COVID-19 - Quality of Life After Infection

COVID-19 Clinical Trial

Official title:

COVID-19 - Quality of Life After Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04377464
• Other study ID #: NTEC-2020-0227
• Status: Not yet recruiting
• Start date: May 5, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2020
• Source: Chinese University of Hong Kong
• Contact: Joseph Walline, MD
• Phone: +852 3505 1033
• Email: jwalline[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Quality of Life

Intervention

Other:
• SF12, EQ-5D-5L and work status standardized quantitative assessments
Quality of life assessments

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

References & Publications (20)

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Chen J, Wong CK, McGhee SM, Pang PK, Yu WC. A comparison between the EQ-5D and the SF-6D in patients with chronic obstructive pulmonary disease (COPD). PLoS One. 2014 Nov 7;9(11):e112389. doi: 10.1371/journal.pone.0112389. eCollection 2014. — View Citation

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Griffith JF, Antonio GE, Kumta SM, Hui DS, Wong JK, Joynt GM, Wu AK, Cheung AY, Chiu KH, Chan KM, Leung PC, Ahuja AT. Osteonecrosis of hip and knee in patients with severe acute respiratory syndrome treated with steroids. Radiology. 2005 Apr;235(1):168-75. Epub 2005 Feb 9. — View Citation

Hui DS, Joynt GM, Wong KT, Gomersall CD, Li TS, Antonio G, Ko FW, Chan MC, Chan DP, Tong MW, Rainer TH, Ahuja AT, Cockram CS, Sung JJ. Impact of severe acute respiratory syndrome (SARS) on pulmonary function, functional capacity and quality of life in a cohort of survivors. Thorax. 2005 May;60(5):401-9. — View Citation

Hui DS. Severe acute respiratory syndrome (SARS): lessons learnt in Hong Kong. J Thorac Dis. 2013 Aug;5 Suppl 2:S122-6. doi: 10.3978/j.issn.2072-1439.2013.06.18. — View Citation

Lam CL, Tse EY, Gandek B. Is the standard SF-12 health survey valid and equivalent for a Chinese population? Qual Life Res. 2005 Mar;14(2):539-47. — View Citation

Li TS, Gomersall CD, Joynt GM, Chan DP, Leung P, Hui DS. Long-term outcome of acute respiratory distress syndrome caused by severe acute respiratory syndrome (SARS): an observational study. Crit Care Resusc. 2006 Dec;8(4):302-8. — View Citation

Li Y, Xia L. Coronavirus Disease 2019 (COVID-19): Role of Chest CT in Diagnosis and Management. AJR Am J Roentgenol. 2020 Mar 4:1-7. doi: 10.2214/AJR.20.22954. [Epub ahead of print] — View Citation

Mak IW, Chu CM, Pan PC, Yiu MG, Ho SC, Chan VL. Risk factors for chronic post-traumatic stress disorder (PTSD) in SARS survivors. Gen Hosp Psychiatry. 2010 Nov-Dec;32(6):590-8. doi: 10.1016/j.genhosppsych.2010.07.007. Epub 2010 Sep 15. — View Citation

Rabiee A, Nikayin S, Hashem MD, Huang M, Dinglas VD, Bienvenu OJ, Turnbull AE, Needham DM. Depressive Symptoms After Critical Illness: A Systematic Review and Meta-Analysis. Crit Care Med. 2016 Sep;44(9):1744-53. doi: 10.1097/CCM.0000000000001811. Review. — View Citation

Rainer TH, Graham CA, Yeung HH, Poon WS, Ho HF, Kam CW, Cameron P. Assessment of long-term functional outcome in patients who sustained moderate or major trauma: a 4-year prospective cohort study. Hong Kong Med J. 2018 Feb;24 Suppl 2(1):30-33. — View Citation

Rainer TH, Hung KKC, Yeung JHH, Cheung SKC, Leung YK, Leung LY, Goggins WB, Ho HF, Kam CW, Cheung NK, Graham CA. Trajectory of functional outcome and health status after moderate-to-major trauma in Hong Kong: A prospective 5 year cohort study. Injury. 2019 May;50(5):1111-1117. doi: 10.1016/j.injury.2019.02.017. Epub 2019 Feb 22. — View Citation

Rainer TH, Yeung JH, Cheung SK, Yuen YK, Poon WS, Ho HF, Kam CW, Cattermole GN, Chang A, So FL, Graham CA. Assessment of quality of life and functional outcome in patients sustaining moderate and major trauma: a multicentre, prospective cohort study. Injury. 2014 May;45(5):902-9. doi: 10.1016/j.injury.2013.11.006. Epub 2013 Nov 21. — View Citation

Semmler A, Widmann CN, Okulla T, Urbach H, Kaiser M, Widman G, Mormann F, Weide J, Fliessbach K, Hoeft A, Jessen F, Putensen C, Heneka MT. Persistent cognitive impairment, hippocampal atrophy and EEG changes in sepsis survivors. J Neurol Neurosurg Psychiatry. 2013 Jan;84(1):62-9. doi: 10.1136/jnnp-2012-302883. Epub 2012 Nov 7. — View Citation

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* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six-month SF-12v2(HK) Scores	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	Six-month EQ-5D-5L Scores	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
Secondary	One-month SF-12v2(HK)	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
Secondary	One-month EQ-5D-5L Scores	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
Secondary	Three-month SF-12v2(HK) Scores	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
Secondary	Three-month EQ-5D-5L Scores	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
Secondary	One, Three and Six-month Return to Work Status	Return to work status in COVID patients at one, three and six-months post discharge from hospital.	July 1, 2020-January 31, 2021

External Links

•   Center for Health Protection G of the HKS. Centre for Health Protection
•   Centre for Health Protection of the Department of Health of the Hong Kong SAR. Countries/Areas with Reported Cases of Coronavirus Disease-2019 (COVID-19).; 2020.
•   World Health Organization. Situation Report-78 HIGHLIGHTS.; 2020