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

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ClinicalTrials.gov Identifier: NCT03639233
Recruitment Status : Completed
First Posted : August 21, 2018
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Epilepsy Behavioral: YESS! Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Youth Epilepsy and Successful Self-Management Intervention
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Arm 1
Intervention access
Behavioral: YESS!
Web based self-management education




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639233


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Peter Scal, MD MPH University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03639233    
Other Study ID Numbers: STUDY00003214
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: YESS! is a member of the Managing Epilepsy Well (MEW) and the associated shared database of deidentified participant records

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases