ClinicalTrials.gg
CompletedNCT06257082Updated Nov 5, 2026

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

An interventional study of Online Survey in Diabetic Retinopathy, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Health services research

Updated Nov 5, 2026Now CompletedEnrollment updatedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
1,811
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 267 studies in Diabetic Retinopathy with a site in United States — 36 open to participants now, 56 under way, 6 of them phase 3. Diabetic Retinopathy · United States.

Enrollment
11th of 196
1,811 · median 72
Started
2025
with 11 others
No phase
53 of 267
10 open now
Registered
229th of 267
by date
Lead sponsor
6 of 267
University of Wisconsin, Madison

Among the 267 studies in Diabetic Retinopathy with a site in United States, this one is the 11th largest by enrollment of the 196 interventional ones, is one of 12 that started in 2025, is one of 53 with no phase, and was the 229th registered.

By phase

267 studies; the count open now beside each. This study's row is marked.

Observational70 · 8 open
No phasethis study53 · 10 open
Phase 252 · 3 open
Phase 331 · 4 open
Phase 129 · 4 open
Phase 420 · 6 open
Phase 1/28 · 0 open
Phase 2/34 · 1 open

By the year they started

First in 1992; this study’s year is marked. 12 started in 2025.

Size and results

Median enrollment 72 across the 196 interventional studies, 161 across the 70 observational. Of the 186 that completed or were terminated, 66 (35%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 267 studies in Diabetic Retinopathy with a site in United States, or all of them as a file.
02

Study 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.

Read the detailed description

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.

03

Conditions studied

  • Diabetic Retinopathy

Browse trials for

Keywords

  • teleophthalmology
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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:

-

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
1,811 participants (actual)

Study 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.

    Other: Online Survey

  • Active comparator
    Clinician Only Testimonials

    Other: Online Survey

  • Active comparator
    Patient Only Testimonials

    Other: Online Survey

  • Active comparator
    National Eye Institute video Control

    Other: Online Survey

  • Active comparator
    Pre-video questionnaire-only Control

    Other: Online Survey

Interventions

  • OtherOnline 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.

06

What researchers measure

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.

    Time frame: 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

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

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan

Time frame: up to 7 years after the completion of the primary outcome

Access criteria: contact study PI for access

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2025 to primary completion in Oct 2026, 16 months.

Of 111 non-industry interventional studies with no phase under Diabetic Retinopathy, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 60. This study's 16 months is below that.

Counting every sponsor, half of 126 studies reached it within 29 months; a quarter within 11 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2024
First posted
Feb 13, 2024
StartActual
May 21, 2025
Primary completionActual
Oct 13, 2026
CompletionActual
Oct 13, 2026
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Nov 5, 2026
Enrollment
1526 (estimated)→1811 (actual)
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Recruiting→Completed
    Enrollment 1526 (estimated)→1811 (actual)
    + 4 other changes: verification date, date precision, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06257082
Responsible party
Sponsor
First posted
Feb 13, 2024
Start date
May 21, 2025
Primary completion
Oct 13, 2026
Completion
Oct 13, 2026
Last update
Nov 5, 2026

Study contacts

Yao Liu, MD, MS
principal investigator · University of Wisconsin, Madison

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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