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Recruiting NCT06257082

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

No phase Interventional Diabetic Retinopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Online Survey.
Who it may be relevant to
Registry conditions: Diabetic Retinopathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

  • 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)]
Secondary outcome measures (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)]

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

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

United States · 1 center
  • UW Hospital and Clinics — Madison

Identifiers

NCT: NCT06257082 · 2024-1566 · A536000 · 1UG1EY032446-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗