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OpenTrials
Completed

NCT Number: NCT02646631

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual Care

Other

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

Management of Risks in Epilepsy (MORE)

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)

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

Other

Printed educational materials on the management of epilepsy

Primary outcomes

  1. Percent adherence to anti-epileptic drug schedule (pill counts)

    Time frame: 3 months

Secondary outcomes

  1. Number of patients who complete the study

    Time frame: 3 months

  2. Percentage of MI sessions completed

    Time frame: 3 months

  3. Percentage of diary entries completed

    Time frame: 3 months

  4. Adherence to anti-epileptic drug schedule (self-reported) as measured by the Morisky Medication Adherence Scale

    Time frame: 3 months

    As measured by the Morisky Medication Adherence Scale

  5. Seizure frequency

    Time frame: 3 months

  6. Quality of life as measured by the Quality of Life in Epilepsy questionnaire score

    Time frame: 3 months

  7. Quality of life as measured by the PROMIS-10 questionnaire score

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • UCB Pharma

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 5, 2016
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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