COVID-19 - Quality of Life After Infection

May 4, 2020 updated by: Joseph Walline, Chinese University of Hong Kong
This study aims to investigate the quality of life of COVID-19 patients after recovery and discharge from the hospital. Patients following-up at the PWH outpatient clinics will be enrolled for further evaluation via telephone follow-up at one, three, and six months after hospital discharge. SF12, EQ-5D-5L and work status standardized quantitative assessments of quality of life will be implemented via telephone follow-up at these time-points. Previous studies of patients infected with SARS-CoV-1 in 2003 at PWH showed that significant numbers of recovering patients had impaired long-term health status. It is important to see if these same problems also afflict patients infected with the SARS-CoV-2 virus (the novel coronavirus which causes COVID-19).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Nearly two million cases have been documented, and thousands have died of the 2019 coronavirus disease (COVID-19). Hong Kong has seen nearly 1,000 documented cases of COVID-19 as of April 11, 2020. Potentially many more cases have gone unreported. The virus that causes the COVID-19 disease, SARS-CoV2, is a coronavirus, from the same group of viruses as the SARS virus from 2003. Worldwide, COVID-19 has killed many more patients than SARS, yet the two viruses share a similar background.

As the peak of viral infections begins to recede, however, the main priority will shift to the process of recovery. Over the past 17 years, Professor David SC HUI has published multiple follow-up examinations of SARS patients conducted at the Prince of Wales Hospital (PWH) outpatient clinics. He found that SARS patients suffered serious long-term effects after ostensibly recovering from their illnesses. Moreover, healthcare workers, who were disproportionately affected by SARS infections in 2003 were also disproportionately affected by long-term disability. Like SARS, many COVID-19 patients require intensive care, intubation, and aggressive medical therapy. One of the treatments tried for SARS patients was high-dose corticosteroids, which has been associated with avascular necrosis of major joints and long term disability. As the COVID-19 pandemic only started a few months ago, it is still unknown if COVID-19 patients will suffer the same fate as SARS survivors.

Recent COVID-19 research has logically focused on the acute diagnosis and treatment of affected patients in order to avoid short -term morbidity and mortality. Past research looking at SARS outcomes showed that both the six month exercise capacity and health status of SARS survivors was lower than that of normal controls. Sepsis patients also experience serious disease caused by infection, and long-term reductions in quality of life have been described in survivors of sepsis. Patients who survive intensive care go on to show deficits in verbal learning and memory, resulting in limitations in returning to work or school. Many SARS survivors developed post-traumatic stress disorder and other debilitating psychological illnesses. Based on the Hong Kong experience with SARS, the investigators are concerned that COVID-19 survivors are at risk for similar challenges in quality of life after discharge from acute care.

The Accident and Emergency Medicine Academic Unit of the Chinese University of Hong Kong based at PWH has worked on multiple studies involving quality of life. In particular, the investigators have previously collaborated with Professor Hui and the CUHK Department of Medicine and Therapeutics (M&T) on a quality of life follow-up study on SARS patients. As for studying health related quality of life, the investigators currently have an ongoing project examining the subject in trauma patients after discharge.

Several instruments have been widely used in quality of life research, including the 36-Item Short Form Health Survey (SF-36), the 12-Item Short Form Health Survey (SF-12), the World Health Organization Quality of Life Instruments (WHOQOL-BREF), EuroQoL-5D (EQ-5D-5L) and the Short-Form Six-Dimension (SF-6D). Our team has experience using the SF-36, SF-12v2(HK) and the EQ-5D-5L survey instruments for monitoring quality of life in research subjects in Hong Kong. For example, the investigators found that trauma patients in Hong Kong scored significantly worse on the SF-36 twelve months after injury. The investigators also found the most dramatic improvements happened in the first one to six months post-injury, and that 45% of subjects had achieved an excellent outcome by four years post-injury. The SF-12v2(HK) with four week recall is a modified version of the SF-36 to be shorter and quicker to use, while also already translated and validated in Hong Kong. The investigators aim to combine our experience with conducting quantitative quality of life studies with the CUHK Department of M&T's expertise in coronavirus treatment and followup to explore the quality of life of COVID-19 patients in recovery.

The reported mortality rates for COVID-19 has so far been lower than SARS, although the higher absolute numbers of COVID-19 patients mean worldwide deaths are overall much higher. Trauma, sepsis and SARS survivors have all experienced significant long-term morbidity and decreased quality of life as a result of their injuries or infections. A previous study of patients infected with SARS-CoV-1 in 2003 at PWH showed that significant numbers of recovering patients had impaired long-term health status. The question this study hopes to answer is to what degree do COVID-19 patients suffer a similar fate? Has the knowledge gained from the SARS experience led to improved quality of life outcomes compared to SARS survivors? Or do the similarities between the viruses that cause SARS and COVID-19 extend to a reduced quality of life after recovery as well?

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

As of April 10, 2020, in the NTEC Hospital Authority cluster there have been 89 patients admitted to PWH (of which 17 patients have already been discharged) and 117 admitted to United Christian Hospital with 42 discharged so far.22 Both PWH and United Christian Hospital's COVID-19 patients will follow-up at the PWH infectious diseases specialist outpatient follow-up clinic. Based on prior studies at PWH with SARS patients, approximately 80% agreed to participate in follow-up studies, so we will likely enroll approximately 200 COVID-19 patients.

Description

Inclusion Criteria:

  • All adult patients aged ≥18 years who present to the infectious disease follow-up clinic at PWH will be screened for inclusion in this study. The inclusion criteria are age ≥18 years, laboratory-confirmed COVID-19 infection with SARS-CoV-2, and patients who agree to follow-up for up to six months following their first interview.

Exclusion Criteria:

  • Patients aged below 18 years will be excluded.
  • Patients will be excluded if they meet ANY of the following criteria:
  • Patients or their next of kin are unable to communicate in Chinese or English,
  • Unwilling or unable to provide written informed consent,
  • or Patients who will not be available for telephone follow-up at the scheduled times.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19 Survivors
Patients following-up at the PWH outpatient clinics will be enrolled for further evaluation via telephone follow-up at one, three, and six months after hospital discharge. SF12, EQ-5D-5L and work status standardized quantitative assessments of quality of life will be implemented via telephone follow-up at these time-points.
Other: SF12, EQ-5D-5L and work status standardized quantitative assessments
Quality of life assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six-month SF-12v2(HK) Scores
Time Frame: July 1, 2020-January 31, 2021
The primary outcome measure will be the health summary scores from Short Form Health Survey version 2 Hong Kong (SF-12v2(HK)) in COVID patients at six-months post-discharge from hospital.
July 1, 2020-January 31, 2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six-month EQ-5D-5L Scores
Time Frame: July 1, 2020-January 31, 2021
The secondary outcome measures will include the health status measures of the EuroQuality of Life Five Dimensions (EQ-5D-5L) at six-months.
July 1, 2020-January 31, 2021
One-month SF-12v2(HK)
Time Frame: July 1, 2020-January 31, 2021
The secondary outcome measures will include the health status measures of the Short Form Health Survey version 2 Hong Kong (SF-12v2(HK)) at one-month.
July 1, 2020-January 31, 2021
One-month EQ-5D-5L Scores
Time Frame: July 1, 2020-January 31, 2021
The secondary outcome measures will include the health status measures of the EuroQuality of Life Five Dimensions (EQ-5D-5L) at one-month.
July 1, 2020-January 31, 2021
Three-month SF-12v2(HK) Scores
Time Frame: July 1, 2020-January 31, 2021
The secondary outcome measures will include the health status measures of the Short Form Health Survey version 2 Hong Kong (SF-12v2(HK)) at three-months.
July 1, 2020-January 31, 2021
Three-month EQ-5D-5L Scores
Time Frame: July 1, 2020-January 31, 2021
The secondary outcome measures will include the health status measures of the EuroQuality of Life Five Dimensions (EQ-5D-5L) at three-months.
July 1, 2020-January 31, 2021
One, Three and Six-month Return to Work Status
Time Frame: July 1, 2020-January 31, 2021
Return to work status in COVID patients at one, three and six-months post discharge from hospital.
July 1, 2020-January 31, 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Joseph Walline, MD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 5, 2020

Primary Completion (Anticipated)

April 30, 2021

Study Completion (Anticipated)

April 30, 2022

Study Registration Dates

First Submitted

May 4, 2020

First Submitted That Met QC Criteria

May 4, 2020

First Posted (Actual)

May 6, 2020

Study Record Updates

Last Update Posted (Actual)

May 6, 2020

Last Update Submitted That Met QC Criteria

May 4, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTEC-2020-0227

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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