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Youth Epilepsy and Successful Self-Management Intervention (YESS!)

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
YESS!
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age as above
  • Epilepsy diagnosed by a physician
  • Currently taking anti-seizure medications or use device
  • Ability to understand and respond to questions about health and epilepsy
  • Ability to utilize an internet based intervention website

Exclusion Criteria:

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

Intervention access

Outcomes

Primary Outcome Measures

Feasibility of recruiting and enrollment procedures and
Measure the extent to which the recruitment and enrollment procedures meet the study aims in terms of number of participants log in to the intervention
Acceptability of intervention website users
and the extent to which users (study subjects) find the intervention easy to use, enjoyable to use, useful, engaging. Acceptability is a multifaceted and complex concept. As such it it is best examined as a system of interacting attributes.

Secondary Outcome Measures

Participant Well-being
measures of overall well-being (EPOCH wellbeing meausre)
Participant Quality of Life
measure quality of life in epilepsy (QoLiE-10)
self-management behavior profile
measure the frequency of self management behaviors (taking medications, making clinic appointments, speaking with doctor/nurse/teacher) using a measure developed for this study
self-management motivation profile
measure the motivations (autonomous and extrinsic reasons for engaging in self management) using an adapted version of a standardized measure of motivation

Full Information

First Posted
August 13, 2018
Last Updated
October 28, 2019
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT03639233
Brief Title
Youth Epilepsy and Successful Self-Management Intervention
Acronym
YESS!
Official Title
Youth Epilepsy and Successful Self-Management Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed as a pilot test of the YESS! web-based intervention for adolescents with epilepsy. One hundred twenty participants will be given access to the intervention for a period of eight weeks. The investigators are testing the feasibility and acceptability of the the study procedures, measures and of the intervention itself. The study also evaluats the potential for impact on the users.
Detailed Description
YESS! is a web-based self management program developed to enhance the motivation and skills of youth with epilepsy. This clinical trial uses a pre-test, post-test design where all consenting participants are given access to the intervention.

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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Arm Description
Intervention access
Intervention Type
Behavioral
Intervention Name(s)
YESS!
Intervention Description
Web based self-management education
Primary Outcome Measure Information:
Title
Feasibility of recruiting and enrollment procedures and
Description
Measure the extent to which the recruitment and enrollment procedures meet the study aims in terms of number of participants log in to the intervention
Time Frame
8 weeks after getting access to the web intervention
Title
Acceptability of intervention website users
Description
and the extent to which users (study subjects) find the intervention easy to use, enjoyable to use, useful, engaging. Acceptability is a multifaceted and complex concept. As such it it is best examined as a system of interacting attributes.
Time Frame
8 weeks after getting access to the web intervention
Secondary Outcome Measure Information:
Title
Participant Well-being
Description
measures of overall well-being (EPOCH wellbeing meausre)
Time Frame
8 weeks after getting access to the web intervention and 8 weeks after that.
Title
Participant Quality of Life
Description
measure quality of life in epilepsy (QoLiE-10)
Time Frame
8 weeks after getting access to the web intervention and 8 weeks after that.
Title
self-management behavior profile
Description
measure the frequency of self management behaviors (taking medications, making clinic appointments, speaking with doctor/nurse/teacher) using a measure developed for this study
Time Frame
8 weeks after getting access to the web intervention and 8 weeks after that.
Title
self-management motivation profile
Description
measure the motivations (autonomous and extrinsic reasons for engaging in self management) using an adapted version of a standardized measure of motivation
Time Frame
8 weeks after getting access to the web intervention and 8 weeks after that.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age as above Epilepsy diagnosed by a physician Currently taking anti-seizure medications or use device Ability to understand and respond to questions about health and epilepsy Ability to utilize an internet based intervention website Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Scal, MD MPH
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
YESS! is a member of the Managing Epilepsy Well (MEW) and the associated shared database of deidentified participant records

Learn more about this trial

Youth Epilepsy and Successful Self-Management Intervention

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