Advancing People of Color in Clinical Trials Now: Involvement in Trials Using a Patient-Centered Website: A Community-Engaged Approach
ACT Now
1 other identifier
interventional
112
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2017
CompletedFirst Posted
Study publicly available on registry
August 8, 2017
CompletedStudy Start
First participant enrolled
August 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2019
CompletedResults Posted
Study results publicly available
February 1, 2022
CompletedFebruary 1, 2022
January 1, 2022
1.5 years
August 2, 2017
September 27, 2021
January 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
ACTNOW! Clinical Trial Knowledge Assessment Score
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.
Baseline
Clinical Trial Knowledge Assessment Score
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
Clinical Trial Knowledge Assessment Score
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
ACTNOW! Self-Efficacy Score
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.
Baseline
Self-Efficacy Score
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.
Month 1
Self-Efficacy Score
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.
Month 3
Study Arms (2)
Intervention Group
EXPERIMENTALThe intervention group will have access to culturally tailored website.
Control Group
ACTIVE COMPARATORParticipants in the control group will have access to NYU 's standard trial participation website.
Interventions
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.
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
Related Publications (1)
Chung A, Seixas A, Williams N, Senathirajah Y, Robbins R, Newsome Garcia V, Ravenell J, Jean-Louis G. Development of "Advancing People of Color in Clinical Trials Now!": Web-Based Randomized Controlled Trial Protocol. JMIR Res Protoc. 2020 Jul 14;9(7):e17589. doi: 10.2196/17589.
PMID: 32673274DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Girardin Jean-Louis, PhD
- Organization
- NYU Langoen Health
Study Officials
- PRINCIPAL INVESTIGATOR
Girardin Jean-Louis, Ph.D.
NYU Langone Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2017
First Posted
August 8, 2017
Study Start
August 14, 2017
Primary Completion
January 28, 2019
Study Completion
April 28, 2019
Last Updated
February 1, 2022
Results First Posted
February 1, 2022
Record last verified: 2022-01