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临床试验/NCT06257082
NCT06257082招募中不适用

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

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 1,526 人开始时间: 2025年5月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,526
试验地点
2
主要终点
Change in Eye Health Literacy as measured by Compliance with Annual Diabetic Eye Exams Survey (CADEES)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (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

排除标准

  • 未提供

研究组 & 干预措施

National Eye Institute video Control

Active Comparator

干预措施: Online Survey (Other)

Pre-video questionnaire-only Control

Active Comparator

干预措施: Online Survey (Other)

Patient Only Testimonials

Active Comparator

干预措施: Online Survey (Other)

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.

干预措施: Online Survey (Other)

Clinician Only Testimonials

Active Comparator

干预措施: Online Survey (Other)

结局指标

主要结局

Change in Eye Health Literacy as measured by Compliance with Annual Diabetic Eye Exams Survey (CADEES)

时间窗: pre and post video testimonial intervention (up to 90 minutes)

CADEES is scored from 1-5 where higher scores indicate increase eye health literacy.

次要结局

  • Change in Trust in Healthcare as measured by Trust in the Health Care Team (T-HCT) scale score(pre and post video testimonial intervention (up to 90 minutes))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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