Ulcerative ColitisNCT02065089
Development of 'Emma'--a Pediatric IBD Quiz
A study testing playing the ipad quiz game in people with Ulcerative Colitis and Crohn's Disease, run by Mayo Clinic at 2 sites in United States.
Trial summary
We would like to collaborate and further develop an ipad-based, interactive quiz game 'Emma'; to identify gaps in knowledge of inflammatory bowel disease in pediatric patients. These gaps can be used to improve patient education. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease, Inflammatory Bowel Disease
- What is being tested?
- playing the ipad quiz game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Feb 2014to 5 Jan 2017
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children 10-18 years of age
- Diagnosis of Crohn's disease or ulcerative colitis
- English-speaking
- Established patient of participating institution
Who cannot join
- Inability to understand and read English at a grade 5-12 year level, as commensurate to their chronological age
- Research denial by patient or guardian
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Development of an Electronic Pediatric Inflammatory Bowel Disease Quiz
We would like to collaborate and further develop an ipad-based, interactive quiz game 'Emma'; to identify gaps in knowledge of inflammatory bowel disease in pediatric patients. These gaps can be used to improve patient education.
- Being tested
- playing the ipad quiz game
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
playing the ipad quiz gameOther
Individualized education to the patient via the quiz game, with optional additional education provided by medical providers.
| Study group | Role | What they receive |
|---|---|---|
| playing the ipad quiz game | Experimental | There will only be one arm--any patient who consents to participate in the intervention (playing the ipad quiz game) Receives: Other: playing the ipad quiz game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in patient knowledge of inflammatory bowel disease
The patient will play the ipad quiz game at office visits over time. We will look for improvements in overall knowledge of IBD, as well as subcategories (ex. nutrition, medications, etc.)
Measured: baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study start6 Feb 2014
- Primary completion5 Jan 2017
- Study completion5 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeanne Tung, Mayo Clinic
- Investigators
- Jeanne Tung, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065089
- Sponsor's protocol ID
- 13-000584
- Status last verified
- Apr 2018
- First submitted
- 14 Feb 2014
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Electronic Pediatric Inflammatory Bowel Disease Quiz
- ClinicalTrials.gov ID
- NCT02065089
- Acronym / sponsor ID
- 13-000584
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 Feb 2014 (actual)
- Primary completion
- 5 Jan 2017 (actual)
- Study completion
- 5 Jan 2017 (actual)
- First posted
- 17 Feb 2014 (estimated)
- 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.
We would like to collaborate and further develop an ipad-based, interactive quiz game 'Emma'; to identify gaps in knowledge of inflammatory bowel disease in pediatric patients. These gaps can be used to improve patient education.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| playing the ipad quiz game | Experimental | Other: playing the ipad quiz gameThere will only be one arm--any patient who consents to participate in the intervention (playing the ipad quiz game) |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children 10-18 years of age
- Diagnosis of Crohn's disease or ulcerative colitis
- English-speaking
- Established patient of participating institution
Key exclusion criteria (2 listed)
- Inability to understand and read English at a grade 5-12 year level, as commensurate to their chronological age
- Research denial by patient or guardian
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 |
|---|---|---|
| playing the ipad quiz gameIndividualized education to the patient via the quiz game, with optional additional education provided by medical providers. | Other | playing the ipad quiz game |
Primary outcome
Improvement in patient knowledge of inflammatory bowel disease
Time frame: baseline to 18 months
The patient will play the ipad quiz game at office visits over time. We will look for improvements in overall knowledge of IBD, as well as subcategories (ex. nutrition, medications, etc.)
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 13 Apr 2018.
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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.
Jeanne Tung, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing playing the ipad quiz game in people with Ulcerative Colitis and Crohn's Disease, run by Mayo Clinic at 2 sites 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 4 inclusion and 2 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 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Improvement in patient knowledge of inflammatory bowel disease (time frame: baseline to 18 months). 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 13 Apr 2018.