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临床试验/NCT05607043
NCT05607043已完成不适用

Rutgers Pilot for Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT)- Patient LAB Test

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2021年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
Willingness/Ability to Follow Through With the Study With Surveys, Triage and Testing

研究概览

简要总结

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)

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult 18 years or older; reporting to the Rutgers School of Dental Medicine for a dental visit

排除标准

  • Previous participation

结局指标

主要结局

Willingness/Ability to Follow Through With the Study With Surveys, Triage and Testing

时间窗: 26 days

Percentage of patients who complete the study

Patient Willingness to Participate in the Study

时间窗: Day 1

Percentage of 36 patients who were approached to enroll in the study who actually enrolled

Patient Test Completion

时间窗: Day 1

Percentage of patients with completed SARS-CoV-2 testing

Percentage of Subjects Who Complete Study Activities to Optimize Gap Between Testing and Study Visit

时间窗: From initial consent through study completion- approximately 4 weeks

Percentage of subjects completing study activities within the defined optimal window

Ease of Complying With Protocol

时间窗: Day 26

Number of participants indicating that it was easy to complete the surveys

Percent of Patients Who Completed All of the Required Surveys

时间窗: 1 week

Percentage of patients participating in the study who completed pre-visit, triage and post-visit surveys

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cecile A. Feldman, DMD

Professor

Rutgers, The State University of New Jersey

研究点 (2)

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