Recruiting

Observational Study

Sponsor:

University of Wisconsin, Madison

Code:

NCT06257082

Conditions

Diabetic Retinopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Online Survey

Study Details

Brief summary:

An online survey (n=1,500) and 4 focus groups will be conducted with Latinx patients with diabetes (n=20) to obtain preliminary data regarding whether and how patient and clinician video testimonial interventions (n=6) increase eye health literacy and trust in healthcare.

Conditions

Diabetic Retinopathy

Study ID

NCT06257082

Start date

May 21, 2025

Status verified date

May, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria (online survey participants):

  • Self-Identifies as Hispanic or Latino

Inclusion Criteria (patient video testimonials):

  • Self-Identifies as Hispanic or Latino
  • diagnosed with diabetes
  • treated at Access Community Health Centers and UW Health in Madison, WI

Inclusion Criteria (clinician video testimonials):

  • Self-Identifies as Hispanic or Latino
  • clinician who treats patients with diabetes at Access Community Health Centers and UW Health in Madison, WI

Inclusion Criteria (focus group participants):

  • Self-Identifies as Hispanic or Latino
  • diagnosed with type 1 or type 2 diabetes

Exclusion Criteria:

\-

Study Design

Enrollment

1526 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Patient plus Clinician Combined Testimonials

In addition to being randomized for online survey participants, focus groups will view patient plus clinician combined testimonials.

active comparator: Clinician Only Testimonials

active comparator: Patient Only Testimonials

active comparator: National Eye Institute video Control

active comparator: Pre-video questionnaire-only Control

Interventions

Online Survey

Participants must self-identify as Latinx adults and complete a brief online survey adapted from validated survey instruments for eye health literacy and trust in healthcare (CADEES and T-HCT scale) both before and after viewing the video-based, patient education intervention to obtain a pre to post-comparison of any differences in their responses.

Primary outcome measure

  • Change in Eye Health Literacy as measured by Compliance with Annual Diabetic Eye Exams Survey (CADEES) [ Time Frame: pre and post video testimonial intervention (up to 90 minutes) ]

Central Contacts and Locations

Central contacts

Cinthya Maldonado

608-265-5777cmaldonado5@wisc.edu

Yao Liu, MD, MS

608-263-1481yao.liu2@wisc.edu

Locations

UW Hospital and Clinics

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • teleophthalmology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-05-14.