Video-based Patient Education Intervention for Diabetic Eye Screening in Latinx Communities

NCT ID: NCT06257082

Last Updated: 2025-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1526 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-21

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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3 Latinx patients with diabetes and 3 Latinx clinicians will be recruited to videotape testimonials regarding the importance of diabetic eye screening and teleophthalmology use from their personal experiences. The investigators will structure the testimonials as a series of responses to a brief set of interview questions, or prompts, designed to elicit key messages previously identified by our community stakeholders as being particularly important, based on our prior studies and those of others and conducted in Spanish (with English subtitles).

After the Latinx patient and clinician video testimonials are recorded, a community outreach specialist bilingual in Spanish and English will facilitate a series of 4 community stakeholder meetings (90 min. each) to develop the culturally-adapted, video-based patient education intervention to increase diabetic eye screening and teleophthalmology use among Latinos.

After patient education videos are developed, an online survey will be conducted (n=1500) to test 3 versions of the video-based patient education intervention: (1) patient + clinician combined testimonials, (2) patient testimonials only, (3) clinician testimonials only, and compare them to 2 control conditions: (1) a standard educational video, publicly available online from the National Eye Institute, and (2) pre-video questionnaire-only control in a mixed-effects randomized design with pre- and post-measures (video conditions treated as the between-subjects factor).

Finally, a community outreach specialist bilingual in Spanish and English will facilitate focus groups (60-90 minutes) in the participants' preferred language (participants will be grouped based on their preference for either Spanish or English). Focus groups will begin by having each participant complete a brief survey instrument that will be read aloud and adapted from validated survey instruments for eye health literacy and trust in healthcare (CADEES and T-HCT scale). Participants will then silently view the video-based, patient education intervention (patient + clinician combined version). Afterwards, they will complete the same brief survey instrument to obtain a pre-/post-comparison of any differences in their responses that may result from viewing the video intervention.

Together with the online survey results, the investigators will test the intervention's ability to increase eye health literacy and trust in healthcare for obtaining eye care.

Conditions

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Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Patient plus Clinician Combined Testimonials

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

Group Type ACTIVE_COMPARATOR

Online Survey

Intervention Type OTHER

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 Testimonials

Group Type ACTIVE_COMPARATOR

Online Survey

Intervention Type OTHER

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.

Patient Only Testimonials

Group Type ACTIVE_COMPARATOR

Online Survey

Intervention Type OTHER

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.

National Eye Institute video Control

Group Type ACTIVE_COMPARATOR

Online Survey

Intervention Type OTHER

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.

Pre-video questionnaire-only Control

Group Type ACTIVE_COMPARATOR

Online Survey

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Eye Institute (NEI)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yao Liu, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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UW Hospital and Clinics

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cinthya Maldonado

Role: CONTACT

608-265-5777

Yao Liu, MD, MS

Role: CONTACT

608-263-1481

Related Links

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https://www.hipxchange.org/I-SITE

A Guide to Implementation for Sustained Impact in Teleophthalmology (I-SITE)

https://clinicaltrials.gov/study/NCT05773495

Implementation of Teleophthalmology in Urban Health Systems Study

Other Identifiers

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A536000

Identifier Type: OTHER

Identifier Source: secondary_id

1UG1EY032446-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2024-1566

Identifier Type: -

Identifier Source: org_study_id

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