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Completed

NCT Number: NCT03639233

Youth Epilepsy and Successful Self-Management Intervention

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YESS!

Behavioral

Web based self-management education

Primary outcomes

  1. Feasibility of recruiting and enrollment procedures and

    Time frame: 8 weeks after getting access to the web intervention

    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

  2. Acceptability of intervention website users

    Time frame: 8 weeks after getting access to the web intervention

    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 outcomes

  1. Participant Well-being

    Time frame: 8 weeks after getting access to the web intervention and 8 weeks after that.

    measures of overall well-being (EPOCH wellbeing meausre)

  2. Participant Quality of Life

    Time frame: 8 weeks after getting access to the web intervention and 8 weeks after that.

    measure quality of life in epilepsy (QoLiE-10)

  3. self-management behavior profile

    Time frame: 8 weeks after getting access to the web intervention and 8 weeks after that.

    measure the frequency of self management behaviors (taking medications, making clinic appointments, speaking with doctor/nurse/teacher) using a measure developed for this study

  4. self-management motivation profile

    Time frame: 8 weeks after getting access to the web intervention and 8 weeks after that.

    measure the motivations (autonomous and extrinsic reasons for engaging in self management) using an adapted version of a standardized measure of motivation

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Acronym: YESS!

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 21, 2018
Registry last updated
Oct 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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