Acute Neurobehavioral Program for Improving Functional Status After TBI

NCT01166386 | Completed Results DMC

• 2 other identifiers: 1R01HD052922-061R01HD052922-01A2
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

rehabilitation; brain injury

Outcome Measures

Primary Outcomes (1)

• Functional Independence Measure Scores

  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

  Pre, at end of treatment up to one week, six-month follow up

Secondary Outcomes (1)

• Neurobehavioral Rating Scale

  Pre, post, six month follow up

Study Arms (2)

First steps treatment intervention

EXPERIMENTAL

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

standard rehabilitation care

PLACEBO COMPARATOR

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

Interventions

FANCI BEHAVIORAL

comprehensive neurobehavioral sessions with therapist administrating treatment components

Also known as: First Steps Acute Neurobehavioral and Cognitive Intervention

First steps treatment intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

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

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

3 treatment subjects were discharged prior to completion of the treatment intervention. 5 controls were discharged prior to completion of the treatment intervention

Results Point of Contact

• Title: Dr. Janet Niemeier
• Organization: Carolinas Healthcare System, Carolinas Medical Center

janet.niemeier@carolinashealthcare.org

704 355 2046

Study Officials

• Janet P Niemeier, Ph.D.

  Carolinas Rehabilitation, Carolinas Healthcare System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: July 21, 2010
• Study Start: March 1, 2008
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: April 22, 2022
• Results First Posted: October 5, 2021

Record last verified: 2018-03

Locations

US (1)