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

NCT04207008 | Completed

• 1 other identifier: 2019-1103a
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis, Pediatric

Keywords

Adolescents and young adults; decision making

Outcome Measures

Primary Outcomes (2)

• Feasibility of intervention

  The extent to which this intervention impacts the flow of a clinic appointment, as measured by physician perception of visit length and efficiency.

  At clinic visit

• Acceptability of intervention

  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.

  One week after clinic visit

Secondary Outcomes (3)

• Decisional conflict

  At clinic visit

• Perceived Shared Decision making

  One week after clinic visit

• Decision preference congruence

  One week after clinic visit

Study Arms (2)

iBDecide App Decision-support Arm

EXPERIMENTAL

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.

Other: iBDecide Decision Support Application

Control Arm

NO INTERVENTION

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.

Interventions

iBDecide Decision Support Application OTHER

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.

iBDecide App Decision-support Arm

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Unable to read or speak English

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• 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.

  PMID: 36161973 DERIVED

MeSH Terms

Conditions

Pediatric ulcerative colitis

Study Officials

• Ellen Lipstein, MD, MPH

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 20, 2019
• Study Start: February 7, 2020
• Primary Completion: October 23, 2020
• Study Completion: January 23, 2021
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)