Community Health Services for Traumatic Brain Injury
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Virginia Commonwealth University
Disqualifiers: Severe cognitive impairment
No Placebo Group
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.
12345Is 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.
23456How 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.
12478Eligibility 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.
+2 more
Exclusion Criteria
I do not have severe cognitive issues that prevent me from making decisions or caring for someone.
Trial 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
Participant Groups
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.
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
Virginia Commonwealth UniversityRichmond, VA
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Who Is Running the Clinical Trial?
Virginia Commonwealth UniversityLead Sponsor
Department of Health and Human ServicesCollaborator
National Institute on Disability, Independent Living, and Rehabilitation ResearchCollaborator
References
The contributions of disease activity, sleep patterns, and depression to fatigue in systemic lupus erythematosus. A proposed model. [2019]This study describes lupus fatigue multidimensionally and introduces a multivariate model: Sleep problems and depression, through reciprocal effects on each other, act as mediators through which lupus disease activity increases fatigue.
Disease status predicts fatigue in systemic lupus erythematosus. [2006]To investigate the relative contributions of disease status, helplessness, and depression to fatigue in patients with systemic lupus erythematosus (SLE) in a path-analytic framework.
Disease activity and damage are not associated with increased levels of fatigue in systemic lupus erythematosus patients from a multiethnic cohort: LXVII. [2022]To determine the factors associated with increased levels of fatigue over the course of the disease in systemic lupus erythematosus (SLE) patients from LUpus in MInorities: NAture versus nurture, a longitudinal multiethnic cohort.
Motivational interviewing intervention for increasing physical activity and improving dietary behaviors: The Lupus Intervention Fatigue Trial protocol. [2023]The Lupus Intervention Fatigue Trial (LIFT) is a prospective, randomized controlled trial to assess the effectiveness of a six-month motivational interviewing intervention program versus an educational control to reduce fatigue in persons with systematic lupus erythematosus (SLE). Participants are randomized using a stratified, 1:1 allocation design to the LIFT intervention or control arm. We plan to enroll 236 participants to achieve the target of 200 persons with six-month follow-up for the primary endpoint. Specific aims of this study are to evaluate the impact of the LIFT intervention on 1) self-reported measures of fatigue and 2) impact on accelerometer-measured physical activity. The primary study outcome is six-month change in fatigue from baseline, assessed by the Fatigue Severity Score (FSS). Additional outcomes include objective measures of physical activity, including non-sedentary behavior and moderate-to-vigorous activity (secondary outcome), and adherence to the LIFT dietary intervention, as assessed by nutrient density (diet quality) and recommended food groups/eating patterns (exploratory outcome) in persons with SLE. Intervention effectiveness will be assessed using an intention-to-treat two-arm comparison of six-month change in FSS, with one interim monitoring analysis. A two-sample independent group t-test will compare the six-month changes in FSS between the study arms. Intervention effect durability will be assessed 12-months after baseline (6 months after completion of the intervention). Enrollment began in June 2019 and is expected to end in June 2023. This study will inform future intervention strategies that promote physical activity and improved diet quality to reduce fatigue in persons with SLE.
Dimensions of fatigue in systemic lupus erythematosus: relationship to disease status and behavioral and psychosocial factors. [2022]To characterize the experience of fatigue in patients with systemic lupus erythematosus (SLE) using a multidimensional assessment and to delineate contributors to physical and mental dimensions of fatigue.
Improvement of coping abilities in patients with systemic lupus erythematosus: a prospective study. [2019]To evaluate a novel specific psychological intervention aimed at improving coping in patients with systemic lupus erythematosus (SLE).
Psychometric Analysis from EMBODY1 and 2 Clinical Trials to Help Select Suitable Fatigue PRO Scales for Future Systemic Lupus Erythematosus Studies. [2023]Fatigue is one of the most important symptoms reported by patients with systemic lupus erythematosus (SLE) and a key concept of interest in SLE clinical trials. Despite this, fatigue remains poorly understood and sub-optimally measured by existing patient-reported outcome (PRO) instruments and scales. Here, we psychometrically evaluated the measurement properties of three PRO scales that purport to measure fatigue, using data from two SLE clinical trials.
Measurement of fatigue in systemic lupus erythematosus: a systematic review. [2022]To systematically review fatigue instruments used in patients with systemic lupus erythematosus (SLE) and to seek consensus on which instruments should be recommended for future studies and which data on comorbid conditions should be reported when evaluating fatigue in patients with SLE.