Ulcerative Colitis, PediatriciBDecideNCT04207008
Trial of a Decision Support Intervention for Adolescents and Young Adults With Ulcerative Colitis
A study testing iBDecide Decision Support Application in people with Ulcerative Colitis, Pediatric, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 14 to 25 years
- Conditions the study is for
- Ulcerative Colitis, Pediatric
- What is being tested?
- iBDecide Decision Support Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2020to 23 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Unable to read or speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: iBDecide Pilot Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Ulcerative Colitis, Pediatric
- Being tested
- iBDecide Decision Support Application
- Keywords
- Adolescents and young adults, decision making
- Medical subject headings
- Pediatric ulcerative colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iBDecide Decision Support ApplicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One week after clinic visit
Secondary outcomes (3)
Decisional conflict
Measure of decisional uncertainty, assessed via Decisional Conflict Scale.
Measured: At clinic visit
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.
Measured: One week after clinic visit
Decision preference congruence
Extent to which the patients' role in the decision process matched their preferred role, measured via the Control Preference Scale.
Measured: One week after clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start7 Feb 2020
- Primary completion23 Oct 2020
- Study completion23 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative Colitis, PediatricStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen A. Lipstein MD, MPH, Children's Hospital Medical Center, Cincinnati
- Investigators
- Ellen Lipstein, MD, MPH, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207008
- Sponsor's protocol ID
- 2019-1103a
- Acronym
- iBDecide
- Status last verified
- Feb 2021
- First submitted
- 11 Dec 2019
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36161973
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iBDecide Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04207008
- Acronym / sponsor ID
- iBDecide / 2019-1103a
- Conditions
- Ulcerative Colitis, Pediatric
- Keywords
- Adolescents and young adults, decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 23 Jan 2021 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| iBDecide App Decision-support Arm | Experimental | Other: iBDecide Decision Support ApplicationParticipants 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 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. |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to read or speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iBDecide Decision Support ApplicationThe 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. | Other | iBDecide App Decision-support Arm |
Primary outcome
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.
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.
3 secondary outcomes
Decisional conflict
Time frame: At clinic visit
Perceived Shared Decision making
Time frame: One week after clinic visit
Decision preference congruence
Time frame: One week after clinic visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Derived from this study: PubMed 36161973Matula 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Lipstein, MD, MPH principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iBDecide Decision Support Application in people with Ulcerative Colitis, Pediatric, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intervention (time frame: At clinic visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04207008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.