The Psychological Impact of COVID-19NCT04389476
The Impact and Coping Strategy of COVID-19 Among Taiwan Society and Medical and Nursing Institutes
An observational study of The Psychological Impact of COVID-19, run by Kaohsiung Kai-Suan Psychiatric Hospital.
Trial summary
The Coronavirus disease 2019 (COVID-19) had its outbreak in late 2019 in China and is considered a biological disaster. With medical organizations and staff on the frontline, the investigators should conduct assessments, for the different tiers of medical staff, patients, and community residents, on the short- term… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- The Psychological Impact of COVID-19
- What is being tested?
- Standardized crisis management and coping protocol plan toward Coronavirus disease 2019 (COVID-19)
- How many people
- 2,500 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2020to 31 Jul 2023
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Medical staff in high contact with patients 2. Other personnel in low contact with patients 3. Patients 4. Community residents.
Who may be able to join
- 1.>20 years old. 2. Medical staff and patients from different tiers hospitals in Taiwan. 3.Community residents in Taiwan
Who cannot join
- 1.< 20 years old. 2. These cases who had disabilities can't complete our assessments.
About this study
Official title: The Impact and Coping Strategy of Taiwan Society and Medical and Nursing Institutes Toward the Biological Disaster-- Corona Virus Disease 2019 (COVID-19) as An Example
The Coronavirus disease 2019 (COVID-19) had its outbreak in late 2019 in China and is considered a biological disaster. With medical organizations and staff on the frontline, the investigators should conduct assessments, for the different tiers of medical staff, patients, and community residents, on the short- term psychological and mental disabilities or danger factors that they might have faced. As such, the investigators can design and establish a set of evaluative indicators of the risks of biological disasters, and strategies to manage guide and cope, and internal/ external testing strategies. These work in guaranteeing quality and performance, and as such, establishing "Digital Platform for Integrated Research of Coronavirus disease 2019 (COVID-19)".
- Conditions
- The Psychological Impact of COVID-19
- Being tested
- Standardized crisis management and coping protocol plan toward Coronavirus disease 2019 (COVID-19)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized crisis management and coping protocol plan toward Coronavirus disease 2019 (COVID-19)Other
Establish standardized crisis management and coping protocol plan toward Coronavirus disease 2019 (COVID-19) for the different tiers of medical staff, patients, and community residents.
Then explore the psychological impact and mental disabilities under the intervention and controlling related factors.
| Study group | Role | What they receive |
|---|---|---|
| Medical staff in high contact with patients | Not described Receives: Other: Standardized crisis management and coping protocol plan toward Coronavirus disease 2019 (COVID-19) | |
| Other personnel in low contact with patients | Not described Receives: Other: Standardized crisis management and coping protocol plan toward Coronavirus disease 2019 (COVID-19) | |
| Patients | Not described Receives: Other: Standardized crisis management and coping protocol plan toward Coronavirus disease 2019 (COVID-19) | |
| Community residents | Not described Receives: Other: Standardized crisis management and coping protocol plan toward Coronavirus disease 2019 (COVID-19) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological impacts by CoronaVirus Disease 2019(COVID-19)
Acute and chronic psychological impacts on medical and nursing staff and the mass public by CoronaVirus Disease 2019(COVID-19)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start15 Jun 2020 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Psychological Impact of COVID-19Studies of the same condition, open and under way.
- 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
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Kai-Suan Psychiatric Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Frank Huang-Chih Chou, MD, MS, PhD, Kaohsiung Kai-Suan Psychiatric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389476
- Sponsor's protocol ID
- KSPH-2020-03
- Status last verified
- Jun 2020
- First submitted
- 14 May 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact and Coping Strategy of Taiwan Society and Medical and Nursing Institutes Toward the Biological Disaster-- Corona Virus Disease 2019 (COVID-19) as An Example
- ClinicalTrials.gov ID
- NCT04389476
- Acronym / sponsor ID
- KSPH-2020-03
- Conditions
- The Psychological Impact of COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Kaohsiung Kai-Suan Psychiatric HospitalOther government
- Study start
- 15 Jun 2020 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 15 May 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.
The Coronavirus disease 2019 (COVID-19) had its outbreak in late 2019 in China and is considered a biological disaster. With medical organizations and staff on the frontline, the investigators should conduct assessments, for the different tiers of medical staff, patients, and community residents, on the short- term psychological and mental disabilities or danger factors that they might have faced. As such, the investigators can design and establish a set of evaluative indicators of the risks of biological disasters, and strategies to manage guide and cope, and internal/ external testing strategies. These work in guaranteeing quality and performance, and as such, establishing "Digital Platform for Integrated Research of Coronavirus disease 2019 (COVID-19)".
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Medical staff in high contact with patients | – | Other: Standardized crisis management and coping protocol plan toward Coronavirus disease 2019 (COVID-19) |
| Other personnel in low contact with patients | – | Other: Standardized crisis management and coping protocol plan toward Coronavirus disease 2019 (COVID-19) |
| Patients | – | Other: Standardized crisis management and coping protocol plan toward Coronavirus disease 2019 (COVID-19) |
| Community residents | – | Other: Standardized crisis management and coping protocol plan toward Coronavirus disease 2019 (COVID-19) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Medical staff in high contact with patients 2. Other personnel in low contact with patients 3. Patients 4. Community residents.
Key inclusion criteria (1 listed)
- 1.>20 years old. 2. Medical staff and patients from different tiers hospitals in Taiwan. 3.Community residents in Taiwan
Key exclusion criteria (1 listed)
- 1.< 20 years old. 2. These cases who had disabilities can't complete our assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized crisis management and coping protocol plan toward Coronavirus disease 2019 (COVID-19)Establish standardized crisis management and coping protocol plan toward Coronavirus disease 2019 (COVID-19) for the different tiers of medical staff, patients, and community residents. Then explore the psychological impact and mental disabilities under the intervention and controlling related factors. | Other | Community residents, Medical staff in high contact with patients, Other personnel in low contact with patients, Patients |
Primary outcome
Psychological impacts by CoronaVirus Disease 2019(COVID-19)
Time frame: 3 years
Acute and chronic psychological impacts on medical and nursing staff and the mass public by CoronaVirus Disease 2019(COVID-19)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of The Psychological Impact of COVID-19, run by Kaohsiung Kai-Suan Psychiatric Hospital.
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 1 inclusion and 1 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 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological impacts by CoronaVirus Disease 2019(COVID-19) (time frame: 3 years). 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 16 Jun 2020.