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

July 19, 2010
March 12, 2012
March 2008
December 2012   (final data collection date for primary outcome measure)
Functional Independence Measure scores [ Time Frame: Pre, post, six-month follow up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01166386 on ClinicalTrials.gov Archive Site
Neurobehavioral Rating Scale [ Time Frame: Pre, post, six month follow up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Acute Neurobehavioral Program for Improving Functional Status After TBI
An Acute Neurobehavioral Program for Improving Functional Status After TBI

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Traumatic Brain Injury
  • Behavioral: FANCI
    compresensive neubehavioral sessions with therapist administrating treatment components
  • Behavioral: FANCI
    Watching DVDs chosen by participants on various topics.
  • Experimental: 1
    Treatment intervention using a 10-session behavioral program
    Intervention: Behavioral: FANCI
  • Placebo Comparator: 2
    Patients will spend time with a therapist viewing video discs and standard rehabilitation care
    Intervention: Behavioral: FANCI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
September 2013
December 2012   (final data collection date for primary outcome measure)

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

-

Both
18 Years to 80 Years
No
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
United States
 
NCT01166386
1RO1HD052922-01A2, 5R01HD052922, 1RO1HD052922-01A2
Yes
Virginia Commonwealth University
Virginia Commonwealth University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Janet P Niemeier, Ph.D. Virginia Commonwealth University
Virginia Commonwealth University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP