N/A
N=112
Advancing People of Color in Clinical Trials Now: Involvement in Trials Using a Patient-Centered Website: A Community-Engaged Approach
Recruitment
Bottom Line
View on ClinicalTrials.gov: NCT03243071 ↗Enrolled (actual)
112
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: ACTNOW! Clinical Trial Knowledge Assessment Score — 93.89; 93.58; 94.88; 97.88 score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tailored Website (Behavioral); Standard Website (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ACTNOW! Clinical Trial Knowledge Assessment Score |
93.89; 93.58; 94.88; 97.88 | — |
| PRIMARY Clinical Trial Knowledge Assessment Score |
98.00; 98.32 | — |
| PRIMARY Clinical Trial Knowledge Assessment Score |
98.00; 98.32 | — |
| PRIMARY ACTNOW! Self-Efficacy Score |
10.13; 10.06; 11.16; 11.04 | — |
| PRIMARY Self-Efficacy Score |
12.42; 11.88 | — |
| PRIMARY Self-Efficacy Score |
12.42; 11.88 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03243071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.