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

Primary Purpose

Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dialectal Features Varied
Video Intervention
VHA with no voice
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • QualtricsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interaction with a VHA with voice

Interaction with a VHA without voice

Arm Description

A virtual health assistant computer-generated doctor who will have a conversation with you.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 8, 2021
Last Updated
July 21, 2022
Sponsor
University of Florida
Collaborators
National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT04705363
Brief Title
A Sociolinguistic-enabled Web Application to Develop Precision Health Intervention for African Americans
Official Title
A Sociolinguistic-enabled Web Application to Develop Precision Health Intervention for African Americans
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3:2 randomization with a control group
Masking
ParticipantInvestigator
Masking Description
Participants will be blind to condition. Investigators will be blind to which participants will be assigned to which interventions.
Allocation
Randomized
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interaction with a VHA with voice
Arm Type
Experimental
Arm Description
A virtual health assistant computer-generated doctor who will have a conversation with you.
Arm Title
Interaction with a VHA without voice
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dialectal Features Varied
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Video Intervention
Intervention Description
Participants will randomized to either receive a video introduction from the voice actor or receive no introduction
Intervention Type
Behavioral
Intervention Name(s)
VHA with no voice
Intervention Description
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 Measure Information:
Title
Credibility score
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janice Krieger, PhD
Phone
352-273-0240
Email
JANICEKRIEGER@UFL.EDU
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Tang
Phone
352-392-0639
Email
tang.kevin@ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice Krieger, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin Tang, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qualtrics
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucas Good

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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