Trial Outcomes & Findings for Acute Neurobehavioral Program for Improving Functional Status After TBI (NCT NCT01166386)
NCT ID: NCT01166386
Last Updated: 2022-04-22
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
165 participants
Primary outcome timeframe
Pre, at end of treatment up to one week, six-month follow up
Results posted on
2022-04-22
Participant Flow
Participant milestones
| Measure |
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.
FANCI: comprehensive neurobehavioral sessions with therapist administrating treatment components
|
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.
FANCI: Watching DVDs chosen by participants on various topics.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
83
|
|
Overall Study
COMPLETED
|
79
|
78
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
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.
FANCI: comprehensive neurobehavioral sessions with therapist administrating treatment components
|
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.
FANCI: Watching DVDs chosen by participants on various topics.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
Baseline Characteristics
Acute Neurobehavioral Program for Improving Functional Status After TBI
Baseline characteristics by cohort
| Measure |
First Steps Treatment Intervention
n=82 Participants
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
|
Standard Rehabilitation Care
n=83 Participants
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
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.62 years
STANDARD_DEVIATION 16.75 • n=5 Participants
|
42.21 years
STANDARD_DEVIATION 18.95 • n=7 Participants
|
41.07 years
STANDARD_DEVIATION 18.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
82 participants
n=5 Participants
|
83 participants
n=7 Participants
|
165 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre, at end of treatment up to one week, six-month follow upPopulation: Several persons terminated the intervention project, some files did not get transferred from one of the PIs institutions to another when she changed jobs.
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
Outcome measures
| Measure |
First Steps Treatment Intervention
n=73 Participants
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
|
Standard Rehabilitation Care
n=70 Participants
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.
|
|---|---|---|
|
Functional Independence Measure Scores
baseline
|
88.11 units on a scale
Standard Deviation 10.26
|
89.79 units on a scale
Standard Deviation 12.29
|
|
Functional Independence Measure Scores
at end of treatment up to one week
|
120.57 units on a scale
Standard Deviation 7.32
|
119.67 units on a scale
Standard Deviation 8.03
|
|
Functional Independence Measure Scores
six month follow-up
|
48.98 units on a scale
Standard Deviation 16.65
|
50.93 units on a scale
Standard Deviation 14.86
|
SECONDARY outcome
Timeframe: Pre, post, six month follow upThe 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.
Outcome measures
| Measure |
First Steps Treatment Intervention
n=73 Participants
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
|
Standard Rehabilitation Care
n=69 Participants
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.
|
|---|---|---|
|
Neurobehavioral Rating Scale
baseline
|
56.23 units on a scale
Standard Deviation 12.83
|
58.70 units on a scale
Standard Deviation 13.60
|
|
Neurobehavioral Rating Scale
post-treatment
|
48.4857 units on a scale
Standard Deviation 9.94003
|
50.2985 units on a scale
Standard Deviation 10.51264
|
|
Neurobehavioral Rating Scale
follow-up
|
48.9778 units on a scale
Standard Deviation 16.64808
|
50.9318 units on a scale
Standard Deviation 14.85495
|
Adverse Events
First Steps Treatment Intervention
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Rehabilitation Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
First Steps Treatment Intervention
n=82 participants at risk
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
|
Standard Rehabilitation Care
n=83 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
stroke
|
1.2%
1/82
|
0.00%
0/83
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Janet Niemeier
Carolinas Healthcare System, Carolinas Medical Center
Phone: 704 355 2046
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place