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Behavioral and Educational Tools to Improve Epilepsy Care

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ClinicalTrials.gov Identifier: NCT02646631
Recruitment Status : Completed
First Posted : January 5, 2016
Last Update Posted : December 24, 2018
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Epilepsy Other: Usual Care Behavioral: Management of Risks in Epilepsy (MORE) Behavioral: Telephone-based motivational interviewing (MORE+MI) Other: Educational Materials Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Behavioral and Educational Tools to Improve Epilepsy Care
Study Start Date : September 2016
Actual Primary Completion Date : November 20, 2017
Actual Study Completion Date : November 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: Usual Treatment Other: Usual Care
Participants assigned to this treatment will receive the usual care as determined by their physician

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

Experimental: MORE 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.

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

Active Comparator: MORE + MI 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.

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.

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




Primary Outcome Measures :
  1. Percent adherence to anti-epileptic drug schedule (pill counts) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02646631


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
UCB Pharma
Investigators
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Principal Investigator: Tanya Spruill New York University Medical School

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02646631     History of Changes
Other Study ID Numbers: 15-01386
First Posted: January 5, 2016    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases