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NCT05307640 · ClinicalTrials.gov registry record · NA
Caregiver Wellness After Traumatic Brain Injury (CG-WELL): An Intervention Designed to Promote Well-being in Caregivers of Acute Moderate to Severe Traumatic Brain Injuries
A NA study of Trauma, Brain, sponsored by Natalie Kreitzer.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05307640: Recruiting NA study of Trauma, Brain, sponsored by Natalie Kreitzer.
NCT05307640 is a NA study of Trauma, Brain that is actively recruiting participants, run by Natalie Kreitzer. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05307640, a NA study of Trauma, Brain, is actively recruiting participants, sponsored by Natalie Kreitzer.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
After injury, survivors of msTBI depend on informal family caregivers. Upwards of 77% of family caregivers experience poor outcomes, such as adverse life changes, poor health related quality of life, and increased depressive symptoms. Caregivers frequently report minimal support or training to prepare them for their new role. Periods of care transitions, such as ICU discharge, are most difficult. The majority (93%) of previously developed caregiver and caregiver/survivor dyad interventions after msTBI focus on providing information or practical skills to either survivors, or to long-term caregivers (\>6 months post injury), rather than education, support, and skill-building that the new caregiver may use proactively that will benefit the dyad acutely after injury. The Aims of this proposal are to: (1) Determine feasibility, satisfaction, and data trends of CG-Well; and (2) Understand how baseline psychosocial risk factors affect response to CG-Well compared to an Information, Support, and Referral control group. To accomplish this, I will first enroll 6-10 caregivers and tailor CG-well until each finds the intervention acceptable, appropriate, and feasible. I will then enroll 100 (50/group) dyads and determine satisfaction ratings, recruitment, retention, and treatment fidelity of CG-Well. Additionally, I will determine if caregivers report reductions in depressive symptoms and improvements in life changes as a result of improvements in task difficulty and threat appraisal in CG-Well compared to ISR at six months. Information obtained in Aims 1 and 2 will be used to plan a larger Phase III trial of CG-Well. Completing these Aims and the training plan will improve outcomes of caregivers and downstream outcomes of survivors of msTBI, and provide me with the skillset necessary to become an independent researcher who can develop and test high-impact, high-fidelity, sustainable interventions.
Primary Outcome
Scale Title: Caregiver Intervention Satisfaction Scale. Likert's scale of usability, ease of use, and acceptability of INR or CG-Well A higher score indicates greater satisfaction; 1-5 scale (strongly disagree=1; strongly agree=5)
Conditions Studied
Interventions
- BEHAVIORAL CG-Well
- BEHAVIORAL Information Support & Referral (ISR)
Study Locations (1)
Ohio
- University of Cincinnati - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-08-16 |
| Est. Completion | 2025-10-01 |
| Phase | NA |
What NCT05307640 shows while recruiting
NCT05307640 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, 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 Trauma, Brain appearing as the primary indexed condition, and to 2 interventions - of which CG-Well is the first listed.
NCT05307640 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05307640 about?
NCT05307640 is a clinical study titled "Caregiver Wellness After Traumatic Brain Injury (CG-WELL): An Intervention Designed to Promote Well-being in Caregivers of Acute Moderate to Severe Traumatic Brain Injuries". After injury, survivors of msTBI depend on informal family caregivers. Upwards of 77% of family caregivers experience poor outcomes, such as adverse life changes, poor health related quality of life, and increased depressive symptoms. Caregivers frequently report minimal support or training to prepa...
What is the current status of trial NCT05307640?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2021-08-16. Estimated completion is 2025-10-01.
What conditions does trial NCT05307640 study?
This clinical trial studies the following conditions: Trauma, Brain.
What interventions are being tested in trial NCT05307640?
The interventions under investigation include: CG-Well (BEHAVIORAL), Information Support & Referral (ISR) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05307640?
This trial is sponsored by Natalie Kreitzer, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05307640 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05307640's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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