Behavioral and Educational Tools to Improve Epilepsy Care
Primary Purpose
Epilepsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual Care
Management of Risks in Epilepsy (MORE)
Telephone-based motivational interviewing (MORE+MI)
Educational Materials
Sponsored by
About this trial
This is an interventional supportive care trial for Epilepsy
Eligibility Criteria
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Usual Treatment
MORE
MORE + MI
Arm Description
Outcomes
Primary Outcome Measures
Percent adherence to anti-epileptic drug schedule (pill counts)
Secondary Outcome Measures
Number of patients who complete the study
Percentage of MI sessions completed
Percentage of diary entries completed
Adherence to anti-epileptic drug schedule (self-reported) as measured by the Morisky Medication Adherence Scale
As measured by the Morisky Medication Adherence Scale
Seizure frequency
Quality of life as measured by the Quality of Life in Epilepsy questionnaire score
Quality of life as measured by the PROMIS-10 questionnaire score
Full Information
NCT ID
NCT02646631
First Posted
January 4, 2016
Last Updated
December 20, 2018
Sponsor
NYU Langone Health
Collaborators
UCB Pharma
1. Study Identification
Unique Protocol Identification Number
NCT02646631
Brief Title
Behavioral and Educational Tools to Improve Epilepsy Care
Official Title
Behavioral and Educational Tools to Improve Epilepsy Care
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
November 20, 2017 (Actual)
Study Completion Date
November 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
UCB Pharma
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Treatment
Arm Type
Experimental
Arm Title
MORE
Arm Type
Experimental
Arm Title
MORE + MI
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Participants assigned to this treatment will receive the usual care as determined by their physician
Intervention Type
Behavioral
Intervention Name(s)
Management of Risks in Epilepsy (MORE)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telephone-based motivational interviewing (MORE+MI)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Educational Materials
Intervention Description
Printed educational materials on the management of epilepsy
Primary Outcome Measure Information:
Title
Percent adherence to anti-epileptic drug schedule (pill counts)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of patients who complete the study
Time Frame
3 months
Title
Percentage of MI sessions completed
Time Frame
3 months
Title
Percentage of diary entries completed
Time Frame
3 months
Title
Adherence to anti-epileptic drug schedule (self-reported) as measured by the Morisky Medication Adherence Scale
Description
As measured by the Morisky Medication Adherence Scale
Time Frame
3 months
Title
Seizure frequency
Time Frame
3 months
Title
Quality of life as measured by the Quality of Life in Epilepsy questionnaire score
Time Frame
3 months
Title
Quality of life as measured by the PROMIS-10 questionnaire score
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanya Spruill
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Behavioral and Educational Tools to Improve Epilepsy Care
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