Behavioral and Educational Tools to Improve Epilepsy Care

NYU Langone Health32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Epilepsy

Interventions

Usual CareOTHER

Participants assigned to this treatment will receive the usual care as determined by their physician

Management of Risks in Epilepsy (MORE)BEHAVIORAL

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.

Telephone-based motivational interviewing (MORE+MI)BEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

New York University School of Medicine

New York, New York, United States

Outcomes

Primary Outcomes

Percent adherence to anti-epileptic drug schedule (pill counts)

Time frame: 3 months

Secondary Outcomes

Number of patients who complete the study

Time frame: 3 months

Percentage of MI sessions completed

Time frame: 3 months

Percentage of diary entries completed

Time frame: 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

Time frame: 3 months

Seizure frequency

Time frame: 3 months

Quality of life as measured by the Quality of Life in Epilepsy questionnaire score

Time frame: 3 months

Quality of life as measured by the PROMIS-10 questionnaire score

Time frame: 3 months

Data from ClinicalTrials.gov

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