Impact of Neuropsychological Evaluation on Epilepsy Treatment
Primary Purpose
Epilepsy
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Neuropsychological testing
Sponsored by
About this trial
This is an interventional health services research trial for Epilepsy
Eligibility Criteria
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
Sites / Locations
- University of South FloridaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Neuropsychological testing
Treatment as usual
Arm Description
Participants from this group will be administered a neuropsychological battery in addition to the initial and follow-up surveys
Participants from this group will be administered the initial and follow-up survey.
Outcomes
Primary Outcome Measures
Epilepsy Outcome Study Survey
A brief questionnaire regarding the participants views on their epilepsy treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT03202082
First Posted
June 26, 2017
Last Updated
June 26, 2017
Sponsor
University of South Florida
1. Study Identification
Unique Protocol Identification Number
NCT03202082
Brief Title
Impact of Neuropsychological Evaluation on Epilepsy Treatment
Official Title
Impact of Neuropsychological Evaluation on Epilepsy Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
June 30, 2018 (Anticipated)
Study Completion Date
June 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neuropsychological testing
Arm Type
Experimental
Arm Description
Participants from this group will be administered a neuropsychological battery in addition to the initial and follow-up surveys
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Participants from this group will be administered the initial and follow-up survey.
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological testing
Intervention Description
Neuropsychological testing evaluates various aspects of a participants cognitive ability as well as mood.
Primary Outcome Measure Information:
Title
Epilepsy Outcome Study Survey
Description
A brief questionnaire regarding the participants views on their epilepsy treatment
Time Frame
2-4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mike R Schoenberg, Ph.D
Phone
813-974-8900
Email
mschoenb@health.usf.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Neuropsychological Evaluation on Epilepsy Treatment
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