- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06257082
Videobasert pasientopplæringsintervensjon for diabetisk øyescreening i Latinx-samfunn
Utvikling av en kulturtilpasset, videobasert pasientopplæringsintervensjon for å øke diabetisk øyescreening og bruk av teleoftalmologi i latinske samfunn
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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Yao Liu, MD, MS
- Telefonnummer: 608-263-1481
- E-post: yao.liu2@wisc.edu
Studer Kontakt Backup
- Navn: Cinthya Maldonado
- Telefonnummer: 608-265-5777
- E-post: cmaldonado5@wisc.edu
Studiesteder
-
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Wisconsin
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Madison, Wisconsin, Forente stater, 53792
- Rekruttering
- UW Hospital and Clinics
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Kun klinikere attester
|
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. |
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Aktiv komparator: Kun pasientuttalelser
|
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. |
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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. |
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Aktiv komparator: Kun kontroll før video spørreskjema
|
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Eye Health Literacy as measured by Compliance with Annual Diabetic Eye Exams Survey (CADEES)
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Trust in Healthcare as measured by Trust in the Health Care Team (T-HCT) scale score
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Yao Liu, MD, MS, University of Wisconsin, Madison
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2024-1566
- A536000 (Annen identifikator: UW Madison)
- 1UG1EY032446-01 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
up to 7 years after the completion of the primary outcome
Tilgangskriterier for IPD-deling
contact study PI for access
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
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