Advancing People of Color in Clinical Trials Now: Involvement in Trials Using a Patient-Centered Website: A Community-Engaged Approach (ACT Now)
28. januar 2022 opdateret af: NYU Langone Health
The purpose pf this study is to evaluate the comparative effectiveness of a culturally and linguistically tailored clinical trial literacy website in increasing likelihood of participating in clinical trials.
To achieve this objective,a randomized group design will address the following patient-centered outcomes: willingness to enroll in clinical trials and behavioral intent as well as likelihood of referring others to enroll in such trials) before and after exposure to a culturally-tailored clinical trial literacy website.
Health literacy will be measured both before and post exposure to tailored messages.
Participants will be randomized into two groups.
The intervention group (n=50) will have access to culturally tailored website.
Participants in the control group (n=50) will have access to NYU 's standard trial participation website.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Compelling evidence demonstrates racial/ethnic disparities in health and healthcare in the United States.
These disparities arise from various factors including unequal access to adequate medical care, perceived racial discrimination, and poor health literacy.The Center for Healthful Behavior Change (CHBC) has been involved in numerous initiatives to eradicate health disparities and have implemented NIH-funded interventions to address inequities in health.
Interventions targeting patient-centered outcomes have been suboptimal because of inadequate infrastructure to support equitable contributions from stakeholders (patients, providers, and community leaders) in all aspects of the research process.
This is crucial to promote sustainable effects regarding minority patients' ability to make informed decisions about participating in existing clinical trials.
This study will address this gap, bringing together academic investigators and important stakeholders to develop a website providing access to culturally tailored videos to enhance awareness of clinical trial, health literacy, thus promoting participation in existing clinical trials.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
112
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New York
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New York, New York, Forenede Stater, 10016
- New York University School of Medicine
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Self-reported race/ethnicity as African American, African, Caribbean American or black men and women
- accessible by telephone
- no plans to move away from the region within the year following enrollment; consent to participate.
Exclusion Criteria:
- Progressive medical illness in which disability or death is expected within one year
- impaired cognitive or functional ability, which would preclude meaningful participation in the study
- stated intention to move within the same year of enrollment.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Intervention Group
The intervention group will have access to culturally tailored website.
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Participants randomized to the intervention arm will have free access to a password protected interactive culturally and linguistically tailored website via a tablet device.
No private identifiable data about you will be collected.
Participants will receive a brief 10-minute tutorial by a trained research assistant on login procedures and use of the website.
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Aktiv komparator: Control Group
Participants in the control group will have access to NYU 's standard trial participation website.
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Participants randomized to the control condition will have free access to the NYU standard clinical trials website.
Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of enrollment).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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ACTNOW! Clinical Trial Knowledge Assessment Score
Tidsramme: Baseline
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26 statements involved in assessing the participants' knowledge of clinical trials.
The total range of score is 0-104; the higher the score, the higher the level of knowledge.
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Baseline
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Clinical Trial Knowledge Assessment Score
Tidsramme: Month 1
|
26 statements involved in assessing the participants' knowledge of clinical trials.
The total range of score is 0-104; the higher the score, the higher the level of knowledge.
|
Month 1
|
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Clinical Trial Knowledge Assessment Score
Tidsramme: Month 3
|
26 statements involved in assessing the participants' knowledge of clinical trials.
The total range of score is 0-104; the higher the score, the higher the level of knowledge.
|
Month 3
|
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ACTNOW! Self-Efficacy Score
Tidsramme: Baseline
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A 4-item perceived effectiveness scale was used to assess the perceived persuasiveness of the message.
The total range of score is 0-16; the higher the score, the higher the level of self-efficacy.
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Baseline
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Self-Efficacy Score
Tidsramme: Month 1
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A 4-item perceived effectiveness scale, adapted from Fishbein et al. (2002) was used to assess the perceived persuasiveness of the message.
The total range of score is 0-16; the higher the score, the higher the level of self-efficacy.
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Month 1
|
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Self-Efficacy Score
Tidsramme: Month 3
|
A 4-item perceived effectiveness scale, adapted from Fishbein et al. (2002) was used to assess the perceived persuasiveness of the message.
The total range of score is 0-16; the higher the score, the higher the level of self-efficacy.
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Month 3
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Girardin Jean-Louis, Ph.D., NYU Langone Health
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. august 2017
Primær færdiggørelse (Faktiske)
28. januar 2019
Studieafslutning (Faktiske)
28. april 2019
Datoer for studieregistrering
Først indsendt
2. august 2017
Først indsendt, der opfyldte QC-kriterier
7. august 2017
Først opslået (Faktiske)
8. august 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. februar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. januar 2022
Sidst verificeret
1. januar 2022
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 17-00170
Plan for individuelle deltagerdata (IPD)
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Uafklaret
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Tailored Website
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Duke UniversityNational Institute of Mental Health (NIMH)AfsluttetSkizofrenispektrum og andre psykotiske lidelser | Psykiske lidelser, alvorligeTanzania