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

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ClinicalTrials.gov Identifier: NCT04705363
Recruitment Status : Recruiting
First Posted : January 12, 2021
Last Update Posted : September 16, 2021
Sponsor:
Collaborator:
National Center for Advancing Translational Science (NCATS)
Information provided by (Responsible Party):
University of Florida

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Dialectal Features Varied Behavioral: Video Intervention Behavioral: VHA with no voice Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3:2 randomization with a control group
Masking: Double (Participant, Investigator)
Masking Description: Participants will be blind to condition. Investigators will be blind to which participants will be assigned to which interventions.
Primary Purpose: Screening
Official Title: A Sociolinguistic-enabled Web Application to Develop Precision Health Intervention for African Americans
Actual Study Start Date : June 29, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interaction with a VHA with voice
A virtual health assistant computer-generated doctor who will have a conversation with you.
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

Behavioral: Video Intervention
Participants will randomized to either receive a video introduction from the voice actor or receive no introduction

Active Comparator: Interaction with a VHA without voice
A 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.
Behavioral: 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.




Primary Outcome Measures :
  1. Credibility score [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • African American
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04705363


Contacts
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Contact: Janice Krieger, PhD 352-273-0240 JANICEKRIEGER@UFL.EDU
Contact: Kevin Tang 352-392-0639 tang.kevin@ufl.edu

Locations
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United States, Florida
Qualtrics Recruiting
Gainesville, Florida, United States, 32611
Contact: Lucas Good         
Sponsors and Collaborators
University of Florida
National Center for Advancing Translational Science (NCATS)
Investigators
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Principal Investigator: Janice Krieger, PhD University of Florida
Principal Investigator: Kevin Tang, PhD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04705363    
Other Study ID Numbers: IRB202001790-N
UL1TR001427 ( U.S. NIH Grant/Contract )
First Posted: January 12, 2021    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases