Status:
COMPLETED
Self-management for People with Epilepsy
Lead Sponsor:
Mark A. Granner
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
Epilepsy
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
SMART is a program for adult individuals with sub-optimally controlled epilepsy. It involves educational and behavioral interventions intended to enhance epilepsy self-management. The group sessions ...
Detailed Description
In spite of advances in biological therapies, many people with epilepsy have poor outcomes including negative health events (NHEs), such as frequent seizures, accidents, and emergency department visit...
Eligibility Criteria
Inclusion
- Have received a previous diagnosis of epilepsy
- Be at least 18 years old
- Have experienced at least 1 NHE in the previous 6 months. NHEs that are obviously not related to having epilepsy, any other health condition, or related to personal activities or behavior (for example, being involved in a bus accident while one is a passenger on the bus) will not be counted as NHEs for this study.
- Be able to speak and understand English
- Be able to provide written, informed consent to study participation or have a legally authorized representative
Exclusion
- Actively suicidal/homicidal
- Individuals with a diagnosis of dementia
- Individuals who are unable to provide written informed consent to participate in study and who do not have a legally authorized representative or individuals who are unable to participate in study procedures.
- Pregnant women
- Individuals who participated in Phase I of the study
Key Trial Info
Start Date :
May 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2024
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04705441
Start Date
May 19 2021
End Date
December 3 2024
Last Update
February 3 2025
Active Locations (2)
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1
University of Iowa
Iowa City, Iowa, United States, 52242
2
Case Western Reserve University
Cleveland, Ohio, United States, 44106