Epilepsy Clinical Trial
— SMARTOfficial title:
Self-management for People With Epilepsy and a History of Negative Health Events (SMART)
NCT number | NCT02970396 |
Other study ID # | 12-14-07 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2014 |
Est. completion date | December 2018 |
Verified date | December 2018 |
Source | Case Western Reserve University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an investigation of adult individuals with epilepsy, and involves educational and
behavioral interventions intended to enhance treatment adherence and self-management.
The investigators are adapting a self-management intervention that they developed in a
previous study to individuals with epilepsy and a history of negative health events (NHEs),
such as accidents and emergency department (ED) visits, diminished quality of life and poor
mental well-being. The intervention "Self-management for people with epilepsy and a history
of negative health events (SMART)" is intended to reduce NHEs and improve quality of life in
people with epilepsy associated with historically disadvantaged groups.
Status | Completed |
Enrollment | 121 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of epilepsy - Negative health event within the last 6 months - Able to provide written consent and participate in study procedures Exclusion Criteria: - Immediate risk of self-harm - Dementia - Pregnancy - Unable to read/understand English |
Country | Name | City | State |
---|---|---|---|
United States | Case Western Reserve University | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Western Reserve University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in number of negative health events | baseline, 6 months |
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