Acute Neurobehavioral Program for Improving Functional Status After TBI
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 19, 2010 | ||||||||
| Last Updated Date | March 12, 2012 | ||||||||
| Start Date ICMJE | March 2008 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Functional Independence Measure scores [ Time Frame: Pre, post, six-month follow up ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01166386 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Neurobehavioral Rating Scale [ Time Frame: Pre, post, six month follow up ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Acute Neurobehavioral Program for Improving Functional Status After TBI | ||||||||
| Official Title ICMJE | An Acute Neurobehavioral Program for Improving Functional Status After TBI | ||||||||
| Brief Summary | More than 1.4 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Traumatic Brain Injury | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 150 | ||||||||
| Estimated Completion Date | September 2013 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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 - |
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01166386 | ||||||||
| Other Study ID Numbers ICMJE | 1RO1HD052922-01A2, 5R01HD052922, 1RO1HD052922-01A2 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Virginia Commonwealth University | ||||||||
| Study Sponsor ICMJE | Virginia Commonwealth University | ||||||||
| Collaborators ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Virginia Commonwealth University | ||||||||
| Verification Date | March 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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