- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02970396
Self-management for People With Epilepsy and a History of Negative Health Events (SMART)
Self-management for People With Epilepsy and a History of Negative Health Events (SMART)
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44106
- Case Western Reserve University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: SMART Intervention
Participants (a total of 120 individuals) will be randomly assigned to either SMART (N=60) or the wait-list control (N= 60), in a 1:1 ratio.
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Active Comparator: Wait-list
Participants assigned to the wait-list will start the SMART intervention 6 months following randomization.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in number of negative health events
Time Frame: baseline, 6 months
|
baseline, 6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-14-07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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