Epilepsy
Conditions
Brief summary
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.
Interventions
OTHERUsual Care
Participants assigned to this treatment will receive the usual care as determined by their physician
BEHAVIORALManagement of Risks in Epilepsy (MORE)
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.
BEHAVIORALTelephone-based motivational interviewing (MORE+MI)
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.
OTHEREducational Materials
Printed educational materials on the management of epilepsy
Sponsors
UCB Pharma
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 18 years of age 2. English- or Spanish-speaking 3. Partial (focal) or generalized epilepsy (as confirmed with epileptiform activity on an electroencephalogram) 4. Poor medication adherence 5. Willing and able to use a smartphone (provided by the study) to manage disease.
Exclusion criteria
1. Known or suspected psychogenic nonepileptic seizures as sole seizure type 2. Active psychotic disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent adherence to anti-epileptic drug schedule (pill counts) | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 3 months | As measured by the Morisky Medication Adherence Scale |
| Number of patients who complete the study | 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 | — |
| Seizure frequency | 3 months | — |
Countries
United States
Outcome results
None listed