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

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
self-management
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Case Western Reserve University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SMART Intervention

Wait-list

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in number of negative health events

Secondary Outcome Measures

Full Information

First Posted
November 18, 2016
Last Updated
December 13, 2018
Sponsor
Case Western Reserve University
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1. Study Identification

Unique Protocol Identification Number
NCT02970396
Brief Title
Self-management for People With Epilepsy and a History of Negative Health Events
Acronym
SMART
Official Title
Self-management for People With Epilepsy and a History of Negative Health Events (SMART)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMART Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Wait-list
Arm Type
Active Comparator
Arm Description
Participants assigned to the wait-list will start the SMART intervention 6 months following randomization.
Intervention Type
Behavioral
Intervention Name(s)
self-management
Primary Outcome Measure Information:
Title
Change in number of negative health events
Time Frame
baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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

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