| Registry | NCT03202082 |
|---|---|
| Status | Unknown |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: double, health services research |
| Enrollment | 100 (Estimated) |
| Sponsor | University of South Florida (Other) |
| Conditions | Epilepsy |
| Interventions | Neuropsychological testing (Behavioral) |
| Dates | start 2015-07-01, primary completion 2018-06-30 (estimated), completion 2018-06-30 (estimated), first posted 2017-06-28, last updated 2017-06-28 |
| Locations | 1 site in United States |
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The present study aims to expand the evidence base of neuropsychological services in the context of medical management of epilepsy, examining whether treatment outcome and patient satisfaction with medical care are significantly improved when neuropsychological evaluation is included as an additional component of medical care within a comprehensive epilepsy center. All participants will complete an initial survey and a follow-up survey regarding views towards their epilepsy treatment. Participants will be randomized into one of two groups. One group will be given a neuropsychological battery in addition to the survey. The primary study hypothesis is that the addition of neuropsychological services to treatment-as-usual will result in significant improvements in (a) satisfaction with medical care, (b) patient perceived treatment outcome, and (c) physician-rated medical compliance. The secondary hypothesis is that participants who undergo neuropsychological evaluation will be generally satisfied with their experience with neuropsychological services.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Neuropsychological testing | Experimental | Behavioral: Neuropsychological testing | Participants from this group will be administered a neuropsychological battery in addition to the initial and follow-up surveys |
| Treatment as usual | No intervention | Participants from this group will be administered the initial and follow-up survey. |
Sex: All, ages: 18 Years to 89 Years
Inclusion Criteria: * 18 years of age or older * experiencing some degree of epilepsy-related symptoms, but not of such severity as to preclude them from being able to provide consent or undergo neuropsychological assessment (requiring extended inpatient treatment, severely aphasic, or MMSE score < 25) Exclusion Criteria: * Previously undergone neuropsychological testing * Currently pursuing surgical treatment for epilepsy
| Facility | City | Country | Status |
|---|---|---|---|
| University of South Florida | Tampa, Florida | United States | Recruiting |