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Acute Neurobehavioral Program for Improving Functional Status After TBI

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ClinicalTrials.gov Identifier: NCT01166386
Recruitment Status : Unknown
Verified March 2012 by Virginia Commonwealth University.
Recruitment status was:  Recruiting
First Posted : July 21, 2010
Last Update Posted : March 13, 2012
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Description
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Brief Summary:
More than 1.4 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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Behavioral: FANCI Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Acute Neurobehavioral Program for Improving Functional Status After TBI
Study Start Date : March 2008
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : September 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Treatment intervention using a 10-session behavioral program
 Behavioral: FANCI
compresensive neubehavioral sessions with therapist administrating treatment components
Placebo Comparator: 2
Patients will spend time with a therapist viewing video discs and standard rehabilitation care
 Behavioral: FANCI
Watching DVDs chosen by participants on various topics.


Outcome Measures
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Primary Outcome Measures :
  1. Functional Independence Measure scores [ Time Frame: Pre, post, six-month follow up ]

Secondary Outcome Measures :
  1. Neurobehavioral Rating Scale [ Time Frame: Pre, post, six month follow up ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166386


Contacts
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Contact: Janet P Niemeier, Ph.d. 804.828.9867 jniemeier@mcvh-vcu.edu
Contact: Shy M Degrace, B.S. 804.827.2561 degracesm@vcu.edu

Locations
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United States, Virginia
Virginia Commonwealth University School of Medicine Recruiting
Richmond, Virginia, United States, 23298-0661
Contact: Janet P niemeier, ph.d.    804-828-9867    jniemeier@mcvh-vcu.edu   
Contact: William Walker, M.D.    804.828.0861    wwalker@mcvh-vcu.edu   
Sponsors and Collaborators
Virginia Commonwealth University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Janet P Niemeier, Ph.D. Virginia Commonwealth University
More Information
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01166386     History of Changes
Other Study ID Numbers: 1R01HD052922-01A2 ( U.S. NIH Grant/Contract )
5R01HD052922 ( U.S. NIH Grant/Contract )
1R01HD052922-01A2 ( U.S. NIH Grant/Contract )
First Posted: July 21, 2010    Key Record Dates
Last Update Posted: March 13, 2012
Last Verified: March 2012
Keywords provided by Virginia Commonwealth University:
rehabilitation
brain injury
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries