ACT Now: Advancing People of Color in Clinical Trials Now: Involvement in Trials Using a Patient-Centered Website: A Community-Engaged Approach
Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT03243071
Collaborator
(none)
112
1
2
20.4
5.5
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
112 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Advancing People of Color in Clinical Trials Now: Involvement in Trials Using a Patient-Centered Website: A Community-Engaged Approach
Actual Study Start Date
:
Aug 14, 2017
Actual Primary Completion Date
:
Jan 28, 2019
Actual Study Completion Date
:
Apr 28, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Group The intervention group will have access to culturally tailored website. |
Behavioral: 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.
|
| Active Comparator: Control Group Participants in the control group will have access to NYU 's standard trial participation website. |
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).
|
Outcome Measures
Primary Outcome Measures
- ACTNOW! Clinical Trial Knowledge Assessment Score [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 [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 [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 [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 [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 [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New York University School of Medicine | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
Investigators
- Principal Investigator: Girardin Jean-Louis, Ph.D., NYU Langone Health
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT03243071
Other Study ID Numbers:
- 17-00170
First Posted:
Aug 8, 2017
Last Update Posted:
Feb 1, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by NYU Langone Health
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Intervention Group | Control Group |
|---|---|---|
| Arm/Group Description | The intervention group will have access to culturally tailored website. 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. | Participants in the control group will have access to NYU 's standard trial participation website. 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). |
| Period Title: Overall Study | ||
| STARTED | 59 | 53 |
| COMPLETED | 59 | 53 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Intervention Group | Control Group | Total |
|---|---|---|---|
| Arm/Group Description | The intervention group (n=50) will have access to culturally tailored website. 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. | Participants in the control group (n=50) will have access to NYU 's standard trial participation website. 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). | Total of all reporting groups |
| Overall Participants | 59 | 53 | 112 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
43
(15.98)
|
43
(15.03)
|
43
(15.74)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
46
78%
|
27
50.9%
|
73
65.2%
|
| Male |
13
22%
|
26
49.1%
|
39
34.8%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
2
3.4%
|
7
13.2%
|
9
8%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
47
79.7%
|
36
67.9%
|
83
74.1%
|
| White |
0
0%
|
0
0%
|
0
0%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
10
16.9%
|
10
18.9%
|
20
17.9%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
59
100%
|
53
100%
|
112
100%
|
Outcome Measures
| Title | ACTNOW! Clinical Trial Knowledge Assessment Score |
|---|---|
| Description | 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. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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). |
| Arm/Group Title | Intervention Group (Pair 1) | Intervention Group (Pair 2) | Control Group (Pair 3) | Control Group (Pair 4) |
|---|---|---|---|---|
| Arm/Group Description | The intervention group will have access to culturally tailored website. 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. | The intervention group will have access to culturally tailored website. 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. | Participants in the control group will have access to NYU 's standard trial participation website. 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). | Participants in the control group will have access to NYU 's standard trial participation website. 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). |
| Measure Participants | 47 | 33 | 49 | 25 |
| Mean (Standard Deviation) [score] |
93.89
(9.98)
|
93.58
(9.69)
|
94.88
(11.80)
|
97.88
(11.45)
|
| Title | Clinical Trial Knowledge Assessment Score |
|---|---|
| Description | 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. |
| Time Frame | Month 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Intervention Group (Pair 1) | Control Group (Pair 3) |
|---|---|---|
| Arm/Group Description | The intervention group will have access to culturally tailored website. 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. | Participants in the control group will have access to NYU 's standard trial participation website. 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). |
| Measure Participants | 47 | 49 |
| Mean (Standard Deviation) [score] |
101.89
(10.37)
|
99.67
(10.94)
|
| Title | Clinical Trial Knowledge Assessment Score |
|---|---|
| Description | 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. |
| Time Frame | Month 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Intervention Group (Pair 2) | Control Group (Pair 4) |
|---|---|---|
| Arm/Group Description | The intervention group will have access to culturally tailored website. 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. | Participants in the control group will have access to NYU 's standard trial participation website. 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). |
| Measure Participants | 33 | 25 |
| Mean (Standard Deviation) [score] |
98.00
(11.99)
|
98.32
(8.46)
|
| Title | ACTNOW! Self-Efficacy Score |
|---|---|
| Description | 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. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| The two arms (intervention and control groups) are further divided into pairs for statistical analysis purposes (paired t-tests). |
| Arm/Group Title | Intervention Group (Pair 1) | Intervention Group (Pair 2) | Control Group (Pair 3) | Control Group (Pair 4) |
|---|---|---|---|---|
| Arm/Group Description | The intervention group will have access to culturally tailored website. 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. | The intervention group will have access to culturally tailored website. 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. | Participants in the control group (n=50) will have access to NYU 's standard trial participation website. 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). | Participants in the control group will have access to NYU 's standard trial participation website. 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). |
| Measure Participants | 47 | 33 | 49 | 25 |
| Mean (Standard Deviation) [score on a scale] |
10.13
(4.19)
|
10.06
(4.49)
|
11.16
(3.08)
|
11.04
(3.08)
|
| Title | Self-Efficacy Score |
|---|---|
| Description | 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. |
| Time Frame | Month 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Intervention Group (Pair 1) | Control Group (Pair 3) |
|---|---|---|
| Arm/Group Description | The intervention group will have access to culturally tailored website. 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. | Participants in the control group will have access to NYU 's standard trial participation website. 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). |
| Measure Participants | 47 | 49 |
| Mean (Standard Deviation) [score on a scale] |
12.06
(3.35)
|
12.02
(3.40)
|
| Title | Self-Efficacy Score |
|---|---|
| Description | 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. |
| Time Frame | Month 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Intervention Group (Pair 2) | Control Group (Pair 4) |
|---|---|---|
| Arm/Group Description | The intervention group will have access to culturally tailored website. 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. | Participants in the control group will have access to NYU 's standard trial participation website. 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). |
| Measure Participants | 33 | 25 |
| Mean (Standard Deviation) [score on a scale] |
12.42
(3.40)
|
11.88
(3.10)
|
Adverse Events
| Time Frame | 3 Months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Intervention Group | Control Group | ||
| Arm/Group Description | The intervention group will have access to culturally tailored website. 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. | Participants in the control group will have access to NYU 's standard trial participation website. 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). | ||
All Cause Mortality |
||||
| Intervention Group | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/59 (0%) | 0/53 (0%) | ||
Serious Adverse Events |
||||
| Intervention Group | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/59 (0%) | 0/53 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Intervention Group | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/59 (0%) | 0/53 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Girardin Jean-Louis, PhD |
|---|---|
| Organization | NYU Langoen Health |
| Phone | 646-501-3431 |
| Girardin.Jean-Louis@nyulangone.org |
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT03243071
Other Study ID Numbers:
- 17-00170
First Posted:
Aug 8, 2017
Last Update Posted:
Feb 1, 2022
Last Verified:
Jan 1, 2022