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CompletedNCT02970396SMARTUpdated Dec 17, 2018

Self-management for People With Epilepsy and a History of Negative Health Events

An interventional study of self-management in Epilepsy, sponsored by Case Western Reserve University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-17.

Sponsored by Case Western Reserve University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
121
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

This is an investigation of adult individuals with epilepsy, and involves educational and behavioral interventions intended to enhance treatment adherence and self-management.

The investigators are adapting a self-management intervention that they developed in a previous study to individuals with epilepsy and a history of negative health events (NHEs), such as accidents and emergency department (ED) visits, diminished quality of life and poor mental well-being. The intervention "Self-management for people with epilepsy and a history of negative health events (SMART)" is intended to reduce NHEs and improve quality of life in people with epilepsy associated with historically disadvantaged groups.

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Conditions studied

  • Epilepsy

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In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 121 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Case Western Reserve University is the lead sponsor of 158 studies on the registry; 29 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of epilepsy
  • Negative health event within the last 6 months
  • Able to provide written consent and participate in study procedures

Exclusion criteria

Exclusion Criteria:

  • Immediate risk of self-harm
  • Dementia
  • Pregnancy
  • Unable to read/understand English
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
121 participants (actual)

Study arms

  • Active comparator
    SMART Intervention

    Participants (a total of 120 individuals) will be randomly assigned to either SMART (N=60) or the wait-list control (N= 60), in a 1:1 ratio.

    Behavioral: self-management

  • Active comparator
    Wait-list

    Participants assigned to the wait-list will start the SMART intervention 6 months following randomization.

    Behavioral: self-management

Interventions

  • Behavioralself-management
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What researchers measure

Primary outcomes

  1. Change in number of negative health events

    Time frame: baseline, 6 months

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Study locations

1 site
  • Case Western Reserve University
    Cleveland, Ohio 44106, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02970396
Lead sponsor
Case Western Reserve University
Responsible party
Martha Sajatovic, MD (Professor, Case Western Reserve University) — Principal investigator
First posted
Nov 22, 2016
Start date
Sep 2014
Primary completion
Dec 2018
Completion
Dec 2018
Last update
Dec 17, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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