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NCT Number: NCT06257082

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UW Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Online survey

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.

Primary outcomes

  1. 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)

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

Secondary outcomes

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

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

    T-HCT is scored from 1-5 where higher scores indicate increased trust in healthcare.

Study contacts

Contact information is provided by the study sponsor or research team.

Cinthya Maldonado

CONTACT

[email protected]

608-265-5777

Yao Liu, MD, MS

CONTACT

[email protected]

608-263-1481

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

Development of a Culturally Adapted, Video-based Patient Education Intervention to Increase Diabetic Eye Screening and Teleophthalmology Use in Latinx Communities

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2024
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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