Recruiting

Observational Study

Sponsor:

University of Michigan

Code:

NCT06817213

Conditions

Eosinophilic Esophagitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

General education control

Decision support tool

Study Details

Brief 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.

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

Study ID

NCT06817213

Start date

Apr 16, 2025

Status verified date

Sep, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct 6, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: General education control group

General educational materials

experimental: Decision support tool group

Tailored educational materials

Interventions

General education control

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 tool

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.

Primary outcome measure

  • Feasibility: measured as the proportion of eligible patients that consent to participate in the study [ Time Frame: Recruitment period approximately 18 months ]
  • Acceptability: measured on a 4-point Likert scale [ Time Frame: Approximately 4 months ]

Central Contacts and Locations

Central contacts

Kelcie Brophy

734-615-0531kelcieb@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Kelcie Brophy

734-615-0531kelcieb@umich.edu

Principal Investigator:

Joy Chang, MD, MS

More Information

Sponsor

University of Michigan

Last update posted

Sep 23, 2026

Last verified

Sep, 2026

Keywords

  • tailored educational materials
  • general educational materials
  • online surveys
  • decision aid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-11. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.