Behavioral and Educational Tools to Improve Epilepsy Care

Study Overview
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Brief Summary
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The long-term goal of this research is to improve seizure control among patients with epilepsy, which has the potential to improve quality of life for thousands of people living with epilepsy and reduce health care utilization, social and economic costs, and epilepsy-related mortalities. Participants who are suffering from epilepsy will be randomized to receive usual care (UC), a smartphone-based self-management intervention called Management of Risks in Epilepsy (MORE), or MORE + telephone-based motivational interviewing (MI). Participants will be followed for 3 months.

Official Title
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Behavioral and Educational Tools to Improve Epilepsy Care

Conditions
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Epilepsy

Intervention / Treatment
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* Other: Usual Care
* Behavioral: Management of Risks in Epilepsy (MORE)
* Behavioral: Telephone-based motivational interviewing (MORE+MI)
* Other: Educational Materials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age English- or Spanish-speaking Partial (focal) or generalized epilepsy (as confirmed with epileptiform activity on an electroencephalogram) Poor medication adherence Willing and able to use a smartphone (provided by the study) to manage disease. Exclusion Criteria: Known or suspected psychogenic nonepileptic seizures as sole seizure type Active psychotic disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Usual Treatment<br> | Other: Usual Care<br>* Participants assigned to this treatment will receive the usual care as determined by their physician<br>Other: Educational Materials<br>* Printed educational materials on the management of epilepsy<br>|
| Experimental: MORE<br> | Other: Usual Care<br>* Participants assigned to this treatment will receive the usual care as determined by their physician<br>Behavioral: Management of Risks in Epilepsy (MORE)<br>* MORE is a smartphone application which participants use to record information on a daily basis about seizures (severity, type), medications, and mood and stress levels. It also includes a camera-based application which uses a pill scanner and photo to record the identity and quantity (dose) of medications just prior to them being taken. Also included in the app are medication reminders, educational video clips, and self-management tips.<br>Other: Educational Materials<br>* Printed educational materials on the management of epilepsy<br>|
| Active Comparator: MORE + MI<br> | Other: Usual Care<br>* Participants assigned to this treatment will receive the usual care as determined by their physician<br>Behavioral: Management of Risks in Epilepsy (MORE)<br>* MORE is a smartphone application which participants use to record information on a daily basis about seizures (severity, type), medications, and mood and stress levels. It also includes a camera-based application which uses a pill scanner and photo to record the identity and quantity (dose) of medications just prior to them being taken. Also included in the app are medication reminders, educational video clips, and self-management tips.<br>Behavioral: Telephone-based motivational interviewing (MORE+MI)<br>* Participants will receive a total of 4 motivational interviewing sessions over the phone. These sessions last approximately 20 minutes each and build on the educational materials already provided within the MORE app.<br>Other: Educational Materials<br>* Printed educational materials on the management of epilepsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent adherence to anti-epileptic drug schedule (pill counts) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who complete the study |  | 3 months | 
| Percentage of MI sessions completed |  | 3 months | 
| Percentage of diary entries completed |  | 3 months | 
| Adherence to anti-epileptic drug schedule (self-reported) as measured by the Morisky Medication Adherence Scale | As measured by the Morisky Medication Adherence Scale | 3 months | 
| Seizure frequency |  | 3 months | 
| Quality of life as measured by the Quality of Life in Epilepsy questionnaire score |  | 3 months | 
| Quality of life as measured by the PROMIS-10 questionnaire score |  | 3 months |