Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01166386 |
| Other study ID # |
1R01HD052922-06 |
| Secondary ID |
1R01HD052922-01A |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2008 |
| Est. completion date |
January 2014 |
Study information
| Verified date |
March 2018 |
| Source |
Wake Forest University Health Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
