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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: Other: Online Survey

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 Type: Interventional
• Enrollment (Estimated): 1526
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yao Liu, MD, MS; Phone Number: 608-263-1481; Email: yao.liu2@wisc.edu
• Study Contact Backup: Name: Cinthya Maldonado; Phone Number: 608-265-5777; Email: cmaldonado5@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • UW Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
Active Comparator: Clinician Only Testimonials	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.
Active Comparator: Patient Only Testimonials	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.
Active Comparator: National Eye Institute video Control	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.
Active Comparator: Pre-video questionnaire-only Control	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Eye Institute (NEI)
• Investigators: Principal Investigator: Yao Liu, MD, MS, University of Wisconsin, Madison

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Estimated): February 13, 2024

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: teleophthalmology
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: I-TRUST: Video-based; A536000 (Other Identifier: UW- Madison); 1UG1EY032446-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: up to 7 years after the completion of the primary outcome
• IPD Sharing Access Criteria: contact study PI for access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No