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

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06257082
• Other study ID #: I-TRUST: Video-based
• Secondary ID: A5360001UG1EY032
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: September 2025

Study information

• Verified date: February 2024
• Source: University of Wisconsin, Madison
• Contact: Cinthya Maldonado
• Phone: 608-265-5777
• Email: cmaldonado5[@]wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1526
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Diabetic Retinopathy

Intervention

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.

Locations

Country	Name	City	State
United States	UW Hospital and Clinics	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	pre and post video testimonial intervention (up to 90 minutes)
Secondary	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.	pre and post video testimonial intervention (up to 90 minutes)

External Links

•   A Guide to Implementation for Sustained Impact in Teleophthalmology (I-SITE)
•   Implementation of Teleophthalmology in Urban Health Systems Study