Depression Clinical Trial
Official title:
COVID-19-Related Health and Practices Among Dental Hygienists
| NCT number | NCT04542915 |
| Other study ID # | ADA20-11 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 29, 2020 |
| Est. completion date | August 31, 2021 |
| Verified date | September 2021 |
| Source | American Dental Association |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
As dental practices reopen their practices during a global pandemic, the risk of 2019 novel coronavirus (COVID-19) infection that dental hygienists face in providing dental care remains unknown. Estimating the occupational risk of COVID-19, and producing evidence on the types of infection control practices and dental practices that may affect COVID-19 risk, is therefore imperative. These findings could be used to describe the prevalence and incidence of COVID-19 among dental hygienists, determine what infection control steps dental hygienists take over time, describe dental hygienists' employment during the COVID-19 pandemic, and estimate whether infection control adherence in dental practice is related to COVID-19 incidence.
| Status | Completed |
| Enrollment | 6976 |
| Est. completion date | August 31, 2021 |
| Est. primary completion date | August 31, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Dental hygienist - Licensed in the United States - 18 years of age or older Exclusion Criteria: - Not employed as a dental hygienist as of March 1, 2020 |
| Country | Name | City | State |
|---|---|---|---|
| United States | American Dental Association | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| American Dental Association | American Dental Hygienists Association |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | COVID-19 probable or confirmed case | 2019 novel coronavirus (COVID-19) case as confirmed by clinician and/or detection of SARS-CoV-2 antigen or antibody | 18 months | |
| Secondary | Anxiety | Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater anxiety. | 12 months | |
| Secondary | Depression | Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater depressive symptoms. | 12 months | |
| Secondary | Dental practice infection control efforts | Self-reports of infection control efforts in the respondents' primary dental practices. | 12 months | |
| Secondary | Personal protective equipment | Availability, frequency of use, and frequency of reuse of personal protective equipment | 12 months | |
| Secondary | Employment status | Self-descriptions of current level of employment as a dental hygienist and reasons for non-employment. | 12 months |
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|---|---|---|---|
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