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

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Behavioral: YESS!

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm 1; Intervention access	Behavioral: YESS!; Web based self-management education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 weeks after getting access to the web 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.	8 weeks after getting access to the web intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Well-being	measures of overall well-being (EPOCH wellbeing meausre)	8 weeks after getting access to the web intervention and 8 weeks after that.
Participant Quality of Life	measure quality of life in epilepsy (QoLiE-10)	8 weeks after getting access to the web intervention and 8 weeks after that.
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	8 weeks after getting access to the web intervention and 8 weeks after that.
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	8 weeks after getting access to the web intervention and 8 weeks after that.

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Peter Scal, MD MPH, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 28, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: STUDY00003214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: YESS! is a member of the Managing Epilepsy Well (MEW) and the associated shared database of deidentified participant records

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No