Trial of a Decision Support Intervention for Adolescents and Young Adults With Ulcerative Colitis (iBDecide)

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Ulcerative Colitis, Pediatric

Treatments: Other: iBDecide Decision Support Application

Study type: Interventional

Funder types: Other

Identifiers

NCT04207008

2019-1103a

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 14 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

iBDecide App Decision-support Arm

Experimental group

Description:

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.

Treatment:

Other: iBDecide Decision Support Application

Control Arm

No Intervention group

Description:

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.