- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT06257082
Videobaserad patientutbildningsintervention för diabetisk ögonscreening i Latinx-samhällen
Utveckling av en kulturellt anpassad, videobaserad patientutbildningsinsats för att öka diabetisk ögonscreening och teleoftalmologi i Latinx-samhällen
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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Yao Liu, MD, MS
- Telefonnummer: 608-263-1481
- E-post: yao.liu2@wisc.edu
Studera Kontakt Backup
- Namn: Cinthya Maldonado
- Telefonnummer: 608-265-5777
- E-post: cmaldonado5@wisc.edu
Studieorter
-
-
Wisconsin
-
Madison, Wisconsin, Förenta staterna, 53792
- Rekrytering
- UW Hospital and Clinics
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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:
-
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Rekommendationer endast för läkare
|
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. |
|
Aktiv komparator: Rekommendationer endast för patient
|
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. |
|
Aktiv komparator: National Eye Institute videokontroll
|
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. |
|
Aktiv komparator: Kontroll för enbart frågeformulär före video
|
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. |
|
Aktiv komparator: Patient plus Clinician Combined Testimonials
In addition to being randomized for online survey participants, focus groups will view patient plus clinician combined testimonials. |
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Eye Health Literacy as measured by Compliance with Annual Diabetic Eye Exams Survey (CADEES)
Tidsram: pre and post video testimonial intervention (up to 90 minutes)
|
CADEES is scored from 1-5 where higher scores indicate increase eye health literacy. |
pre and post video testimonial intervention (up to 90 minutes)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Trust in Healthcare as measured by Trust in the Health Care Team (T-HCT) scale score
Tidsram: pre and post video testimonial intervention (up to 90 minutes)
|
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)
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Yao Liu, MD, MS, University of Wisconsin, Madison
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2024-1566
- A536000 (Annan identifierare: UW Madison)
- 1UG1EY032446-01 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Tidsram för IPD-delning
up to 7 years after the completion of the primary outcome
Kriterier för IPD Sharing Access
contact study PI for access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
Läkemedels- och apparatinformation, studiedokument
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