NCT02646631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2017

Completed
Last Updated

December 24, 2018

Status Verified

December 1, 2018

Enrollment Period

1.2 years

First QC Date

January 4, 2016

Last Update Submit

December 20, 2018

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (7)

  • Number of patients who complete the study

    3 months

  • Percentage of MI sessions completed

    3 months

  • Percentage of diary entries completed

    3 months

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

    3 months

  • Seizure frequency

    3 months

  • +2 more secondary outcomes

Study Arms (3)

Usual Treatment

EXPERIMENTAL
Other: Usual CareOther: Educational Materials

MORE

EXPERIMENTAL
Other: Usual CareBehavioral: Management of Risks in Epilepsy (MORE)Other: Educational Materials

MORE + MI

ACTIVE COMPARATOR
Other: Usual CareBehavioral: Management of Risks in Epilepsy (MORE)Behavioral: Telephone-based motivational interviewing (MORE+MI)Other: Educational Materials

Interventions

Usual CareOTHER

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

MOREMORE + MIUsual Treatment
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.

MOREMORE + MI
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.

MORE + MI
Educational MaterialsOTHER

Printed educational materials on the management of epilepsy

MOREMORE + MIUsual Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Known or suspected psychogenic nonepileptic seizures as sole seizure type
  • Active psychotic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Tanya Spruill

    New York University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 5, 2016

Study Start

September 1, 2016

Primary Completion

November 20, 2017

Study Completion

November 20, 2017

Last Updated

December 24, 2018

Record last verified: 2018-12

Locations

US(1)