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

Not Applicable

Completed

• Conditions: Ulcerative Colitis, Pediatric
• Interventions: Other: iBDecide Decision Support Application

• Registration Number: NCT04207008
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Study Timeline

• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-18
• Study First Posted: 2019-12-20
• Study Start: 2020-02-07
• Primary Completion: 2020-10-23
• Study Completion: 2021-01-23
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iBDecide App Decision-support Arm	iBDecide Decision Support Application	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of intervention	At clinic visit	The extent to which this intervention impacts the flow of a clinic appointment, as measured by physician perception of visit length and efficiency.
Acceptability of intervention	One week after clinic visit	The extent to which patients and physicians feel the intervention is appropriate and useful. This is measured through adaptations of the System Usability Scale and the decision aid acceptability measure.

Secondary Outcome Measures

Name	Time	Method
Decisional conflict	At clinic visit	Measure of decisional uncertainty, assessed via Decisional Conflict Scale.
Perceived Shared Decision making	One week after clinic visit	Degree of shared decision-making the patient and physician each report, measured by the Shared Decision-Making Questionnaire-9 and Shared Decision-making Questionnaire 9-doc.
Decision preference congruence	One week after clinic visit	Extent to which the patients' role in the decision process matched their preferred role, measured via the Control Preference Scale.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States