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

NCT04705363 | Completed Results DMC

• 2 other identifiers: IRB202001790-NUL1TR001427
• Study Type: interventional
• Target: 751
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will explore the preliminary efficacy of a colorectal cancer (CRC) screening intervention delivered by Virtual Human Agents (VHAs). Seven hundred fifty participants aged 45 to 75 will be recruited through Qualtrics panels. The study examines how different levels of dialectal linguistic features willingness to be screened for colorectal cancer. Participants will be randomly assigned to interact with one of four VHA conditions: a VHA using non-dialectal linguistic features, a VHA with a low level of dialectal linguistic features integrated, a VHA with a high level of dialectal linguistic features integrated, or a text-only control condition. Following the interaction, participants will complete survey measures to assess perceived willingness to be screened.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Intention to Talk to Doctor About Colorectal Cancer Screening

  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.

  Immediately after the intervention, up to 1 hour

Study Arms (4)

Text-only

ACTIVE COMPARATOR

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.

Behavioral: Text-only

High Dialectal

EXPERIMENTAL

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.

Behavioral: High Dialectal

Low Dialectal

EXPERIMENTAL

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.

Behavioral: Low Dialectal

Non-Dialectal

EXPERIMENTAL

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.

Behavioral: Non-Dialectal

Interventions

High Dialectal BEHAVIORAL

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

Low Dialectal BEHAVIORAL

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

Non-Dialectal BEHAVIORAL

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

Text-only BEHAVIORAL

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

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Out of guidelines for colorectal cancer screening
• No fecal immunochemical test within the last 12 months
• No colonoscopy within the last ten years)

Sponsors & Collaborators

• University of Florida: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Qualtrics

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Dr. Janice Krieger
• Organization: Mayo Clinic of Jacksonville

krieger.janice@mayo.edu

904-953-6160

Study Officials

• Janice Krieger, PhD

  Mayo Clinic of Jacksonville

  PRINCIPAL INVESTIGATOR

• Kevin Tang, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will be blind to condition. Investigators will be blind to which participants will be assigned to which interventions.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A 4-arm randomized experimental message design.

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 12, 2021
• Study Start: June 29, 2021
• Primary Completion: December 18, 2023
• Study Completion: December 18, 2023
• Last Updated: April 18, 2025
• Results First Posted: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)