Advancing People of Color in Clinical Trials Now: Involvement in Trials Using a Patient-Centered Website: A Community-Engaged Approach

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-14

Study Completion Date

2019-04-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Inclusion Appeal Videos and Intent to Register for Pediatric Clinical Trials

NCT06138145

Patient Participation Pediatric ALL

COMPLETED NA

Willingness to Participate in Clinical Trials Among Black and African Americans

NCT04938895

Researcher-Subject Relations

COMPLETED NA

Increasing Minority Participation in Clinical Trials

NCT02600533

Clinical Trial

COMPLETED NA

Patient Navigator PRE-ACT Educational Intervention to Promote Decision Making Among Minorities

NCT05701085

Educational Intervention Minorities

RECRUITING NA

CKD Awareness, Referrals, Education, and Support Intervention for Early-Stage CKD

NCT07210710

Chronic Kidney Disease Diabetes

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Recruitment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Group

The intervention group will have access to culturally tailored website.

Group Type EXPERIMENTAL

Tailored Website

Intervention Type BEHAVIORAL

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.

Control Group

Participants in the control group will have access to NYU 's standard trial participation website.

Group Type ACTIVE_COMPARATOR

Standard Website

Intervention Type BEHAVIORAL

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tailored Website

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.

Intervention Type BEHAVIORAL

Standard 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).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes