Behavioral and Educational Tools to Improve Epilepsy Care

Epilepsy Clinical Trial

Official title:

Behavioral and Educational Tools to Improve Epilepsy Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02646631
• Other study ID #: 15-01386
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: November 20, 2017

Study information

• Verified date: December 2018
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 20, 2017
• Est. primary completion date: November 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• Usual Care
Participants assigned to this treatment will receive the usual care as determined by their physician

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.
• 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.

Other:
• Educational Materials
Printed educational materials on the management of epilepsy

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent adherence to anti-epileptic drug schedule (pill counts)		3 months
Secondary	Number of patients who complete the study		3 months
Secondary	Percentage of MI sessions completed		3 months
Secondary	Percentage of diary entries completed		3 months
Secondary	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
Secondary	Seizure frequency		3 months
Secondary	Quality of life as measured by the Quality of Life in Epilepsy questionnaire score		3 months
Secondary	Quality of life as measured by the PROMIS-10 questionnaire score		3 months