Acute Neurobehavioral Program for Improving Functional Status After TBI

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01166386
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 165
• Location: 1
• Arms: 2
• Duration (Months): 70
• Patients Per Site Per Month: 2.4

Study Details

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; Behavioral: FANCI	N/A

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
• 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: Mar 1, 2008
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 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 Names: 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 Names: control condition

Outcome Measures

Primary Outcome Measures

1. Functional Independence Measure Scores [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT01166386
• Other Study ID Numbers: 1R01HD052922-06; 1R01HD052922-01A2
• First Posted: Jul 21, 2010
• Last Update Posted: Apr 22, 2022
• Last Verified: Mar 1, 2018

• Keywords provided by Wake Forest University Health Sciences: rehabilitation; brain injury
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic

Study Results

Participant Flow

Arm/Group Title	First Steps Treatment Intervention	Standard Rehabilitation Care
Arm/Group Description	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. FANCI: comprehensive neurobehavioral sessions with therapist administrating treatment components	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. FANCI: Watching DVDs chosen by participants on various topics.
Period Title: Overall Study
STARTED	82	83
COMPLETED	79	78
NOT COMPLETED	3	5

Baseline Characteristics

Arm/Group Title	First Steps Treatment Intervention	Standard Rehabilitation Care	Total
Arm/Group Description	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. FANCI: comprehensive neurobehavioral sessions with therapist administrating treatment components	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. FANCI: Watching DVDs chosen by participants on various topics.	Total of all reporting groups
Overall Participants	82	83	165
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.62 (16.75)	42.21 (18.95)	41.07 (18.13)
Sex: Female, Male (Count of Participants)
Female	23 28%	25 30.1%	48 29.1%
Male	59 72%	58 69.9%	117 70.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 3.7%	1 1.2%	4 2.4%
Not Hispanic or Latino	79 96.3%	79 95.2%	158 95.8%
Unknown or Not Reported	0 0%	3 3.6%	3 1.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 3.7%	1 1.2%	4 2.4%
Asian	1 1.2%	1 1.2%	2 1.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	24 29.3%	21 25.3%	45 27.3%
White	52 63.4%	57 68.7%	109 66.1%
More than one race	1 1.2%	0 0%	1 0.6%
Unknown or Not Reported	1 1.2%	3 3.6%	4 2.4%
Region of Enrollment (participants) [Number]
United States	82 100%	83 100%	165 100%

Outcome Measures

1. Primary Outcome

Title	Functional Independence Measure Scores
Description	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
Time Frame	Pre, at end of treatment up to one week, six-month follow up

Outcome Measure Data

Analysis Population Description

Several persons terminated the intervention project, some files did not get transferred from one of the PIs institutions to another when she changed jobs.

Arm/Group Title	First Steps Treatment Intervention	Standard Rehabilitation Care
Arm/Group Description	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. FANCI: comprehensive neurobehavioral sessions with therapist administrating treatment components	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. FANCI: Watching DVDs chosen by participants on various topics.
Measure Participants	73	70
baseline	88.11 (10.26)	89.79 (12.29)
at end of treatment up to one week	120.57 (7.32)	119.67 (8.03)
six month follow-up	48.98 (16.65)	50.93 (14.86)

2. Secondary Outcome

Title	Neurobehavioral Rating Scale
Description	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.
Time Frame	Pre, post, six month follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	First Steps Treatment Intervention	Standard Rehabilitation Care
Arm/Group Description	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. FANCI: comprehensive neurobehavioral sessions with therapist administrating treatment components	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. FANCI: Watching DVDs chosen by participants on various topics.
Measure Participants	73	69
baseline	56.23 (12.83)	58.70 (13.60)
post-treatment	48.4857 (9.94003)	50.2985 (10.51264)
follow-up	48.9778 (16.64808)	50.9318 (14.85495)

Adverse Events

Arm/Group Title	First Steps Treatment Intervention		Standard Rehabilitation Care
Arm/Group Description	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. FANCI: comprehensive neurobehavioral sessions with therapist administrating treatment components		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. FANCI: Watching DVDs chosen by participants on various topics.
All Cause Mortality
	First Steps Treatment Intervention		Standard Rehabilitation Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	First Steps Treatment Intervention		Standard Rehabilitation Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/82 (1.2%)		0/83 (0%)
Nervous system disorders
stroke	1/82 (1.2%)		0/83 (0%)
Other (Not Including Serious) Adverse Events
	First Steps Treatment Intervention		Standard Rehabilitation Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/82 (0%)		0/83 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.