Ulcerative Colitis, Pediatric
Conditions
Keywords
Adolescents and young adults, decision making
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.
Interventions
OTHERiBDecide 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.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
14 Years to 25 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed