Community Health Services for Traumatic Brain Injury

Overseen By Ronald Seel

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Virginia Commonwealth University

Disqualifiers: Severe cognitive impairment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

126 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care transitions for individuals with traumatic brain injuries (TBI) as they move from hospital rehab to home. It compares two approaches: standard care and an enhanced approach that includes community health services provided by a certified health worker. The focus is on helping patients and their caregivers manage better at home and avoid issues like rehospitalizations. Caregivers involved in the daily care of someone with TBI and comfortable with smartphone communication may be a good fit. As an Early Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants a chance to contribute to groundbreaking insights.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe for TBI rehabilitation care transitions?

Research shows that the treatment being tested in this trial—community health services for traumatic brain injury (TBI)—has not yet been specifically studied for safety in humans. This trial is in an early stage, so researchers are still learning about the treatment's safety. Early-stage trials usually focus on how well people tolerate a new treatment and identify any possible side effects.

Early-stage trials might have more unknowns compared to later ones. However, involving certified community health workers (CHWs) emphasizes personalized care, which often aims to ensure safety and effectiveness.

Prospective participants should discuss with trial coordinators and healthcare providers to understand the risks and benefits based on individual health needs and conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how adding community health services delivered by a certified Community Health Worker (CHW) can enhance care for individuals with Traumatic Brain Injury (TBI) after they've been discharged from rehabilitation. Unlike the standard approach, which mainly involves Transition Supports and Services (USS) to prepare care partners for post-rehabilitation, this experimental method supplements USS with personalized community health interventions. These interventions aim to provide ongoing support and guidance, potentially improving long-term outcomes and quality of life for both patients and their caregivers.

What evidence suggests that this trial's treatments could be effective for TBI rehabilitation?

Research has shown that community health services can greatly assist patients with traumatic brain injury (TBI) as they transition from the hospital to their homes. In this trial, one group will receive the experimental treatment, which includes USS supplemented with community health services delivered by a certified community health worker (CHW+USS) for care partners. This support often involves trained community health workers who help organize care and offer assistance. These services have increased patient satisfaction and reduced the likelihood of hospital readmission. Although specific data on this exact approach for TBI is limited, similar programs for other conditions have successfully improved patient outcomes. The aim is to help patients become more independent and enhance their quality of life. ^{1 2 3 4 5}

Who Is on the Research Team?

Daniel Klyce

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Must be primary person responsible for supervision/care needs of person with TBI post-IRF discharge.

The person with TBI must have been admitted to the Brain Injury Service Unit at SAI.

If the care partner does not live in the same residence as the person with TBI, they must provide multiple daily check-ins on day-to-day care.

Exclusion Criteria

I do not have severe cognitive issues that prevent me from making decisions or caring for someone.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care transition supports and services (USS) or USS supplemented with community health services delivered by a certified CHW

12 weeks

Regular interactions with community health workers

Follow-up

Participants are monitored for emotional distress, care partner activation, and well-being post-discharge

24 weeks

Assessments at 12 and 24 weeks post-discharge

What Are the Treatments Tested in This Trial?

Interventions

• Experimental
• Standard of Care

Trial Overview 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.

How Is the Trial Designed?

Group I: Standard of Care Experimental Treatment 1 Intervention

Transition Supports and Services (USS) that prepare care partners of persons with TBI for post-rehabilitation discharge

Group II: Experimental Experimental Treatment 1 Intervention

USS supplemented with community health services delivered by a certified CHW (CHW+USS) for care partners

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Published Research Related to This Trial

The study evaluated the measurement properties of three fatigue scales (FACIT-F, SF-36 Vitality, and LupusQoL Fatigue) using data from two phase 3 clinical trials involving systemic lupus erythematosus (SLE) patients, revealing that while FACIT-F had good reliability (0.93), the other scales showed significant limitations, particularly SF-36 Vitality with a low reliability of 0.53.

Pooled fatigue items from the scales improved psychometric properties and were more sensitive in detecting changes in fatigue over time, indicating a need for further research to enhance fatigue measurement tools for better application in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric Analysis from EMBODY1 and 2 Clinical Trials to Help Select Suitable Fatigue PRO Scales for Future Systemic Lupus Erythematosus Studies. Cleanthous, S., Bongardt, S., Marquis, P., et al.[2023]

A novel psychological intervention for 34 patients with systemic lupus erythematosus (SLE) led to significant improvements in coping skills, depression, and anxiety over a six-month period, as measured by validated psychological instruments.

The intervention, which included psychoeducational and psychotherapeutic elements, resulted in sustained benefits in quality of life, while a waiting list group showed no significant changes, highlighting the efficacy of the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of coping abilities in patients with systemic lupus erythematosus: a prospective study. Haupt, M., Millen, S., Jänner, M., et al.[2019]

In a study of 130 women with systemic lupus erythematosus (SLE), fatigue was found to be multidimensional, with general and physical fatigue being the most pronounced, influenced by factors like disease activity, damage, and depressed mood.

Depressed mood was identified as the strongest contributor to mental fatigue, while physical fatigue was linked to disease-related factors and lifestyle aspects, highlighting the need for tailored interventions to address both dimensions of fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dimensions of fatigue in systemic lupus erythematosus: relationship to disease status and behavioral and psychosocial factors. Da Costa, D., Dritsa, M., Bernatsky, S., et al.[2022]

The 9-item Fatigue Severity Scale (FSS) is recommended for evaluating fatigue in patients with systemic lupus erythematosus (SLE), as it was the most commonly used instrument in the reviewed studies and showed significant correlations with fatigue-related factors.

Fatigue in SLE patients is closely linked to other issues like pain, poor sleep quality, and depression, highlighting the need to report these comorbid conditions in future studies to better understand and address fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement of fatigue in systemic lupus erythematosus: a systematic review. [2022]

In a study of 81 patients with systemic lupus erythematosus (SLE), disease status was found to be a direct predictor of fatigue, indicating that managing the underlying disease may help reduce fatigue levels.

Helplessness and depression were identified as mediating factors between disease status and fatigue, but over time, disease status remained the sole predictor of fatigue, highlighting the importance of addressing the disease itself for effective fatigue management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disease status predicts fatigue in systemic lupus erythematosus. Tayer, WG., Nicassio, PM., Weisman, MH., et al.[2006]

In a study of 515 systemic lupus erythematosus (SLE) patients, factors such as Caucasian ethnicity, pain levels, abnormal illness-related behaviors, and feelings of helplessness were linked to increased fatigue, highlighting the importance of psychological and social factors in managing fatigue.

Interestingly, traditional SLE-specific measures like disease activity and damage did not correlate with fatigue levels, suggesting that interventions to reduce fatigue should focus on addressing pain and psychological well-being rather than just disease severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disease activity and damage are not associated with increased levels of fatigue in systemic lupus erythematosus patients from a multiethnic cohort: LXVII. Burgos, PI., Alarcón, GS., McGwin, G., et al.[2022]

The Lupus Intervention Fatigue Trial (LIFT) is a randomized controlled trial involving 236 participants aimed at reducing fatigue in individuals with systemic lupus erythematosus (SLE) through a six-month motivational interviewing program compared to an educational control.

The primary outcome of the study is the change in fatigue levels measured by the Fatigue Severity Score after six months, with additional assessments of physical activity and dietary adherence, which will help develop future strategies for managing fatigue in SLE patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing intervention for increasing physical activity and improving dietary behaviors: The Lupus Intervention Fatigue Trial protocol. Kinnett-Hopkins, D., Ehrlich-Jones, L., Chmiel, JS., et al.[2023]

Women with systemic lupus erythematosus (SLE) experience significantly greater fatigue compared to women from the general population, with sleep problems and depression playing key roles in this fatigue.

The study supports a model where sleep issues and depression mediate the relationship between lupus disease activity and fatigue, suggesting that effective treatment should target these factors alongside managing disease activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The contributions of disease activity, sleep patterns, and depression to fatigue in systemic lupus erythematosus. A proposed model. McKinley, PS., Ouellette, SC., Winkel, GH.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35091136/

The Lupus Intervention Fatigue Trial protocol - PubMed - NIH The Lupus Intervention Fatigue Trial (LIFT) is a prospective, randomized controlled trial to assess the effectiveness of a six-month motivational interviewing ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02653287

NCT02653287 | Lupus Intervention for Fatigue Trial This study is designed to evaluate the LIFT intervention to decrease fatigue (primary outcome), improve physical activity (secondary outcome) and dietary ...

3. reporter.nih.gov reporter.nih.gov/search/N8cfm_apNUGTAwExKNvc7g/project-details/9748431

Lupus Intervention Fatigue Trial (LIFT) LIFT is a 12-month phase III randomized, parallel group, single blind 2-arm trial designed to compare the effectiveness of a motivational interviewing program ...

4. acrabstracts.org acrabstracts.org/abstract/lupus-intervention-fatigue-trial-preliminary-analysis-of-baseline-data/

Lupus Intervention Fatigue Trial: Preliminary Analysis of ... The Lupus Intervention Fatigue Trial, LIFT (NCT02653287), a 12-month, phase II randomized, parallel-group, single-blind study compared motivational interviewing ...

5. trials.arthritis.org trials.arthritis.org/trials/NCT02653287

Lupus Intervention for Fatigue Trial - Arthritis Foundation This study is designed to evaluate the LIFT intervention to decrease fatigue (primary outcome), improve physical activity (secondary outcome) and dietary ...