- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01166386
Acute Neurobehavioral Program for Improving Functional Status After TBI
April 20, 2022 updated by: Wake Forest University Health Sciences
An Acute Neurobehavioral Program for Improving Functional Status After TBI
The specific aims of the proposed study are to 1) evaluate the efficacy of FANCI for improving functional status following treatment using the FIM, 2) examine the impact of FANCI on broader outcome measures of general emotional and behavioral functioning and productive activity in the community as measured post-treatment and at 6-month follow-up, 3) examine contributions of participant injury severity and cognitive status at time of treatment to treatment outcome and treatment response, 4) examine contributions of treatment variables of session topic and mastery, caregiver presence, and concurrent therapies on treatment outcome and treatment response for inpatients with TBI.
Primary outcome measure is the (FIM).
We will secondarily compare scores on the Disability Rating Scale (DRS), Glasgow Outcome Scale-Extended (GOSE), Rehabilitation Intensity of Therapy Scale (RITS), and Frontal Systems Behavior Scale (FRsBe).
Our design is a parallel groups, single-blind, randomized, controlled trial.
We will enroll 150 (75 treatment, 75 control) participants.
Inclusion Criteria: Mod to Sev TBI based on time to commands, English speaker, Length of stay ≥ 5 days in acute BI rehabilitation Unit, 18 years of age or older, ≥ 79 on GOAT.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
More than 1.7 million people a year in the United States begin confronting life with the medical, cognitive, and psychosocial challenges resulting from traumatic brain injury (TBI).
A range of cognitive impairments commonly observed following injury increase caregiver burden as well as per-person lifetime costs for care and support of survivors of TBI, estimated at $600,000 to $1,875,000.
Our long-term goal is to lessen these burdens through improving the functional status of patients with TBI by providing an evidence-based, comprehensive, brief, acute-care intervention, First Steps Acute Neurobehavioral and Cognitive Intervention (FANCI).
The 10-sesson, manualized FANCI Program will be tested in a controlled, randomized study.
Therapeutic components of the FANCI include didactics, cognitive remediation, demonstration, guided self-reflection, rehearsal, and supported practice of skills and strategies.
Specific hypotheses are that 1) FANCI will result in more improvement in functional status compared to standard interdisciplinary rehabilitation treatment and 2) FANCI will result in more improvement on measures of neurobehavioral functioning compared to standard rehabilitation care for patients with moderate to severe TBI.
We base these hypotheses on the observations that 1) providing information about symptoms, treatment, and coping results in reduced symptom intensity and duration for patients with TBI, and 2) inpatient participants in recent FANCI pilot studies learned >80% of the FANCI Program curriculum, and 3) the most recent pilot study participants had significantly better functional outcomes at discharge than matched controls.
The specific aims of the proposed study are to 1) evaluate the efficacy of FANCI for improving functional status following treatment using the FIM, 2) examine the impact of FANCI on broader outcome measures of general emotional and behavioral functioning and productive activity in the community as measured post-treatment and at 6-month follow-up, 3) examine contributions of participant injury severity and cognitive status at time of treatment to treatment outcome and treatment response, 4) examine contributions of treatment variables of session topic and mastery, caregiver presence, and concurrent therapies on treatment outcome and treatment response for inpatients with TBI.
Primary outcome measure is the (FIM).
We will secondarily compare scores on the Disability Rating Scale (DRS), Glasgow Outcome Scale-Extended (GOSE), Rehabilitation Intensity of Therapy Scale (RITS), and Frontal Systems Behavior Scale (FRsBe).
Our design is a parallel groups, single-blind, randomized, controlled trial.
We will enroll 150 (75 treatment, 75 control) participants.
Inclusion Criteria: Mod to Sev TBI based on time to commands, English speaker, Length of stay ≥ 5 days in acute BI rehabilitation Unit, 18 years of age or older, ≥ 79 on GOAT.
Study Type
Interventional
Enrollment (Actual)
165
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Charlotte, North Carolina, United States, 28203
- Carolinas Rehabilitation, Carolinas Medical Center, Department of Physical Medicine and Rehabilitation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria: at least 18 years old, English speaking, traumatic brain injury inpatient, out of post traumatic amnesia, not psychotic -
Exclusion Criteria: Prisoner, psychotic, not medically stable
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: First steps treatment intervention
A brief 10-session manualized acute neurobehavioral intervention program will be individually implemented with randomly assigned treatment participants.
Session components include injury-related education, enhancement of self-awareness of deficits from the TBI, coping and cognitive skills training, and supported practice.
The acronym "FANCI" refers to the name of the program which is First Steps Acute Neurobehavioral and Cognitive Intervention.
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comprehensive neurobehavioral sessions with therapist administrating treatment components
Other Names:
Watching DVDs chosen by participants on various topics.
Other Names:
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PLACEBO_COMPARATOR: standard rehabilitation care
The controls will spend 10 one-half hours with a therapist viewing videos they choose from a menu, some of which have to do with brain injury.
The therapist will interact naturally with the controls and occasionally relate the movie or film to brain injury rehabilitation.
|
comprehensive neurobehavioral sessions with therapist administrating treatment components
Other Names:
Watching DVDs chosen by participants on various topics.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Independence Measure Scores
Time Frame: Pre, at end of treatment up to one week, six-month follow up
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Minimum score = 18 Maximum possible with FIM = 126 directionality is toward the level of independence, lower numbers signify greater dependence on help from another person to complete the task or activity
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Pre, at end of treatment up to one week, six-month follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurobehavioral Rating Scale
Time Frame: Pre, post, six month follow up
|
The Neurobehavioral Rating Scale (NRS) is a provider or family rating scale for describing cognition, emotional, behavioral characteristics of a patient with brain injury.
Twenty-seven items assess symptoms such as Fatigueability, Depressive Mood, and Tension with 7-point rating scale including "not present," "Very mild," "Mild," "Moderate," "Mod-Severe," "Severe," and "Extremely Severe" to describe the person being rated.
Higher scores indicate worse severity of symptoms and lower score indicate an absence of the symptom or very mild symptomatology.
The minimum total score is 27 and the maximum total score is 189.
For each individual scale within the measures, the minimum score is 1 and the maximum score is 7.
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Pre, post, six month follow up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Janet P Niemeier, Ph.D., Carolinas Rehabilitation, Carolinas HealthCare System
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (ACTUAL)
January 1, 2014
Study Completion (ACTUAL)
January 1, 2014
Study Registration Dates
First Submitted
July 19, 2010
First Submitted That Met QC Criteria
July 19, 2010
First Posted (ESTIMATE)
July 21, 2010
Study Record Updates
Last Update Posted (ACTUAL)
April 22, 2022
Last Update Submitted That Met QC Criteria
April 20, 2022
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01HD052922-06 (NIH)
- 1R01HD052922-01A2 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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