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Behavioural Intervention

Community Health Services 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
Must not have
Any severe cognitive impairment that precludes the ability to provide informed consent or safely function as the care partner for a vulnerable adult with TBI.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at 24-weeks post-discharge
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have severe cognitive issues that prevent me from making decisions or caring for someone.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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?

Virginia Commonwealth UniversityLead Sponsor
714 Previous Clinical Trials
22,888,269 Total Patients Enrolled
Department of Health and Human ServicesFED
231 Previous Clinical Trials
935,423 Total Patients Enrolled
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
79 Previous Clinical Trials
9,721 Total Patients Enrolled
~84 spots leftby Aug 2027
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