COVID-19 Infection Clinical Trial
— PREDICTOfficial title:
Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT): A PBRN Feasibility Study on COVID-19 Screening in Dental
Verified date | September 2023 |
Source | Rutgers, The State University of New Jersey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The study team will conduct a feasibility study to develop and test out procedures for improved triage and COVID-19 testing in dental practices to increase safety and perceptions of the safety of Dental Health Care Workers (DHCW) and their patients. DHCWs in offices with Practice-Based Regional Network (PBRN) members and their patients will be recruited to participate in one of two protocols. The first, point-of-care (POC), will test out procedures for point-of-care SARS-CoV-2 antigen testing in the dental office along with enhanced triage using pulse oximeters. The second, laboratory (LAB), will test out procedures for a saliva-based laboratory SARS-CoV-2 viral test along with enhanced triage. The feasibility of implementing COVID-related testing and enhanced triage procedures in the dental setting will provide preliminary data to inform a larger network-wide study grant application.
Status | Completed |
Enrollment | 72 |
Est. completion date | December 31, 2022 |
Est. primary completion date | October 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: A Dental Health Care Worker must meet all of the following criteria to be eligible to participate in the study: - Be 18 years or older - Be a National Dental PBRN member dentist or work in a dental office with a National Dental PBRN member dentist who consents to study participation - Be able to understand the informed consent. - Provide signed and dated informed consent form - Be able to understand all instructions for data collection instruments - Be willing and able to comply with all study procedures, including COVID-19 testing, and be available for the duration of the study A Patient must meet all of the following criteria to be eligible to participate in the study: - Be 18 years or older - Be able to understand the informed consent. - Have a computer or electronic tablet with internet access - Able to complete consent and questionnaire on a computer or electronic tablet - Provide signed and dated informed consent form - Be able to understand all instructions for data collection instruments - Be willing and able to comply with all study procedures, including having a COVID-19 test performed Exclusion Criteria: - Children less than 18 years will not be able to participate. - Participants would be excluded if they participated in the feasibility study previously conducted at Rutgers University. |
Country | Name | City | State |
---|---|---|---|
United States | Rutgers School of Dental Medicine | Newark | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Rutgers, The State University of New Jersey | Kaiser Foundation Research Institute, National Institute of Dental and Craniofacial Research (NIDCR), The National Dental Practice-Based Research Network, University of Alabama at Birmingham, University of Illinois at Chicago, University of Rochester |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perception of Safety | Participants perception of safety in the dental office. Outcome measure is a score on a scale from 0 to 100 where 0=has unsafe as one can possibly feel and 100=as safe as one can possibly feel. All participants (DHCW and patients) were asked to indicate how safe they would feel seeking dental care if all dental office workers, but not patients, were regularly tested: how safe they would feel seeking care if all patients, but not dental care workers, were tested prior to their dental appointments; and how safe they would feel seeking dental care if all dental workers were regularly tested AND all patients were tested prior to their dental appointments. | For DHCW at Day 28 (+/- 14 days), For Patients at their dental visit (day 1) | |
Secondary | Specimen Preference | Ranking of the type of specimen participants preferred. Outcome measure is a score on a scale from 1 to 6 where 1=the most preferred specimen type and 6 the least preferred specimen type. Scores could not be used twice providing a ranking of specimen preference. | For DHCWs at Day 28 (+/- 13 days); For patients at the time of their dental visit (Day 1) | |
Secondary | Testing Protocol Preference | COVID-19 testing method preferred by subjects. Outcomes measure is a score on a scale where testing protocols are ranking from 1 to 4 with 1 being the most preferred method and 4 is the least preferred method. Score could not be used twice with the scores indicating the subject's testing preference. | For DHCWs at Day 28 (+/- 14 days); For Patients at time of their dental visit (Day 1) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04997551 -
Double Blind Randomized Clinical Trial of Use of Colchicine Added to Standard Treatment in Hospitalized With Covid-19
|
Phase 3 | |
Recruiting |
NCT04977024 -
SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer
|
Phase 2 | |
Completed |
NCT05049226 -
Third Dose Vaccination With AstraZeneca or Pfizer COVID-19 Vaccine Among Adults Received Sinovac COVID-19 Vaccine
|
Phase 2 | |
Active, not recruiting |
NCT04666025 -
SARS-CoV-2 Donor-Recipient Immunity Transfer
|
||
Terminated |
NCT04455815 -
A Trial Looking at the Use of Camostat in People Who Have Tested Positive for Coronavirus (COVID-19) (SPIKE-1)
|
Phase 2 | |
Completed |
NCT04662437 -
The Status of Parathyroid Hormone Secretion in Covid-19 Patients
|
||
Recruiting |
NCT05792878 -
Study of COVID-19 Infection and Its Clinical Prognosis in Chronic Hepatitis B Patients With Antiviral Therapy
|
||
Completed |
NCT04659200 -
Thyroid Function Tests and Status of Thyroid Autoantibodies in Covid-19 Patients
|
||
Recruiting |
NCT04470583 -
Evaluating Clinical Parameters of COVID-19 in Pregnancy
|
||
Withdrawn |
NCT04377568 -
Efficacy of Human Coronavirus-immune Convalescent Plasma for the Treatment of COVID-19 Disease in Hospitalized Children
|
Phase 2 | |
Completed |
NCT04848610 -
The Factors That Affect the Infection of COVID-19
|
||
Recruiting |
NCT04582903 -
Send-In Sample Collection for Comprehensive Analyses of Innate and Adaptive Immune Responses During Acute COVID-19 and Convalescence
|
||
Recruiting |
NCT06032000 -
Evaluation of Safety and Immunogenicity of a SARS-CoV-2(Severe Acute Respiratory Syndrome Coronavirus 2) Booster Vaccine (LEM-mR203)
|
Phase 1 | |
Terminated |
NCT04941703 -
"CHANGE COVID-19 Severity"
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04639466 -
A Synthetic MVA-based SARS-CoV-2 Vaccine, GEO-CM04S1, for the Prevention of COVID-19 Infection
|
Phase 1/Phase 2 | |
Completed |
NCT04575038 -
CRISIS2: A Phase 2 Study of the Safety and Antiviral Activity of Brequinar in Non-hospitalized Pts With COVID-19
|
Phase 2 | |
Recruiting |
NCT05022446 -
The Impact of COVID-19 on Pulmonary Procedures
|
||
Completed |
NCT04347798 -
IMPACT: IMPact of Antimalarials on Covid-19 Infections in RAPPORT
|
||
Active, not recruiting |
NCT04650178 -
Well-being in Cancer Patients With Neuropathy During COVID-19 Who Participated in Prior Clinical Trials
|
||
Recruiting |
NCT04169542 -
Impact of COVID-19 Pandemic on Out-of-Pocket Costs, Lost Wages, and Unemployment in Patients With Breast Cancer Undergoing Breast Surgery
|