Trial of a Decision Support Intervention for Adolescents and Young Adults With Ulcerative Colitis
NCT ID: NCT04207008
Last Updated: 2021-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2020-02-07
2021-01-23
Brief Summary
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Detailed Description
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Participants will be provided instructions over the phone or via email to download the iBDecide app on their personal smartphone approximately two weeks prior to the scheduled clinic visit. When possible they will download the app during the consent call and the research staff member will review features of the app with the participant. For those unable to download it while talking on the phone, a follow-up phone call will be scheduled to review the features. During the consenting phone call or at the clinic visit, a time will be scheduled to collect additional information via a brief telephone survey approximately one week after the clinic visit. Participants will be sent emails and an electronic calendar invitation to confirm their scheduled telephone interview.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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iBDecide App Decision-support Arm
Participants will download the iBDecide app on their smartphone approximately two weeks prior to the scheduled clinic visit. Approximately one week after the clinic visit, survey data, along with demographic data will be collected from all participants via a brief telephone call. We will collect data on app use between installation and the clinic visit as well as in the 3 months following the clinic visit.
iBDecide Decision Support Application
The iBDecide app provides an electronic tools to learn more about UC, track symptoms, create a nutrition diary, enter reminders for medication and clinic visits, as well as learn more about treatment options and compare UC medications.
Control Arm
Control participants will not use the iBDecide app prior to their clinic visit. They will complete a brief telephone survey approximately one week from clinic visit.
No interventions assigned to this group
Interventions
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iBDecide Decision Support Application
The iBDecide app provides an electronic tools to learn more about UC, track symptoms, create a nutrition diary, enter reminders for medication and clinic visits, as well as learn more about treatment options and compare UC medications.
Eligibility Criteria
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Inclusion Criteria
* 14-25 years of age
* Treatment decision anticipated during clinic
* Did not participate in usability testing for the iBDecide App
* Has a smart phone that can download the iBDecide app
Exclusion Criteria
14 Years
25 Years
ALL
No
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Ellen A. Lipstein MD, MPH
Associate Professor
Principal Investigators
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Ellen Lipstein, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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References
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Matula KA, Minar P, Daraiseh NM, Lin L, Recker M, Lipstein EA. Pilot trial of iBDecide: Evaluating an online tool to facilitate shared decision making for adolescents and young adults with ulcerative colitis. Health Expect. 2022 Dec;25(6):3105-3113. doi: 10.1111/hex.13618. Epub 2022 Sep 26.
Other Identifiers
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2019-1103a
Identifier Type: -
Identifier Source: org_study_id
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