NCT04365348

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

April 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
29 days until next milestone

Study Start

First participant enrolled

May 27, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

3 years

First QC Date

April 25, 2020

Last Update Submit

November 27, 2021

Conditions

Keywords

StressAnxietyDepressionFamilies

Outcome Measures

Primary Outcomes (1)

  • Stress level

    measured by the 10-item Perceived Stress Scale

    1 month

Secondary Outcomes (8)

  • Stress level

    3 months

  • Negative emotion

    3 months

  • Psychological response to trauma

    1 month and 3 months

  • Severity of insomnia symptoms and the associated daytime impairment

    1 month and 3 months

  • Resilience

    1 month and 3 months

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Refusal to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agnes

Hong Kong, 852, Hong Kong

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32031570BACKGROUND
  • Chua SE, Cheung V, McAlonan GM, Cheung C, Wong JW, Cheung EP, Chan MT, Wong TK, Choy KM, Chu CM, Lee PW, Tsang KW. Stress and psychological impact on SARS patients during the outbreak. Can J Psychiatry. 2004 Jun;49(6):385-90. doi: 10.1177/070674370404900607.

    PMID: 15283533BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Agnes YK Lai, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnes YK Lai, PhD

CONTACT

Mary SM Ip, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 25, 2020

First Posted

April 28, 2020

Study Start

May 27, 2020

Primary Completion

May 31, 2023

Study Completion

June 30, 2023

Last Updated

November 30, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

It has not been mentioned in the participants' consent

Locations