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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04705363
• Other study ID #: IRB202001790-N
• Secondary ID: UL1TR001427
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2022
• Source: University of Florida
• Contact: Janice Krieger, PhD
• Phone: 352-273-0240
• Email: JANICEKRIEGER[@]UFL.EDU
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study will explore the preliminary efficacy of a colorectal cancer (CRC) screening intervention delivered by virtual health assistants (VHAs). Participants will include 750 African American patients in the US between the ages of 45 and 75 recruited through Qualtrics panels. The main research question is: How does the integration of different levels of dialect density of the linguistic features of African American English (AAE) influence the perceived credibility of a Black VHA. Four types of VHAs will be presented to our patients: a VHA with Standardized American English (SAE) linguistic features, a VHA with a low level of African American English (AAE) linguistic features integrated, a VHA with a high level of African American English (AAE) linguistic features integrated, and a text-only control condition. Survey questions will be used to obtain credibility judgments about VHAs post-interaction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Out of guidelines for colorectal cancer screening

• No fecal immunochemical test within the last 12 months

• No colonoscopy within the last ten years)

Exclusion Criteria:

• Must meet inclusion criteria

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Dialectal Features Varied
Participants will randomized to interact with a VHA that speaks either Standardized American English, a low level of African American English, or a high level of African American English
• Video Intervention
Participants will randomized to either receive a video introduction from the voice actor or receive no introduction
• VHA with no voice
virtual health assistant that will consist of photos of the computer-generated doctor with text that will guide you through the interaction. No voice will accompany the photos or text.

Locations

Country	Name	City	State
United States	Qualtrics	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Center for Advancing Translational Science (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Credibility score	The primary outcome in the current pilot study is credibility score. We expect that source credibility is the mechanism through which intentions to screen will be strengthened. Credibility score will be determined on a Source Credibility Scale (McCroskey & Teven, 1999) from 1 to 7, 1 being "Credible" and 7 being "Not Credible". Lower scores indicate VHA credibility. Higher scores indicate a lack of VHA credibility.	6 months