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NCT03739450 · ClinicalTrials.gov registry record · NA
Problem Solving Training for Care Partners of Adults With Traumatic Brain Injury
A NA study of Care Partners of Patients With Traumatic Brain Injury (TBI), sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 94
- Enrollment target
- 4
- Study locations
NCT03739450: Completed NA study of Care Partners of Patients With Traumatic Brain Injury (TBI), sponsored by University of Texas Southwestern Medical Center.
NCT03739450 is a NA study of Care Partners of Patients With Traumatic Brain Injury (TBI) that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 94 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03739450, a NA study of Care Partners of Patients With Traumatic Brain Injury (TBI), has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 94 participants
- Enrollment target
- 4
- Study locations
Study Summary
Importance: The chronic consequences of TBI are established, but ongoing support for adults with TBI living in the community is limited. This puts undue burden on care partners, particularly during the transition from hospital to home. It often leads to adverse consequences among care partners, such as emotional distress and increased substance abuse. Currently, there are no evidence-based interventions for care partners of adults with TBI to prepare them for this role. Problem Solving Training (PST) is an evidence-based, self-management approach with demonstrated efficacy for care partners of individuals with disabilities, but it has not been delivered or evaluated during inpatient rehabilitation. Aims: Aim 1): To assess the feasibility of providing PST to care partners of adults with TBI during the inpatient rehabilitation stay; Aim 2) To assess the efficacy of PST + education vs education alone for improving caregiver burden, depressive symptoms, and coping skills Method: The investigators will conduct a randomized control trial of PST + Education vs Education alone during the inpatient rehabilitation stay of individuals with TBI. The investigators will enroll 172 care partners and conduct baseline assessment, with follow-up assessment at 1 month and 6 months post-discharge. For Aim 1, the investigators will measure number of sessions of PST completed and care partner satisfaction. For Aim 2, the investigators will compare differences in PST+Educaion vs. Education alone in measures of caregiver burden, depressive symptoms, and coping skills at 1-month and 6-months post-discharge. Conclusion: The investigators anticipate that care partners will be able to complete a minimum of 3 sessions during the inpatient rehabilitation stay and that PST + Education will be more effective than Education alone for reducing caregiver burden and depressive symptoms and improving positive coping among care partners. PST is an evidence-based, self-management approach with a strong
Primary Outcome
The PHQ-9 assesses the frequency over the past two weeks of each of the nine symptoms of DSM-IV-TR that define a major depressive episode. Total scores range from 0-27, with established interpretative symptom cut-off scores of 0-4 (none), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), and \>20 (severe).(positive = improvement)
Conditions Studied
Interventions
- BEHAVIORAL Education
- BEHAVIORAL Problem Solving Training (PST)
Study Locations (4)
New Jersey
- Kessler Foundation - East Hanover
- JFK Johnson Rehabilitation Institute - Edison
Texas
- Baylor Scott & White Institute for Rehabilitation - Dallas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2018-11-20 |
| Est. Completion | 2022-10-22 |
| Phase | NA |
What the finished NCT03739450 record still lists
NCT03739450 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Care Partners of Patients With Traumatic Brain Injury (TBI) appearing as the primary indexed condition, and to 2 interventions - of which Education is the first listed.
NCT03739450 reports a single indexed study location in New Jersey, Texas.
Frequently Asked Questions
What is clinical trial NCT03739450 about?
NCT03739450 is a clinical study titled "Problem Solving Training for Care Partners of Adults With Traumatic Brain Injury". Importance: The chronic consequences of TBI are established, but ongoing support for adults with TBI living in the community is limited. This puts undue burden on care partners, particularly during the transition from hospital to home. It often leads to adverse consequences among care partners, such...
What is the current status of trial NCT03739450?
This trial is currently completed. It is a NA study. The enrollment target is 94 participants. The study started on 2018-11-20. Estimated completion is 2022-10-22.
What conditions does trial NCT03739450 study?
This clinical trial studies the following conditions: Care Partners of Patients With Traumatic Brain Injury (TBI).
What interventions are being tested in trial NCT03739450?
The interventions under investigation include: Education (BEHAVIORAL), Problem Solving Training (PST) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03739450?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03739450 being conducted?
This trial has 4 study locations across New Jersey, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03739450's enrollment target sits among peer trials
94 935th of 2000 higher than 1,064 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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