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

Trial Summary

What is the purpose of this trial?

TBI rehabilitation care transitions refer to the processes of preparing patients, families, and community-based healthcare providers for the patient's passage from inpatient rehabilitation to the home and community or to another level of care. Persons with TBI have heterogenous neurological impairment (cognitive and behavioral foremost, along with motor, sensory, and balance), that limits their functional independence and participation, and increases their risk for secondary medical conditions, injuries, rehospitalizations and early mortality

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 data supports the effectiveness of the treatment Motivational Interviewing Program for Fatigue Management in the clinical trial Community Health Services for Traumatic Brain Injury?

The Motivational Interviewing Program for Fatigue Management, as part of the Lupus Intervention Fatigue Trial (LIFT), has shown potential in reducing fatigue and increasing physical activity in people with systemic lupus erythematosus (SLE). This suggests it might help manage fatigue in other conditions, like traumatic brain injury, by promoting healthier lifestyle changes. ^{1 2 3 4 5}

Is the Motivational Interviewing Program for Fatigue Management safe for humans?

The Motivational Interviewing Program for Fatigue Management, evaluated in the Lupus Intervention Fatigue Trial (LIFT), is a behavioral intervention aimed at reducing fatigue and improving physical activity and diet in people with lupus. While the study focuses on effectiveness, motivational interviewing is generally considered safe as it involves counseling techniques rather than medical procedures or drugs. ^{2 3 4 5 6}

How does the Community Health Services for Traumatic Brain Injury treatment differ from other treatments?

This treatment is unique because it incorporates a motivational interviewing program to manage fatigue, which is typically used in lupus patients to improve physical activity and dietary behaviors. This approach is novel for traumatic brain injury as it focuses on lifestyle changes rather than traditional medical interventions. ^{1 2 4 7 8}

Research Team

Daniel Klyce

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

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

I am 18 years old or older.

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.

Exclusion Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The contributions of disease activity, sleep patterns, and depression to fatigue in systemic lupus erythematosus. A proposed model. [2019]

2. Canada pubmed.ncbi.nlm.nih.gov

Disease status predicts fatigue in systemic lupus erythematosus. [2006]

3. United States 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Motivational interviewing intervention for increasing physical activity and improving dietary behaviors: The Lupus Intervention Fatigue Trial protocol. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

Dimensions of fatigue in systemic lupus erythematosus: relationship to disease status and behavioral and psychosocial factors. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Improvement of coping abilities in patients with systemic lupus erythematosus: a prospective study. [2019]

7. England 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

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