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

Ulcerative Colitis, Pediatric Clinical Trial

— iBDecide  

Official title:

iBDecide Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04207008
• Other study ID #: 2019-1103a
• Status: Completed
• Phase: N/A
• Start date: February 7, 2020
• Est. completion date: January 23, 2021

Study information

• Verified date: February 2021
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 23, 2021
• Est. primary completion date: October 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis, Pediatric

Intervention

Other:
• iBDecide Decision Support Application
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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Decisional conflict	Measure of decisional uncertainty, assessed via Decisional Conflict Scale.	At clinic visit
Secondary	Perceived Shared Decision making	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.	One week after clinic visit
Secondary	Decision preference congruence	Extent to which the patients' role in the decision process matched their preferred role, measured via the Control Preference Scale.	One week after clinic visit