- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05812599
Understanding COVID-19 Testing Knowledge and Practices Among 2-1-1 Helpline Callers
April 10, 2023 updated by: Matthew Kreuter, Washington University School of Medicine
Rapid Acceleration of Diagnostics Underserved Populations Supplement: Understanding COVID-19 Testing Knowledge and Practices Among 2-1-1 Helpline Callers
The purpose of this study is to identify promising health education strategies and culturally appropriate messages for use by 2-1-1 practitioners to promote coronavirus disease of 2019 (COVID) testing behaviors.
Previous study findings and evidence-based health communication and education tactics were integrated to create an interactive learning module that includes four narrative scenarios, illustrations, and accompanying questions and responses that inform the audience about COVID testing guidelines.
The study will test the effectiveness of the interactive learning module with 2-1-1 callers (n=300) in Connecticut, North Carolina, and Nebraska.
Participants' contact information will be shared with us by 2-1-1 with the participants' given consent.
The study team will send the potential participant via text message a link to a survey that includes a screen where they will provide informed consent.
Those who provide consent will be randomly assigned to receive one of two surveys.
The inclusion of the interactive learning module is what varies across the surveys.
An experimental group will receive the learning module with a study team-developed pre- and post-survey, and the control group will receive only the study team-developed pre- and post-survey.
The post-survey contains questions regarding information covered in the interactive learning module.
It is hypothesized that those who complete the interactive learning module in the experimental group will score better on the post-survey questions when compared to the control group.
All participants, regardless of experimental or control condition, will receive an information sheet with the most up-to-date scientific guidelines for COVID testing.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
298
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63130
- Washington University in St. Louis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Individuals who called 211 in Connecticut, Nebraska, or North Carolina on behalf of themselves or their families
- Must be 18 or older
- Must have English language proficiency
- Must be willing to be contacted via text messages or email
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: COVID Test Learning Module
In the experimental condition, participants will respond to survey questions (pre-exposure) before being presented with four narrative scenarios, questions, and accompanying messages about COVID testing (exposure), followed by post-test survey questions about COVID testing behaviors (post-exposure).
|
The COVID Test Learning Module will present four multi-part character scenarios that someone might experience when considering testing for COVID-19.
Participants will answer questions about the character's behavior.
Accurate guidelines will be provided in response to each scenario to educate participants about what to do in nuanced COVID testing decision-making situations.
|
|
No Intervention: Control
In the control condition, participants will respond to survey questions (pre-exposure) and post-test survey questions about COVID testing behaviors (post-exposure) only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of participants who answer post-test questions correctly
Time Frame: Through survey completion, an average of 10-15 minutes.
|
The primary objective of this study is to evaluate differences in knowledge regarding COVID testing between 2-1-1 callers randomized to the control vs. experimental group.
Participants who do better would answer more items correctly on the COVID prevention knowledge post-test.
Assessed using a non-parametric t-test.
|
Through survey completion, an average of 10-15 minutes.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with knowledge gained after exposure to learning module
Time Frame: Through survey completion, an average of 10-15 minutes.
|
A secondary outcome is to identify if exposure to the learning module increased participant knowledge about COVID prevention.
Assessed by comparing the percentage of correct answers from questions within the learning module to the percentage of correct answers in the post-test.
|
Through survey completion, an average of 10-15 minutes.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 22, 2022
Primary Completion (Actual)
January 20, 2023
Study Completion (Actual)
January 20, 2023
Study Registration Dates
First Submitted
November 29, 2022
First Submitted That Met QC Criteria
April 10, 2023
First Posted (Actual)
April 13, 2023
Study Record Updates
Last Update Posted (Actual)
April 13, 2023
Last Update Submitted That Met QC Criteria
April 10, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 3R01CA235773-03S1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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