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

December 13, 2018 updated by: Martha Sajatovic, MD, Case Western Reserve University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in number of negative health events
Time Frame: baseline, 6 months
baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Western Reserve University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

November 18, 2016

First Submitted That Met QC Criteria

November 21, 2016

First Posted (Estimate)

November 22, 2016

Study Record Updates

Last Update Posted (Actual)

December 17, 2018

Last Update Submitted That Met QC Criteria

December 13, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-14-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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