EpilepsyYESS!NCT03639233
Youth Epilepsy and Successful Self-Management Intervention
A study testing YESS! in people with Epilepsy, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- YESS!
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- YESS!
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YESS!Behavioural
Web based self-management education
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Intervention access Receives: Behavioral: YESS! |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 8 weeks after getting access to the web intervention
Secondary outcomes (4)
Participant Well-being
measures of overall well-being (EPOCH wellbeing meausre)
Measured: 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)
Measured: 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
Measured: 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
Measured: 8 weeks after getting access to the web intervention and 8 weeks after that.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start1 Oct 2018
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Scal, MD MPH, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639233
- Sponsor's protocol ID
- STUDY00003214
- Acronym
- YESS!
- Status last verified
- Oct 2019
- First submitted
- 13 Aug 2018
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: YESS! is a member of the Managing Epilepsy Well (MEW) and the associated shared database of deidentified participant records
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Youth Epilepsy and Successful Self-Management Intervention
- ClinicalTrials.gov ID
- NCT03639233
- Acronym / sponsor ID
- YESS! / STUDY00003214
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: YESS!Intervention access |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YESS!Web based self-management education | Behavioural | Arm 1 |
Primary outcome
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
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.
4 secondary outcomes
Participant Well-being
Time frame: 8 weeks after getting access to the web intervention and 8 weeks after that.
Participant Quality of Life
Time frame: 8 weeks after getting access to the web intervention and 8 weeks after that.
self-management behavior profile
Time frame: 8 weeks after getting access to the web intervention and 8 weeks after that.
self-management motivation profile
Time frame: 8 weeks after getting access to the web intervention and 8 weeks after that.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Individual participant dataSharing planned: Yes. YESS! is a member of the Managing Epilepsy Well (MEW) and the associated shared database of deidentified participant records
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Scal, MD MPH principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YESS! in people with Epilepsy, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruiting and enrollment procedures and (time frame: 8 weeks after getting access to the web intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.