Virus; PneumoniaNCT04260308
A Survey of Psychological Status of Medical Workers and Residents in the Context of 2019 Novel Coronavirus Pneumonia
An observational study of Virus; Pneumonia, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Due to the outbreak of 2019 Novel Coronavirus Pneumonia in Wuhan, Hubei province, medical staff and residents are facing great psychological pressure, the investigator plan to use electronic questionnaire to carry out investigation research. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Virus; Pneumonia
- How many people
- 30,000 participants
- Where
- 1 siteChina
- Study dates
- 3 Feb 2020to 20 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: medical staff and residents of China who is volunteer to take part in the investigation
Who may be able to join
- can use mobil phone or computer
- volunteer to take part in the investigation
Who cannot join
- can not use phone or computer
- unwilling to take part in the investigation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital，Tongji Medical College Affiliated，Huazhong University of Science ＆ Technology
Wuhan, Hubei, 430030
Yuhong Dai, +86 13476229575, eier_dai@163.com
About this study
Official title: A Survey of Psychological Status of Medical Workers and Residents in the Context of 2019 Novel Coronavirus Pneumonia in Wuhan, China
Due to the outbreak of 2019 Novel Coronavirus Pneumonia in Wuhan, Hubei province, medical staff and residents are facing great psychological pressure, the investigator plan to use electronic questionnaire to carry out investigation research.
Read the detailed description
From December 2019, 12 cases of new coronavirus pneumonia broke out in Wuhan, and then the epidemic spread rapidly. Till February 1, 2020, there were 14446 confirmed cases in China, 19544 suspected cases, and 304 deaths. There were confirmed cases reported in 34 provincial administrative regions in China; 23 foreign countries reported new coronavirus pneumonia cases, 147 confirmed cases. In the face of the rapid spread of the epidemic, people's panic and anxiety have seriously affected the prevention and control of the epidemic. In the face of the occupational exposure risk and treatment brought by the sudden outbreak of the epidemic, the change of mental state of medical staff may affect the prevention and control of the epidemic. In order to help the epidemic prevention and control, the investigator plan to carry out investigation research.
- Conditions
- Virus; Pneumonia
- Medical subject headings
- Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| residents | 1. Voluntary residents 2. Can use mobile phone or computer | |
| medical staff | 1. Voluntary residents 2. Can use mobile phone or computer |
What is being measured
The primary outcome is the main question the study is designed to answer.
GHQ-12(general health questionnaire-12)
GHQ-12(general health questionnaire-12): minimal score 0, maximal score 12, higher scores mean a better or worse outcome.
Measured: 2 weeks
Secondary outcomes (1)
IES-R(Impact of Event Scale-Revised)
IES-R(Impact of Event Scale-Revised):score range:0-88, the higher the worse
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start3 Feb 2020
- Primary completion15 Apr 2020 (estimated)
- Study completion20 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virus; PneumoniaStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianglin Yuan, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260308
- Sponsor's protocol ID
- IRBID:TJ-C 20200107
- Status last verified
- Feb 2020
- First submitted
- 3 Feb 2020
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey of Psychological Status of Medical Workers and Residents in the Context of 2019 Novel Coronavirus Pneumonia in Wuhan, China
- ClinicalTrials.gov ID
- NCT04260308
- Acronym / sponsor ID
- IRBID:TJ-C 20200107
- Conditions
- Virus; Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 15 Apr 2020 (estimated)
- Study completion
- 20 Apr 2020 (estimated)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Due to the outbreak of 2019 Novel Coronavirus Pneumonia in Wuhan, Hubei province, medical staff and residents are facing great psychological pressure, the investigator plan to use electronic questionnaire to carry out investigation research.
Detailed description
From December 2019, 12 cases of new coronavirus pneumonia broke out in Wuhan, and then the epidemic spread rapidly. Till February 1, 2020, there were 14446 confirmed cases in China, 19544 suspected cases, and 304 deaths. There were confirmed cases reported in 34 provincial administrative regions in China; 23 foreign countries reported new coronavirus pneumonia cases, 147 confirmed cases. In the face of the rapid spread of the epidemic, people's panic and anxiety have seriously affected the prevention and control of the epidemic. In the face of the occupational exposure risk and treatment brought by the sudden outbreak of the epidemic, the change of mental state of medical staff may affect the prevention and control of the epidemic. In order to help the epidemic prevention and control, the investigator plan to carry out investigation research.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| residents | – | –1. Voluntary residents 2. Can use mobile phone or computer |
| medical staff | – | –1. Voluntary residents 2. Can use mobile phone or computer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- medical staff and residents of China who is volunteer to take part in the investigation
Key inclusion criteria (2 listed)
- can use mobil phone or computer
- volunteer to take part in the investigation
Key exclusion criteria (2 listed)
- can not use phone or computer
- unwilling to take part in the investigation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
GHQ-12(general health questionnaire-12)
Time frame: 2 weeks
GHQ-12(general health questionnaire-12): minimal score 0, maximal score 12, higher scores mean a better or worse outcome.
1 secondary outcome
IES-R(Impact of Event Scale-Revised)
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Virus; Pneumonia, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuhong Dai (+86 13476229575, eier_dai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GHQ-12(general health questionnaire-12) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.