Impact of Neuropsychological Evaluation on Epilepsy Treatment
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2015
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 26, 2017
CompletedFirst Posted
Study publicly available on registry
June 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedJune 28, 2017
June 1, 2017
3 years
June 26, 2017
June 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Epilepsy Outcome Study Survey
A brief questionnaire regarding the participants views on their epilepsy treatment
2-4 months
Study Arms (2)
Neuropsychological testing
EXPERIMENTALParticipants from this group will be administered a neuropsychological battery in addition to the initial and follow-up surveys
Treatment as usual
NO INTERVENTIONParticipants from this group will be administered the initial and follow-up survey.
Interventions
Neuropsychological testing evaluates various aspects of a participants cognitive ability as well as mood.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Previously undergone neuropsychological testing
- Currently pursuing surgical treatment for epilepsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of South Florida
Tampa, Florida, 33612, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2017
First Posted
June 28, 2017
Study Start
July 1, 2015
Primary Completion
June 30, 2018
Study Completion
June 30, 2018
Last Updated
June 28, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share