Acute Neurobehavioral Program for Improving Functional Status After TBI

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Virginia Commonwealth University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01166386
First received: July 19, 2010
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Traumatic Brain Injury
Behavioral: FANCI
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Acute Neurobehavioral Program for Improving Functional Status After TBI

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Functional Independence Measure scores [ Time Frame: Pre, post, six-month follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurobehavioral Rating Scale [ Time Frame: Pre, post, six month follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: March 2008
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166386

Contacts
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
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
Investigators
Principal Investigator: Janet P Niemeier, Ph.D. Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01166386     History of Changes
Other Study ID Numbers: 1RO1HD052922-01A2, 5R01HD052922, 1RO1HD052922-01A2
Study First Received: July 19, 2010
Last Updated: March 12, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
rehabilitation
brain injury

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 17, 2014