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Rutgers Pilot for PREDICT- Patient LAB Test

Primary Purpose

SARS-CoV2 Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Testing for SARS CoV2 RNA
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for SARS-CoV2 Infection focused on measuring Screening, Lab-based testing, Asymptomatic patients, Perception of safety, Feasibility

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Adult 18 years or older; reporting to the Rutgers School of Dental Medicine for a dental visit Exclusion Criteria: Previous participation

Sites / Locations

  • Rutgers School of Dental Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

SARS-CoV-2 testing

Arm Description

There is only one arm in this study- the study is a non-randomized pilot. All the subjects will be tested for SARS CoV 2 viral infection as described.

Outcomes

Primary Outcome Measures

Patient Willingness to Participate in the Study
Percentage of 36 patients who were approached to enroll in the study who actually enrolled
Willingness/Ability to Follow Through With the Study With Surveys, Triage and Testing
Percentage of patients who complete the study
Patient Test Completion
Percentage of patients with completed SARS-CoV-2 testing
Percentage of Subjects Who Complete Study Activities to Optimize Gap Between Testing and Study Visit
Percentage of subjects completing study activities within the defined optimal window
Ease of Complying With Protocol
Number of participants indicating that it was easy to complete the surveys
Percent of Patients Who Completed All of the Required Surveys
Percentage of patients participating in the study who completed pre-visit, triage and post-visit surveys

Secondary Outcome Measures

Full Information

First Posted
October 31, 2022
Last Updated
September 13, 2023
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT05607043
Brief Title
Rutgers Pilot for PREDICT- Patient LAB Test
Official Title
Rutgers Pilot for Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT)- Patient LAB Test
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 31, 2021 (Actual)
Primary Completion Date
February 25, 2021 (Actual)
Study Completion Date
February 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
A pilot study was initiated to assess feasibility of testing asymptomatic dental patients presenting to the Oral Medicine Clinic at Rutgers School of Dental Medicine for SARS-CoV-2 viral RNA using an FDA approved RT-PCR test for SARS-CoV2- an RNA RT-PCR assay (Accurate Diagnostics)
Detailed Description
Patients with upcoming dental appointments at the Oral Medicine clinic at Rutgers School of Dental Medicine were contacted to solicit interest in participating in a pilot study to assess feasibility of testing asymptomatic dental patients for SARS CoV 2 infection using an RNA RT-PCR assay. Interested subjects completed a previsit survey after confirming their interest electronically. Subsequently, they received kit to collect their saliva sample at home along with instructions on how to do so. They were directed to drop off their saliva samples for testing at the dental clinic and signed the consent form at that time. After confirming a negative result, the patients were subsequently triaged over the phone for any symptoms and the following day, presented for their dental visit. On the day of their visit, they were triaged, completed their dental visit and were surveyed to get their feedback on the study procedures and their perceptions of safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV2 Infection
Keywords
Screening, Lab-based testing, Asymptomatic patients, Perception of safety, Feasibility

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot study to assess feasibility of testing asymptomatic dental patients for SARS-CoV-2 antigen using lab-based RNA RT-PCR testing
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SARS-CoV-2 testing
Arm Type
Other
Arm Description
There is only one arm in this study- the study is a non-randomized pilot. All the subjects will be tested for SARS CoV 2 viral infection as described.
Intervention Type
Device
Intervention Name(s)
Testing for SARS CoV2 RNA
Intervention Description
Device: Testing for SARS CoV2 RNA- lab-based RNA RT-PCR testing
Primary Outcome Measure Information:
Title
Patient Willingness to Participate in the Study
Description
Percentage of 36 patients who were approached to enroll in the study who actually enrolled
Time Frame
Day 1
Title
Willingness/Ability to Follow Through With the Study With Surveys, Triage and Testing
Description
Percentage of patients who complete the study
Time Frame
26 days
Title
Patient Test Completion
Description
Percentage of patients with completed SARS-CoV-2 testing
Time Frame
Day 1
Title
Percentage of Subjects Who Complete Study Activities to Optimize Gap Between Testing and Study Visit
Description
Percentage of subjects completing study activities within the defined optimal window
Time Frame
From initial consent through study completion- approximately 4 weeks
Title
Ease of Complying With Protocol
Description
Number of participants indicating that it was easy to complete the surveys
Time Frame
Day 26
Title
Percent of Patients Who Completed All of the Required Surveys
Description
Percentage of patients participating in the study who completed pre-visit, triage and post-visit surveys
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult 18 years or older; reporting to the Rutgers School of Dental Medicine for a dental visit Exclusion Criteria: Previous participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecile A Feldman
Organizational Affiliation
Rutgers School of Dental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers School of Dental Medicine
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
If the COVID test results show that a participant is positive for COVID-19, the study staff will tell the participant the results. The study staff will be required to give the participant's name to the state's Department of Public Health if the participant tests positive because this is the law. At the end of the study, de-identified data will be provided to the National Coordinating Center.
Citations:
Citation
American Dental Association COVID-19 Toolkit - Update to Office Procedures During COVID-19. https://www.ada.org/-/media/project/ada-organization/ada/ada-org/files/resources/coronavirus/update_to_office_procedures_during_covid19.pdf accessed on November 11, 2021.
Results Reference
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PubMed Identifier
33071007
Citation
Estrich CG, Mikkelsen M, Morrissey R, Geisinger ML, Ioannidou E, Vujicic M, Araujo MWB. Estimating COVID-19 prevalence and infection control practices among US dentists. J Am Dent Assoc. 2020 Nov;151(11):815-824. doi: 10.1016/j.adaj.2020.09.005.
Results Reference
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PubMed Identifier
34176567
Citation
Shirazi S, Stanford CM, Cooper LF. Testing for COVID-19 in dental offices: Mechanism of action, application, and interpretation of laboratory and point-of-care screening tests. J Am Dent Assoc. 2021 Jul;152(7):514-525.e8. doi: 10.1016/j.adaj.2021.04.019. Epub 2021 May 4. Erratum In: J Am Dent Assoc. 2021 Sep;152(9):719.
Results Reference
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Rutgers Pilot for PREDICT- Patient LAB Test

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