Behavioral and Educational Tools to Improve Epilepsy Care

NCT ID: NCT02646631

Last Updated: 2018-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-11-20

Brief Summary

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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

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Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Usual Treatment

Group Type EXPERIMENTAL

Usual Care

Intervention Type OTHER

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

Educational Materials

Intervention Type OTHER

Printed educational materials on the management of epilepsy

MORE

Group Type EXPERIMENTAL

Usual Care

Intervention Type OTHER

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

Management of Risks in Epilepsy (MORE)

Intervention Type 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.

Educational Materials

Intervention Type OTHER

Printed educational materials on the management of epilepsy

MORE + MI

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

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

Management of Risks in Epilepsy (MORE)

Intervention Type 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)

Intervention Type 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.

Educational Materials

Intervention Type OTHER

Printed educational materials on the management of epilepsy

Interventions

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Usual Care

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

Intervention Type OTHER

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Educational Materials

Printed educational materials on the management of epilepsy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tanya Spruill

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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15-01386

Identifier Type: -

Identifier Source: org_study_id