The Psychological Impact of COVID-19 Outbreak on COVID-19... | NCT04365348

Studies
The Psychological Impact of COVID-19 Outbreak on COVID-19 Survivors and Their Families

NCT04365348

Sponsor

The University of Hong Kong

Status

Unknown status

Last Update Posted

Nov 30, 2021Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Mental Health Wellness 1

Interventions

Not provided

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 27, 2020Actual

Primary Completion Date

May 31, 2023Estimated

Completion Date

Jun 30, 2023Estimated

First Submitted Date

Apr 25, 2020

First Submission Date that Met QC Criteria

Apr 25, 2020

First Posted Date

Apr 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2021

Last Update Posted Date

Nov 30, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Agnes Yuen-Kwan Lai, Assistant Professor, The University of Hong KongPrincipal Investigator

Lead Sponsor

The University of Hong KongOTHER

Collaborators

Name	Class
Queen Mary Hospital, Hong Kong	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients with COVID-19 diagnoses are treated under isolation in hospitals and with high-stress level. Currently, there is little information on the mental health implications of exposure amongst COVID-19 survivors and their family members. Research exploring the psychological impact amongst survivors of exposure to COVID-19 is desperately needed to understand the effects, mental health toll, and support required in survivors of COVID-19. This study aims to assess the psychological impact of the COVID-19 outbreak on COVID-19 survivors and their family members.

Detailed Description

Since the 2019 coronavirus disease (COVID-19) was first reported, it has been rapidly transmitted and has aroused enormous global attention. Infected patients may develop severe and even fatal respiratory symptoms such as acute respiratory distress syndrome (ARDS) and acute respiratory failure, ending up in intensive care. Patients with COVID-19 diagnoses are treated under isolation in hospitals and with high-stress level. The stress and psychological impact on patients were also correlated significantly with several adverse psychological effects, such as fatigue, fear of social contact, poor sleep, loneliness, and depressed mood. The psychological impact of COVID-19 may also evolve and last for a prolonged period after discharge from the hospital. However, there is currently little information on the mental health implications of exposure amongst COVID-19 survivors and their family members. Research exploring the psychological impact amongst survivors of exposure to COVID-19 is desperately needed to understand the effects, mental health toll, and support required in survivors of COVID-19. This study aims to assess the psychological impact of the COVID-19 outbreak on COVID-19 survivors and their family members.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stress level	measured by the 10-item Perceived Stress Scale	1 month

Secondary Outcomes

Measure	Description	Time Frame
Stress level	measured by the 10-item Perceived Stress Scale	3 months
Negative emotion	measured by the 13-item Hospital Anxiety and Depression Scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COVID-19 survivors (i.e., diagnosed with COVID-19 and discharged from the hospital) and/or a family member of a COVID-19 survivor;
Aged 18 years or above;
No medical diagnosis of psychiatric illness

Exclusion Criteria:

• Refusal to give consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

COVID-19 Survivors: 300; Family members of COVID-19 Survivors:300

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Agnes YK Lai, PhD	Contact	39176328		agneslai@hku.hk
Mary SM Ip, MD	Contact	22554455		msmip@hku.hk

Overall Officials

Name	Affiliation	Role
Agnes YK Lai, PhD	The University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Agnes	Recruiting	Hong Kong		852	Hong Kong

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32031570	Background	Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
15283533	Background

ID	Term
D001008	Anxiety Disorders
D003863	Depression

ID	Term
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior