Traumatic Brain Injury
Conditions
Keywords
rehabilitation, brain injury
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.
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.
Interventions
BEHAVIORALFANCI
comprehensive neurobehavioral sessions with therapist administrating treatment components
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 82 |
| 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. | 83 |
| Total | 165 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 5 |
Baseline characteristics
| Characteristic | First Steps Treatment Intervention | Total | Standard Rehabilitation Care |
|---|---|---|---|
| Age, Continuous | 39.62 years STANDARD_DEVIATION 16.75 | 41.07 years STANDARD_DEVIATION 18.13 | 42.21 years STANDARD_DEVIATION 18.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 79 Participants | 158 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 45 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) White | 52 Participants | 109 Participants | 57 Participants |
| Region of Enrollment United States | 82 participants | 165 participants | 83 participants |
| Sex: Female, Male Female | 23 Participants | 48 Participants | 25 Participants |
| Sex: Female, Male Male | 59 Participants | 117 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 82 | 0 / 83 |
| serious Total, serious adverse events | 1 / 82 | 0 / 83 |
Outcome results
Primary
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
Time frame: Pre, at end of treatment up to one week, six-month follow up
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| First Steps Treatment Intervention | Functional Independence Measure Scores | baseline | 88.11 units on a scale | Standard Deviation 10.26 |
| First Steps Treatment Intervention | Functional Independence Measure Scores | at end of treatment up to one week | 120.57 units on a scale | Standard Deviation 7.32 |
| First Steps Treatment Intervention | Functional Independence Measure Scores | six month follow-up | 48.98 units on a scale | Standard Deviation 16.65 |
| Standard Rehabilitation Care | Functional Independence Measure Scores | baseline | 89.79 units on a scale | Standard Deviation 12.29 |
| Standard Rehabilitation Care | Functional Independence Measure Scores | at end of treatment up to one week | 119.67 units on a scale | Standard Deviation 8.03 |
| Standard Rehabilitation Care | Functional Independence Measure Scores | six month follow-up | 50.93 units on a scale | Standard Deviation 14.86 |
Secondary
Neurobehavioral Rating Scale
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| First Steps Treatment Intervention | Neurobehavioral Rating Scale | baseline | 56.23 units on a scale | Standard Deviation 12.83 |
| First Steps Treatment Intervention | Neurobehavioral Rating Scale | post-treatment | 48.4857 units on a scale | Standard Deviation 9.94003 |
| First Steps Treatment Intervention | Neurobehavioral Rating Scale | follow-up | 48.9778 units on a scale | Standard Deviation 16.64808 |
| Standard Rehabilitation Care | Neurobehavioral Rating Scale | baseline | 58.70 units on a scale | Standard Deviation 13.6 |
| Standard Rehabilitation Care | Neurobehavioral Rating Scale | post-treatment | 50.2985 units on a scale | Standard Deviation 10.51264 |
| Standard Rehabilitation Care | Neurobehavioral Rating Scale | follow-up | 50.9318 units on a scale | Standard Deviation 14.85495 |