Trial Outcomes & Findings for Advancing People of Color in Clinical Trials Now: Involvement in Trials Using a Patient-Centered Website: A Community-Engaged Approach (NCT NCT03243071)
NCT ID: NCT03243071
Last Updated: 2022-02-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
Baseline
Results posted on
2022-02-01
Participant Flow
Participant milestones
| Measure |
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.
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
53
|
|
Overall Study
COMPLETED
|
59
|
53
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Advancing People of Color in Clinical Trials Now: Involvement in Trials Using a Patient-Centered Website: A Community-Engaged Approach
Baseline characteristics by cohort
| Measure |
Intervention Group
n=59 Participants
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.
|
Control Group
n=53 Participants
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
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 15.98 • n=5 Participants
|
43 years
STANDARD_DEVIATION 15.03 • n=7 Participants
|
43 years
STANDARD_DEVIATION 15.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
47 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
53 participants
n=7 Participants
|
112 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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).
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.
Outcome measures
| Measure |
Intervention Group (Pair 1)
n=47 Participants
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.
|
Intervention Group (Pair 2)
n=33 Participants
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.
|
Control Group (Pair 3)
n=49 Participants
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).
|
Control Group (Pair 4)
n=25 Participants
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).
|
|---|---|---|---|---|
|
ACTNOW! Clinical Trial Knowledge Assessment Score
|
93.89 score
Standard Deviation 9.98
|
93.58 score
Standard Deviation 9.69
|
94.88 score
Standard Deviation 11.80
|
97.88 score
Standard Deviation 11.45
|
PRIMARY outcome
Timeframe: Month 1Population: 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.
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.
Outcome measures
| Measure |
Intervention Group (Pair 1)
n=47 Participants
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.
|
Intervention Group (Pair 2)
n=49 Participants
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.
|
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).
|
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).
|
|---|---|---|---|---|
|
Clinical Trial Knowledge Assessment Score
|
101.89 score
Standard Deviation 10.37
|
99.67 score
Standard Deviation 10.94
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 326 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.
Outcome measures
| Measure |
Intervention Group (Pair 1)
n=33 Participants
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.
|
Intervention Group (Pair 2)
n=25 Participants
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.
|
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).
|
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).
|
|---|---|---|---|---|
|
Clinical Trial Knowledge Assessment Score
|
98.00 score
Standard Deviation 11.99
|
98.32 score
Standard Deviation 8.46
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: The two arms (intervention and control groups) are further divided into pairs for statistical analysis purposes (paired t-tests).
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.
Outcome measures
| Measure |
Intervention Group (Pair 1)
n=47 Participants
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.
|
Intervention Group (Pair 2)
n=33 Participants
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.
|
Control Group (Pair 3)
n=49 Participants
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).
|
Control Group (Pair 4)
n=25 Participants
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).
|
|---|---|---|---|---|
|
ACTNOW! Self-Efficacy Score
|
10.13 score on a scale
Standard Deviation 4.19
|
10.06 score on a scale
Standard Deviation 4.49
|
11.16 score on a scale
Standard Deviation 3.08
|
11.04 score on a scale
Standard Deviation 3.08
|
PRIMARY outcome
Timeframe: Month 1A 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.
Outcome measures
| Measure |
Intervention Group (Pair 1)
n=47 Participants
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.
|
Intervention Group (Pair 2)
n=49 Participants
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.
|
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).
|
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).
|
|---|---|---|---|---|
|
Self-Efficacy Score
|
12.06 score on a scale
Standard Deviation 3.35
|
12.02 score on a scale
Standard Deviation 3.40
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 3Population: 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.
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.
Outcome measures
| Measure |
Intervention Group (Pair 1)
n=33 Participants
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.
|
Intervention Group (Pair 2)
n=25 Participants
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.
|
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).
|
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).
|
|---|---|---|---|---|
|
Self-Efficacy Score
|
12.42 score on a scale
Standard Deviation 3.40
|
11.88 score on a scale
Standard Deviation 3.10
|
—
|
—
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place