Youth Epilepsy and Successful Self-Management Intervention

NCT03639233 | Completed

• 1 other identifier: STUDY00003214
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Participant Well-being

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

• Participant Quality of Life

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

• self-management behavior profile

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

• self-management motivation profile

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

Study Arms (1)

Arm 1

OTHER

Intervention access

Behavioral: YESS!

Interventions

YESS! BEHAVIORAL

Web based self-management education

Arm 1

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Peter Scal, MD MPH

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 21, 2018
• Study Start: October 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: October 30, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)