention for Low-income Homebound Older Adults With Depression
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TBF
Brief Summary:
This study will test clinical and cost effectiveness of an integrated tele- and bachelors-level counselorcoach 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 bachelors-level lay counselorscoaches 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 counselorscoaches and our recent clinical trial 1R01MD009675 and a FP pilot study show that lay counselorscoaches 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 counselorscoaches 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 20 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None