- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT06257082
Videopohjainen potilaskoulutus interventio diabeettisten silmien seulontaa varten Latinx-yhteisöissä
Kulttuurisesti mukautetun, videopohjaisen potilaskoulutustoimenpiteen kehittäminen diabeettisen näönseulonnan ja teleoftalmologian käytön lisäämiseksi latinalaisyhteisöissä
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.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Wisconsin
-
Madison, Wisconsin, Yhdysvallat, 53792
- UW Hospital and Clinics
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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:
-
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: Vain lääkärin suositukset
|
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: Vain potilaiden suosittelut
|
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 -videonhallinta
|
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: Vain kyselyä edeltävä hallinta
|
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 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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Eye Health Literacy as measured by Compliance with Annual Diabetic Eye Exams Survey (CADEES)
Aikaikkuna: 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)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Trust in Healthcare as measured by Trust in the Health Care Team (T-HCT) scale score
Aikaikkuna: 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)
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Yao Liu, MD, MS, University of Wisconsin, Madison
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 2024-1566
- A536000 (Muu tunniste: UW Madison)
- 1UG1EY032446-01 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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-jaon aikakehys
up to 7 years after the completion of the primary outcome
IPD-jaon käyttöoikeuskriteerit
contact study PI for access
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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