Behavioral and Educational Tools to Improve Epilepsy Care

Not Applicable

Completed

• Conditions: Epilepsy

• Registration Number: NCT02646631
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-05
• Study Start: 2016-09
• Primary Completion: 2017-11-20
• Study Completion: 2017-11-20
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent adherence to anti-epileptic drug schedule (pill counts)	3 months

Secondary Outcome Measures

Name	Time	Method
Quality of life as measured by the Quality of Life in Epilepsy questionnaire score	3 months
Number of patients who complete the study	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
Percentage of MI sessions completed	3 months
Percentage of diary entries completed	3 months
Quality of life as measured by the PROMIS-10 questionnaire score	3 months
Seizure frequency	3 months

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States