Recruitment
Conditions
Keywords
Medical Care, Racial Discrimination, Poor Health Literacy, Medical Care Disparities
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.
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.
Interventions
BEHAVIORALTailored 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.
BEHAVIORALStandard 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).
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 59 |
| 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). | 53 |
| Total | 112 |
Baseline characteristics
| Characteristic | Intervention Group | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 15.98 | 43 years STANDARD_DEVIATION 15.74 | 43 years STANDARD_DEVIATION 15.03 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 9 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 47 Participants | 83 Participants | 36 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 20 Participants | 10 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 59 participants | 112 participants | 53 participants |
| Sex: Female, Male Female | 46 Participants | 73 Participants | 27 Participants |
| Sex: Female, Male Male | 13 Participants | 39 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 53 |
| other Total, other adverse events | 0 / 59 | 0 / 53 |
| serious Total, serious adverse events | 0 / 59 | 0 / 53 |
Outcome results
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.
Time frame: Baseline
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (Pair 1) | ACTNOW! Clinical Trial Knowledge Assessment Score | 93.89 score | Standard Deviation 9.98 |
| Intervention Group (Pair 2) | ACTNOW! Clinical Trial Knowledge Assessment Score | 93.58 score | Standard Deviation 9.69 |
| Control Group (Pair 3) | ACTNOW! Clinical Trial Knowledge Assessment Score | 94.88 score | Standard Deviation 11.8 |
| Control Group (Pair 4) | ACTNOW! Clinical Trial Knowledge Assessment Score | 97.88 score | Standard Deviation 11.45 |
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.
Time frame: Baseline
Population: The two arms (intervention and control groups) are further divided into pairs for statistical analysis purposes (paired t-tests).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (Pair 1) | ACTNOW! Self-Efficacy Score | 10.13 score on a scale | Standard Deviation 4.19 |
| Intervention Group (Pair 2) | ACTNOW! Self-Efficacy Score | 10.06 score on a scale | Standard Deviation 4.49 |
| Control Group (Pair 3) | ACTNOW! Self-Efficacy Score | 11.16 score on a scale | Standard Deviation 3.08 |
| Control Group (Pair 4) | ACTNOW! Self-Efficacy Score | 11.04 score on a scale | Standard Deviation 3.08 |
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.
Time frame: Month 1
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (Pair 1) | Clinical Trial Knowledge Assessment Score | 101.89 score | Standard Deviation 10.37 |
| Intervention Group (Pair 2) | Clinical Trial Knowledge Assessment Score | 99.67 score | Standard Deviation 10.94 |
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.
Time frame: Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (Pair 1) | Clinical Trial Knowledge Assessment Score | 98.00 score | Standard Deviation 11.99 |
| Intervention Group (Pair 2) | Clinical Trial Knowledge Assessment Score | 98.32 score | Standard Deviation 8.46 |
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.
Time frame: Month 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (Pair 1) | Self-Efficacy Score | 12.06 score on a scale | Standard Deviation 3.35 |
| Intervention Group (Pair 2) | Self-Efficacy Score | 12.02 score on a scale | Standard Deviation 3.4 |
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.
Time frame: Month 3
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (Pair 1) | Self-Efficacy Score | 12.42 score on a scale | Standard Deviation 3.4 |
| Intervention Group (Pair 2) | Self-Efficacy Score | 11.88 score on a scale | Standard Deviation 3.1 |