Acute Neurobehavioral Program for Improving Functional Status After TBI
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): FANCI; FANCI
Intervention type(s): Behavioral; Behavioral
Intervention description(s): comprehensive neurobehavioral sessions with therapist administrating treatment components; Watching DVDs chosen by participants on various topics.
Other intervention name(s): First Steps Acute Neurobehavioral and Cognitive Intervention; control condition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rehabilitation; brain injury