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Behavioural Intervention

Experimental for Traumatic Brain Injury

Phase < 1
Recruiting
Led By Daniel Klyce
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be adults (age 18 or older).
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at 24-weeks post-discharge
Awards & highlights

Study Summary

This trial focuses on helping patients with traumatic brain injury transition from inpatient rehabilitation to home or another level of care. These patients have various neurological impairments that affect their cognitive and behavioral abilities, as well

Who is the study for?
This trial is for individuals who have experienced a traumatic brain injury (TBI) and are transitioning from inpatient rehabilitation to home or another care setting. It aims to support patients, families, and healthcare providers during this change.Check my eligibility
What is being tested?
The study is examining the effectiveness of standard TBI rehab care compared with an experimental approach that includes community health services. The goal is to improve outcomes for those recovering from TBIs.See study design
What are the potential side effects?
Since this trial compares different approaches to rehabilitation rather than medications, it does not have typical drug side effects. However, there may be risks associated with changes in care practices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at 12- and 24-weeks post-discharge.
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 12- and 24-weeks post-discharge. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Managing Your loved Ones Health - Care Partner Activation
Secondary outcome measures
Caregiver Well-Being Scale - Short Form (CWBS-SF) - Care Partner Well-Bing
Patient Health Questionnaire - 4 (PHQ-4) - Care Partner Emotional Distress

Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard of CareExperimental Treatment1 Intervention
Transition Supports and Services (USS) that prepare care partners of persons with TBI for post-rehabilitation discharge
Group II: ExperimentalExperimental Treatment1 Intervention
USS supplemented with community health services delivered by a certified CHW (CHW+USS) for care partners

Find a Location

Who is running the clinical trial?

Department of Health and Human ServicesFED
226 Previous Clinical Trials
928,823 Total Patients Enrolled
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
71 Previous Clinical Trials
9,003 Total Patients Enrolled
Virginia Commonwealth UniversityLead Sponsor
699 Previous Clinical Trials
22,884,919 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for potential participants in this research study?

"Indeed, as stated on clinicaltrials.gov, this study is currently seeking eligible participants. The trial was initially published on January 31st, 2024 and underwent its most recent update on December 18th, 2023."

Answered by AI

How large is the patient cohort involved in this ongoing medical study?

"Indeed, the information available on clinicaltrials.gov indicates that this ongoing clinical trial is actively seeking eligible participants. The initial posting of the study took place on January 31st, 2024, and it was last updated on December 18th, 2023. This trial aims to enroll a total of 126 patients from a single designated location."

Answered by AI
~84 spots leftby Aug 2027