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

Primary Purpose

Ulcerative Colitis, Pediatric

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iBDecide Decision Support Application
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ulcerative Colitis, Pediatric focused on measuring Adolescents and young adults, decision making

Eligibility Criteria

14 Years - 25 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

iBDecide App Decision-support Arm

Control Arm

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Decisional conflict
Measure of decisional uncertainty, assessed via Decisional Conflict Scale.
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.
Decision preference congruence
Extent to which the patients' role in the decision process matched their preferred role, measured via the Control Preference Scale.

Full Information

First Posted
December 11, 2019
Last Updated
February 2, 2021
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT04207008
Brief Title
Trial of a Decision Support Intervention for Adolescents and Young Adults With Ulcerative Colitis
Acronym
iBDecide
Official Title
iBDecide Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 7, 2020 (Actual)
Primary Completion Date
October 23, 2020 (Actual)
Study Completion Date
January 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Pediatric
Keywords
Adolescents and young adults, decision making

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iBDecide App Decision-support Arm
Arm Type
Experimental
Arm 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.
Arm Title
Control Arm
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
iBDecide Decision Support Application
Intervention Description
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 Outcome Measure Information:
Title
Feasibility of intervention
Description
The extent to which this intervention impacts the flow of a clinic appointment, as measured by physician perception of visit length and efficiency.
Time Frame
At clinic visit
Title
Acceptability of intervention
Description
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.
Time Frame
One week after clinic visit
Secondary Outcome Measure Information:
Title
Decisional conflict
Description
Measure of decisional uncertainty, assessed via Decisional Conflict Scale.
Time Frame
At clinic visit
Title
Perceived Shared Decision making
Description
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.
Time Frame
One week after clinic visit
Title
Decision preference congruence
Description
Extent to which the patients' role in the decision process matched their preferred role, measured via the Control Preference Scale.
Time Frame
One week after clinic visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Lipstein, MD, MPH
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36161973
Citation
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.
Results Reference
derived

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

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