Clinical trial NCT04207008: Trial of a Decision Support Intervention for Adolescents and Young Adults With Ulcerative Colitis
Official title: iBDecide Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis, Pediatric
Keywords: Adolescents and young adults
decision making
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 42
Sex: ALL
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: OTHER

Brief summary: A web application decision support tool has been developed for adolescents and young adults (AYAs). The purpose of this pilot trial is to test the web application for adolescent and young adults (AYAs) with Ulcerative Colitis (UC). This research will assess acceptability, feasibility of the decision support intervention for AYA UC patients. Participants will be randomized to usual care or usual care plus the web application prior to an upcoming clinic visit in Gastroenterology. Participants will complete surveys one week after their clinic visit about decision making preferences and, for those in the intervention group, usability and acceptability of the web application.

Detailed description: The iBDecide app provides participants with 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.

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.

Eligibility criteria: Inclusion Criteria:

* English speaking patients with Ulcerative Colitis that have an appointment at the CCHMC Gastroenterology clinic
* 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:

* Unable to read or speak English

Primary outcomes:
measure: Feasibility of intervention
timeFrame: At clinic visit
measure: Acceptability of intervention
timeFrame: One week after clinic visit
Secondary outcomes:
measure: Decisional conflict
timeFrame: At clinic visit
measure: Perceived Shared Decision making
timeFrame: One week after clinic visit
measure: Decision preference congruence
timeFrame: One week after clinic visit
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Ellen Lipstein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.