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OpenTrials
Completed

NCT Number: NCT04207008

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

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.

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Key information

Conditions

Ulcerative Colitis, Pediatric Pediatric ulcerative colitis

Age range

14 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of intervention

    Time frame: 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.

  2. Acceptability of intervention

    Time frame: 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 outcomes

  1. Decisional conflict

    Time frame: At clinic visit

    Measure of decisional uncertainty, assessed via Decisional Conflict Scale.

  2. Perceived Shared Decision making

    Time frame: 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.

  3. Decision preference congruence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

iBDecide Pilot Randomized Controlled Trial

Acronym: iBDecide

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Dec 20, 2019
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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