NCT04389476

Brief 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 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)".

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

3.1 years

First QC Date

May 14, 2020

Last Update Submit

June 12, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    3 years

Study Arms (4)

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)

Interventions

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.

Community residentsMedical staff in high contact with patientsOther personnel in low contact with patientsPatients

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1\. Medical staff in high contact with patients 2. Other personnel in low contact with patients 3. Patients 4. Community residents.

You may qualify if:

  • \>20 years old. 2. Medical staff and patients from different tiers hospitals in Taiwan. 3.Community residents in Taiwan

You may not qualify if:

  • \< 20 years old. 2. These cases who had disabilities can't complete our assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President, Kaohsiung Municipal Kai-Suan Psychiatric Hospital

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 15, 2020

Study Start

June 15, 2020

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

June 16, 2020

Record last verified: 2020-06