Trial Outcomes & Findings for A Sociolinguistic-enabled Web Application to Develop Precision Health Intervention for African Americans (NCT NCT04705363)

NCT ID: NCT04705363

Last Updated: 2025-04-18

Results Overview

Measure: Intention to talk to a doctor about colorectal cancer screening. Construct: Behavioral intention to communicate Item: The virtual appointment made me want to discuss colon cancer screening options with my doctor. Participants will respond using three 5-point Likert scales that will be summed. The total score ranges from 3 to 15, with higher scores indicating a greater intention to discuss colorectal cancer screening with a healthcare professional. Mean scores closer to 3 reflect lower intention, while mean scores closer to 15 reflect higher intention.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

751 participants

Primary outcome timeframe

Immediately after the intervention, up to 1 hour

Results posted on

2025-04-18

Participant Flow

Participant milestones

Participant milestones
Measure
Text-only
A virtual health assistant that will consist of photos of the computer-generated doctor with text that will guide participants through the interaction. No voice will accompany the photos or text. Text-only: virtual health assistant that will consist of photos of the computer-generated doctor with text that will guide participants through the interaction. No voice will accompany the photos or text.
High Dialectal
A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used high dialectal variation that will guide participants through the interaction. High Dialectal: A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used high dialectal variation that will guide participants through the interaction.
Low Dialectal
A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used low dialectal variation that will guide participants through the interaction. Low Dialectal: A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used low dialectal variation that will guide participants through the interaction.
Non-Dialectal
A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used no dialectal variation that will guide participants through the interaction. Non-Dialectal: A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used no dialectal variation that will guide participants through the interaction.
Overall Study
STARTED
107
214
212
218
Overall Study
COMPLETED
107
214
212
218
Overall Study
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Sociolinguistic-enabled Web Application to Develop Precision Health Intervention for African Americans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Text-only
n=107 Participants
A virtual health assistant that will consist of photos of the computer-generated doctor with text that will guide participants through the interaction. No voice will accompany the photos or text. Text-only: virtual health assistant that will consist of photos of the computer-generated doctor with text that will guide participants through the interaction. No voice will accompany the photos or text.
High Dialectal
n=214 Participants
A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used high dialectal variation that will guide participants through the interaction. High Dialectal: A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used high dialectal variation that will guide participants through the interaction.
Low Dialectal
n=212 Participants
A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used low dialectal variation that will guide participants through the interaction. Low Dialectal: A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used low dialectal variation that will guide participants through the interaction.
Non-Dialectal
n=218 Participants
A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used no dialectal variation that will guide participants through the interaction. Non-Dialectal: A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used no dialectal variation that will guide participants through the interaction.
Total
n=751 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
Age, Categorical
Between 18 and 65 years
75 Participants
n=99 Participants
176 Participants
n=107 Participants
158 Participants
n=206 Participants
168 Participants
n=7 Participants
577 Participants
n=31 Participants
Age, Categorical
>=65 years
32 Participants
n=99 Participants
38 Participants
n=107 Participants
54 Participants
n=206 Participants
50 Participants
n=7 Participants
174 Participants
n=31 Participants
Sex: Female, Male
Female
54 Participants
n=99 Participants
104 Participants
n=107 Participants
108 Participants
n=206 Participants
110 Participants
n=7 Participants
376 Participants
n=31 Participants
Sex: Female, Male
Male
53 Participants
n=99 Participants
110 Participants
n=107 Participants
104 Participants
n=206 Participants
108 Participants
n=7 Participants
375 Participants
n=31 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
Race (NIH/OMB)
Black or African American
107 Participants
n=99 Participants
214 Participants
n=107 Participants
212 Participants
n=206 Participants
218 Participants
n=7 Participants
751 Participants
n=31 Participants
Race (NIH/OMB)
White
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
Region of Enrollment
United States
107 participants
n=99 Participants
214 participants
n=107 Participants
212 participants
n=206 Participants
218 participants
n=7 Participants
751 participants
n=31 Participants

PRIMARY outcome

Timeframe: Immediately after the intervention, up to 1 hour

Measure: Intention to talk to a doctor about colorectal cancer screening. Construct: Behavioral intention to communicate Item: The virtual appointment made me want to discuss colon cancer screening options with my doctor. Participants will respond using three 5-point Likert scales that will be summed. The total score ranges from 3 to 15, with higher scores indicating a greater intention to discuss colorectal cancer screening with a healthcare professional. Mean scores closer to 3 reflect lower intention, while mean scores closer to 15 reflect higher intention.

Outcome measures

Outcome measures
Measure
Text-only
n=107 Participants
A virtual health assistant that will consist of photos of the computer-generated doctor with text that will guide participants through the interaction. No voice will accompany the photos or text. Text-only: virtual health assistant that will consist of photos of the computer-generated doctor with text that will guide participants through the interaction. No voice will accompany the photos or text.
High Dialectal
n=214 Participants
A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used high dialectal variation that will guide participants through the interaction. High Dialectal: A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used high dialectal variation that will guide participants through the interaction.
Low Dialectal
n=212 Participants
A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used low dialectal variation that will guide participants through the interaction. Low Dialectal: A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used low dialectal variation that will guide participants through the interaction.
Non-Dialectal
n=218 Participants
A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used no dialectal variation that will guide participants through the interaction. Non-Dialectal: A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used no dialectal variation that will guide participants through the interaction.
Intention to Talk to Doctor About Colorectal Cancer Screening
11.42 units on a scale
Standard Deviation 3.43
11.31 units on a scale
Standard Deviation 3.55
11.87 units on a scale
Standard Deviation 3.27
11.42 units on a scale
Standard Deviation 3.38

Adverse Events

Text-only

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

High Dialectal

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Low Dialectal

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Non-Dialectal

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

Dr. Janice Krieger

Mayo Clinic of Jacksonville

Phone: 904-953-6160

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place