RecruitmentACT NowNCT03243071

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

A study testing Tailored Website and Standard Website in people with Recruitment, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Recruitment
What is being tested?: Tailored Website and Standard Website
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 112 participants
Where: 1 siteUnited States
Study dates: 14 Aug 2017to 28 Apr 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

New York University School of Medicine
New York, New York, 10016

Other trials in United States

About this study

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.

Read the detailed description

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: Recruitment
Being tested: Tailored Website, Standard Website
Keywords: Medical Care, Racial Discrimination, Poor Health Literacy, Medical Care Disparities
Medical subject headings: Racism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tailored WebsiteBehavioural
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.
Standard WebsiteBehavioural
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).

Study groups in NCT03243071
Study group	Role	What they receive
Intervention Group	Experimental	The intervention group will have access to culturally tailored website. Receives: Behavioral: Tailored Website
Control Group	Active comparator	Participants in the control group will have access to NYU 's standard trial participation website. Receives: Behavioral: Standard Website

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Aug 201728 Apr 2019

First posted8 Aug 2017
Study start14 Aug 2017
Primary completion28 Jan 2019
Study completion28 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for RecruitmentStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03243071
Sponsor's protocol ID: 17-00170
Acronym: ACT Now
Status last verified: Jan 2022
First submitted: 2 Aug 2017
Last updated: 1 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 32673274

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Advancing People of Color in Clinical Trials Now: Involvement in Trials Using a Patient-Centered Website: A Community-Engaged Approach
ClinicalTrials.gov ID: NCT03243071
Acronym / sponsor ID: ACT Now / 17-00170
Conditions: Recruitment
Keywords: Medical Care, Racial Discrimination, Poor Health Literacy, Medical Care Disparities
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Study start: 14 Aug 2017 (actual)
Primary completion: 28 Jan 2019 (actual)
Study completion: 28 Apr 2019 (actual)
First posted: 8 Aug 2017 (actual)
Results: Posted 1 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention Group	Experimental	Behavioral: Tailored WebsiteThe intervention group will have access to culturally tailored website.
Control Group	Active comparator	Behavioral: Standard WebsiteParticipants in the control group will have access to NYU 's standard trial participation website.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tailored WebsiteParticipants 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.	Behavioural	Intervention Group
Standard WebsiteParticipants 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).	Behavioural	Control Group

Primary outcome

ACTNOW! Clinical Trial Knowledge Assessment Score
Time frame: Baseline
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.
Clinical Trial Knowledge Assessment Score
Time frame: 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.
Clinical Trial Knowledge Assessment Score
Time frame: 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.
ACTNOW! Self-Efficacy Score
Time frame: Baseline
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.
Self-Efficacy Score
Time frame: Month 1
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.
Self-Efficacy Score
Time frame: 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.

Results and safety

Results posted to the registry on 1 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Group	59	59
Control Group	53	53

Primary outcome: ACTNOW! Clinical Trial Knowledge Assessment Score

Time frame: Baseline. Mean (Standard Deviation). Unit: score

Measure	Intervention Group (Pair 1) n = 47	Intervention Group (Pair 2) n = 33	Control Group (Pair 3) n = 49	Control Group (Pair 4) n = 25
Value	93.89 (9.98)	93.58 (9.69)	94.88 (11.80)	97.88 (11.45)

Population analysed: The discrepancy in overall number of participants analyzed with numbers provided in the participant flow module lies with over enrollment of study subjects to account for attrition loss and analysis only being done for those participants who had complete data. The two arms (intervention and control groups) are further divided into pairs for statistical analysis purposes (paired t-tests).

Primary outcome: Clinical Trial Knowledge Assessment Score

Time frame: Month 1. Mean (Standard Deviation). Unit: score

Measure	Intervention Group (Pair 1) n = 47	Control Group (Pair 3) n = 49
Value	101.89 (10.37)	99.67 (10.94)

Primary outcome: Clinical Trial Knowledge Assessment Score

Time frame: Month 3. Mean (Standard Deviation). Unit: score

Measure	Intervention Group (Pair 2) n = 33	Control Group (Pair 4) n = 25
Value	98.00 (11.99)	98.32 (8.46)

Primary outcome: ACTNOW! Self-Efficacy Score

Time frame: Baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Intervention Group (Pair 1) n = 47	Intervention Group (Pair 2) n = 33	Control Group (Pair 3) n = 49	Control Group (Pair 4) n = 25
Value	10.13 (4.19)	10.06 (4.49)	11.16 (3.08)	11.04 (3.08)

Population analysed: The two arms (intervention and control groups) are further divided into pairs for statistical analysis purposes (paired t-tests).

Adverse events

Time frame: 3 Months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Group	0 of 59 (0%)	0 of 59 (0%)	0 of 59
Control Group	0 of 53 (0%)	0 of 53 (0%)	0 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32673274Chung 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.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Girardin Jean-Louis, Ph.D. principal investigator

NYU Langone Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Tailored Website and Standard Website in people with Recruitment, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ACTNOW! Clinical Trial Knowledge Assessment Score (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03243071, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.