Eosinophilic EsophagitisNCT06817213
Patient-Centered Decision Support for Eosinophilic Esophagitis
A study testing Decision support tool in people with Eosinophilic Esophagitis, run by University of Michigan at 1 site in United States.
Trial summary
The study team is conducting this project to learn more about how patients with eosinophilic esophagitis (EoE) like to use and receive educational materials about treatment options and treatment decision making. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Decision support tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2025to 6 Jan 2027
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New EoE patient evaluations ≥18 years old at University of Michigan (UM) that have an upcoming outpatient visit in a UM-gastroenterology or allergy \& immunology clinic,
- Able to speak and read English.
Who cannot join
- Prisoners and institutionalized individuals due to logistical limitations for use of a web app and follow-up interactions in these populations.
- Patients that have significant cognitive or visual impairment that limits interaction with the decision aid (DA)
- Patients that are terminally ill
- Patients that do not have an email address or reliable access to the internet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient-Centered Decision Support for Eosinophilic Esophagitis: A Pilot Study
The study team is conducting this project to learn more about how patients with eosinophilic esophagitis (EoE) like to use and receive educational materials about treatment options and treatment decision making.
This study will assess the efficacy of a decision support intervention to make decisions about treatment and disease management for patients with EoE and will assess the feasibility and acceptability of the intervention to inform future R01-level studies.
The study team hypothesize that deploying the intervention will be feasible, and it will demonstrate high acceptability among EoE patients. Additionally, that patients that use the intervention (vs general education about EoE) will report greater treatment knowledge, increased readiness to choose a therapy, adherence to therapy, and follow-up.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- General education control, Decision support tool
- Keywords
- tailored educational materials, general educational materials, online surveys, decision aid
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General education controlBehavioural
Participants will complete an online survey before reviewing education material for eosinophilic esophagitis, prior to patient's clinical physician's appointment (this appointment is a standard of care visit). Participants will complete a follow-up survey approximately 3 months after the clinic appointment.
Decision support toolBehavioural
Participants will complete an online survey before reviewing tailored educational materials for eosinophilic esophagitis prior to patient's clinical physician's appointment (this appointment is a standard of care visit). The intervention is a tailored, electronic decision support intervention with a patient-facing decision aid (DA) with three components-EoE knowledge/education, values clarifications, and communication. Tailored feedback from the patient will be given to the patient's provider prior to the visit to facilitate shared decision-making in the visit. Participants will complete a follow-up survey approximately 3 months after the clinic appointment.
| Study group | Role | What they receive |
|---|---|---|
| General education control group | Active comparator | General educational materials Receives: Behavioral: General education control |
| Decision support tool group | Experimental | Tailored educational materials Receives: Behavioral: Decision support tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: measured as the proportion of eligible patients that consent to participate in the study
The study aims to achieve at least 20% consented for eligible patients.
Measured: Recruitment period approximately 18 months
Acceptability: measured on a 4-point Likert scale
Measured on a 4-point Likert-scale (1) Very Unhelpful to (4) Very Helpful. Analyzed as high scores indicate more helpful.
Measured: Approximately 4 months
Secondary outcomes (4)
Effectiveness (within-subjects)
Objective eosinophilic esophagitis knowledge measured on 8 true/false/I don't know questions where wrong or "I don't know" answers are given 0 points and correct answers are given 1 point. Minimum points=0 and Maximum points=8
Measured: Day 1 up to approximately 1 month (after consent prior to standard of care clinic visit)
Effectiveness (between-subjects)
Objective eosinophilic esophagitis knowledge measured on 8 true/false/I don't know questions where wrong or "I don't know" answers are given 0 points and correct answers are given 1 point. Minimum points=0 and Maximum points=8
Measured: Approximately 4 months
Preparation for Decision Making (PrepDM) scale
Preparation for Decision making (PrepDM scale) score is a 10-item questionnaire and is scored on a 0-100 scale, where higher scores indicate participants being well prepared to make decisions after reviewing a decision aid (DA). The Prep-DM scale may be adapted slightly to meet the needs of the target population and the developed decision support tool.
Measured: Approximately 4 months
Completion rates
Measured as the proportion of people that consented and completed all study measures, the pre-test, post-test, and 3-month follow-up survey
Measured: Approximately 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start16 Apr 2025
- Primary completion29 Sep 2026
- Study completion6 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Participants (n-20) will be enrolled into the control arm (general education about EoE), then 20 patients will go into the DA arm. Providers will not be formally consented to have their clinics screened for participants. The study team will coordinate with Gastroenterology and Allergy providers about the initiation of the study. Providers will be informed that the study is launching and given the opportunity to "opt-out".
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joy Chang, University of Michigan
- Investigators
- Joy Chang, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817213
- Sponsor's protocol ID
- HUM00257119
- Other IDs
- 1K23DK129784-01A1
- Status last verified
- Sep 2026
- First submitted
- 4 Feb 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No