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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | The intervention group will have access to culturally tailored website. |
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| Control Group | Active Comparator | Participants in the control group will have access to NYU 's standard trial participation website. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored Website | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Girardin Jean-Louis, Ph.D. | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32673274 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | 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. |
| FG001 | Control Group | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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). | Posted | Mean | Standard Deviation | score | Baseline |
|
3 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Girardin Jean-Louis, PhD | NYU Langoen Health | 646-501-3431 | Girardin.Jean-Louis@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 5, 2018 | Sep 21, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D063505 | Racism |
| ID | Term |
|---|---|
| D011287 | Prejudice |
| D012919 | Social Behavior |
| D001519 | Behavior |
| D063508 | Social Discrimination |
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|
| Standard Website | 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). |
|
| Month 3 |
| BG001 | Control Group | 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). |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Intervention Group (Pair 2) | 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. |
| OG002 | Control Group (Pair 3) | 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). |
| OG003 | Control Group (Pair 4) | 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). |
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | score | Month 1 |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score | Month 3 |
|
|
|
| Primary | 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. | The two arms (intervention and control groups) are further divided into pairs for statistical analysis purposes (paired t-tests). | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 1 |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
|
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| 0 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | Control Group | 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). | 0 | 53 | 0 | 53 | 0 | 53 |
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