Video-based Patient Education Intervention for Diabetic Eye Screening in Latinx Communities
Development of a Culturally Adapted, Video-based Patient Education Intervention to Increase Diabetic Eye Screening and Teleophthalmology Use in Latinx Communities
3 other identifiers
interventional
1,526
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2024
CompletedFirst Posted
Study publicly available on registry
February 13, 2024
CompletedStudy Start
First participant enrolled
May 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedJune 3, 2025
June 1, 2025
12 months
February 5, 2024
June 2, 2025
Conditions
Keywords
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 COMPARATORIn addition to being randomized for online survey participants, focus groups will view patient plus clinician combined testimonials.
Clinician Only Testimonials
ACTIVE COMPARATORPatient Only Testimonials
ACTIVE COMPARATORNational Eye Institute video Control
ACTIVE COMPARATORPre-video questionnaire-only Control
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
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
- University of Wisconsin, Madisonlead
- National Eye Institute (NEI)collaborator
Study Sites (1)
UW Hospital and Clinics
Madison, Wisconsin, 53792, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yao Liu, MD, MS
University of Wisconsin, Madison
Central Study Contacts
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
- 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
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.