Youth Epilepsy and Successful Self-Management Intervention

Epilepsy Clinical Trial

— YESS!  

Official title:

Youth Epilepsy and Successful Self-Management Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03639233
• Other study ID #: STUDY00003214
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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:

Related Conditions & MeSH terms

• Epilepsy

Intervention

Behavioral:
• YESS!
Web based self-management education

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.