Acute Neurobehavioral Program for Improving Functional Status After TBI

• ClinicalTrials.gov Identifier: NCT01166386
• Recruitment Status: Completed
• First Posted: July 21, 2010
• Results First Posted: October 5, 2021
• Last Update Posted: April 22, 2022
• Sponsor: Wake Forest University Health Sciences
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Traumatic Brain Injury	Behavioral: FANCI	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 165 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
• Actual Primary Completion Date: January 2014
• Actual Study Completion Date: January 2014

Arms and Interventions

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.	Behavioral: FANCI; comprehensive neurobehavioral sessions with therapist administrating treatment components; Other Name: First Steps Acute Neurobehavioral and Cognitive Intervention
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.	Behavioral: FANCI; Watching DVDs chosen by participants on various topics.; Other Name: control condition

Outcome Measures

Primary Outcome Measures :

1. Functional Independence Measure Scores [ Time Frame: Pre, at end of treatment up to one week, six-month follow up ]
   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

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• 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

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Contacts and Locations

Locations

United States, North Carolina

Carolinas Rehabilitation, Carolinas Medical Center, Department of Physical Medicine and Rehabilitation

Charlotte, North Carolina, United States, 28203

Sponsors and Collaborators

Wake Forest University Health Sciences

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Principal Investigator: Janet P Niemeier, Ph.D.; Carolinas Rehabilitation, Carolinas Healthcare System

More Information

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT01166386
• Other Study ID Numbers: 1R01HD052922-06 ( U.S. NIH Grant/Contract ); 1R01HD052922-01A2 ( U.S. NIH Grant/Contract )
• First Posted: July 21, 2010
• Results First Posted: October 5, 2021
• Last Update Posted: April 22, 2022
• Last Verified: March 2018

Keywords provided by Wake Forest University Health Sciences:

rehabilitation; brain injury

Additional relevant MeSH terms:

Brain Injuries; Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries