NCT06257082

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,526

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 21, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

June 3, 2025

Status Verified

June 1, 2025

Enrollment Period

12 months

First QC Date

February 5, 2024

Last Update Submit

June 2, 2025

Conditions

Keywords

teleophthalmology

Outcome Measures

Primary Outcomes (1)

  • Change in Eye Health Literacy as measured by Compliance with Annual Diabetic Eye Exams Survey (CADEES)

    CADEES is scored from 1-5 where higher scores indicate increase eye health literacy.

    pre and post video testimonial intervention (up to 90 minutes)

Secondary Outcomes (1)

  • Change in Trust in Healthcare as measured by Trust in the Health Care Team (T-HCT) scale score

    pre and post video testimonial intervention (up to 90 minutes)

Study Arms (5)

Patient plus Clinician Combined Testimonials

ACTIVE COMPARATOR

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

Other: Online Survey

Clinician Only Testimonials

ACTIVE COMPARATOR
Other: Online Survey

Patient Only Testimonials

ACTIVE COMPARATOR
Other: Online Survey

National Eye Institute video Control

ACTIVE COMPARATOR
Other: Online Survey

Pre-video questionnaire-only Control

ACTIVE COMPARATOR
Other: Online Survey

Interventions

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.

Clinician Only TestimonialsNational Eye Institute video ControlPatient Only TestimonialsPatient plus Clinician Combined TestimonialsPre-video questionnaire-only Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-Identifies as Hispanic or Latino
  • Self-Identifies as Hispanic or Latino
  • diagnosed with diabetes
  • treated at Access Community Health Centers and UW Health in Madison, WI
  • Self-Identifies as Hispanic or Latino
  • clinician who treats patients with diabetes at Access Community Health Centers and UW Health in Madison, WI
  • Self-Identifies as Hispanic or Latino
  • diagnosed with type 1 or type 2 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UW Hospital and Clinics

Madison, Wisconsin, 53792, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Yao Liu, MD, MS

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cinthya Maldonado

CONTACT

Yao Liu, MD, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2024

First Posted

February 13, 2024

Study Start

May 21, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

June 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

De-identified data regarding patient demographics, whether they obtained diabetic eye screening, had teleophthalmology performed, any vision-threatening eye condition identified by teleophthalmology, and whether they followed-up for in-person eye care if they screened positive will be available to share.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
up to 7 years after the completion of the primary outcome
Access Criteria
contact study PI for access

Locations