Diabetic RetinopathyNCT06257082
Video-based Patient Education Intervention for Diabetic Eye Screening in Latinx Communities
A study testing Online Survey in people with Diabetic Retinopathy, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Online Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,811 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2025to 13 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Culturally Adapted, Video-based Patient Education Intervention to Increase Diabetic Eye Screening and Teleophthalmology Use 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.
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.
- Conditions
- Diabetic Retinopathy
- Being tested
- Online Survey
- Keywords
- teleophthalmology
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online SurveyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Online Survey |
| Clinician Only Testimonials | Active comparator | Not described Receives: Other: Online Survey |
| Patient Only Testimonials | Active comparator | Not described Receives: Other: Online Survey |
| National Eye Institute video Control | Active comparator | Not described Receives: Other: Online Survey |
| Pre-video questionnaire-only Control | Active comparator | Not described Receives: Other: Online Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: pre and post video testimonial intervention (up to 90 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start21 May 2025
- Primary completion13 Oct 2026
- Study completion13 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,811 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Yao Liu, MD, MS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257082
- Sponsor's protocol ID
- 2024-1566
- Other IDs
- A536000, 1UG1EY032446-01
- Status last verified
- Nov 2026
- First submitted
- 5 Feb 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Culturally Adapted, Video-based Patient Education Intervention to Increase Diabetic Eye Screening and Teleophthalmology Use in Latinx Communities
- ClinicalTrials.gov ID
- NCT06257082
- Acronym / sponsor ID
- 2024-1566
- Conditions
- Diabetic Retinopathy
- Keywords
- teleophthalmology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,811 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 21 May 2025 (actual)
- Primary completion
- 13 Oct 2026 (actual)
- Study completion
- 13 Oct 2026 (actual)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Patient plus Clinician Combined Testimonials | Active comparator | Other: Online SurveyIn addition to being randomized for online survey participants, focus groups will view patient plus clinician combined testimonials. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online SurveyParticipants 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. | Other | Clinician Only Testimonials, National Eye Institute video Control, Patient Only Testimonials, Patient plus Clinician Combined Testimonials, Pre-video questionnaire-only Control |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- A Guide to Implementation for Sustained Impact in Teleophthalmology (I-SITE)Link provided by the sponsor.
- Implementation of Teleophthalmology in Urban Health Systems StudyLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Diabetic Retinopathy
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
Recruiting
To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity. Assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists
Proliferative Diabetic Retinopathy (PDR)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yao Liu, MD, MS principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Survey in people with Diabetic Retinopathy, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.