Behavioral and Educational Tools to Improve Epilepsy Care

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 Overview

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

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MORE	Other: Usual Care; Participants assigned to this treatment will receive the usual care as determined by their physician; Other: Educational Materials; Printed educational materials on the management of epilepsy; Behavioral: Management 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.
Experimental: Usual Treatment	Other: Usual Care; Participants assigned to this treatment will receive the usual care as determined by their physician; Other: Educational Materials; Printed educational materials on the management of epilepsy
Active Comparator: MORE + MI	Other: Usual Care; Participants assigned to this treatment will receive the usual care as determined by their physician; Other: Educational Materials; Printed educational materials on the management of epilepsy; Behavioral: Management 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.; Behavioral: Telephone-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: UCB Pharma
• Investigators: Principal Investigator: Tanya Spruill, New York University Medical School

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): November 20, 2017
• Study Completion (Actual): November 20, 2017

Study Registration Dates

• First Submitted: January 4, 2016
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 5, 2016

Study Record Updates

• Last Update Posted (Actual): December 24, 2018
• Last Update Submitted That Met QC Criteria: December 20, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 15-01386