Using Mixed-methods Approach to Explore the Long-term Effects of COVID-19

Using Mixed-methods Approach to Explore the Long-term Effects of COVID-19: Presentations, Associating Factors, and Survivor Experience

Researchers warned that up to 80% of the survivors may experience multiple and severe long-term symptoms, sometimes called Long Coronavirus Disease(Long COVID). These Long COVID can persist for longer than three months and cause profound distress and life interferences.

The specific aims are to (1) integrate the state of science of Long COVID, (2) describe the changes of various symptoms and HRQOL(Health-related Quality of Life) after 3, 6, 9, and 12 months of COVID-19 diagnosis, (3) explore predicting factors of the existence and severity of Long COVID, and (4) explore how patient experienced COVID-19 symptoms.

It is a mixed-methods research project with embedded design. Among the three research stages, a systematical review will be conducted first to address aim one. In stage two, a longitudinal cohort study will be carried out to recruit and follow up with individuals diagnosed with COVID-19 for a year. During the follow-up, the participants will need to report their symptoms via online questionnaire, phone or video interviews. Those who did experience COVID-19 symptoms will be invited to join stage three study. Stage three is a qualitative descriptive study addressing aim 4.

Participants and recruitment. For stage two, the inclusion criteria are individuals who (1) are at least 20 years-old and (2) were diagnosed with COVID-19 within six months. Individuals who have cognitive impairment or other issues that prevents them from doing self-ratings of symptoms will be excluded.

Expecting outcomes. It is expected that Long COVID will pose huge burden on survivors and their families. This project can provide a solid reference to foresee possible problems in this population and formulate strategies for early detection and management.

Study Overview

• Status: Completed
• Conditions: Covid19

Detailed Description

Background. When the COVID-19 pandemic sustains for more than a year, a growing number of COVID-19 survivors have returned to their community. However, researchers warned that up to 80% of the survivors may experience multiple and severe long-term symptoms, sometimes called Long COVID, even the subjects were asymptomatic or only had mild symptoms at diagnosis. These Long COVID can persist for longer than three months and cause profound distress and life interferences. Findings from studies and patient reports on social media suggest that various symptoms may be experienced, including fatigue, neurological symptoms, respiratory symptoms, and cardiovascular symptoms. With that being said, more areas, such as how Long COVID evolved after diagnosis, how investigators identify risk groups, and what are these survivors' needs, remain unclear. Aim. The overarching goal of this research project is to investigate the presentations and associating factors regarding Long COVID, and to explore survivor experience. The specific aims are to (1) integrate the state of science of Long COVID, (2) describe the changes of various symptoms and HRQOL after 3, 6, 9, and 12 months of COVID-19 diagnosis, (3) explore predicting factors of the existence and severity of Long COVID, and (4) explore how patient experienced COVID-19 symptoms. Design. It is a mixed-methods research project with embedded design. Among the three research stages, a systematical review will be conducted first to address aim one. In stage two, a longitudinal cohort study will be carried out to recruit and follow up with individuals diagnosed with COVID-19 for a year. During the follow-up, the participants will need to report their symptoms via online questionnaire, phone or video interviews (aim 2 and 3). Those who did experience COVID-19 symptoms will be invited to join stage three study. Stage three is a qualitative descriptive study addressing aim 4. Participants and recruitment. For stage two, the inclusion criteria are individuals who (1) are at least 20 years-old and (2) were diagnosed with COVID-19 within six months. Individuals who have cognitive impairment or other issues that prevents them from doing self-ratings of symptoms will be excluded. Potential participants will be identified through recruitment messages posting on social media and referrals from collaborating healthcare providers. Expecting outcomes. It is expected that Long COVID will pose huge burden on survivors and their families. This project can provide a solid reference to foresee possible problems in this population and formulate strategies for early detection and management. It is one of the few, if there is any, longitudinal study following up with COVID-19 survivors and including patients' perspectives.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

• Study Contact: Name: CHIA CHUN TANG, PhD; Phone Number: 88436 +886-2312-3456; Email: chiatang@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Potential subjects will be identified through the following strategies: (1) searching the intranet of participating medical institutions (e.g., National Taiwan University Hospital, National Yang Ming Chiao Tung University Hospital and Min-Sheng General Hospital), (2) recruitment messages posting on social media, and (3) referrals from collaborating healthcare providers.

Description

Inclusion Criteria:

• at least 20 years-old
• diagnosed with COVID-19 within six months

Exclusion Criteria:

• are still in the active phase of COVID-19 infection (i.e., diagnosed within 4 weeks)
• have cognitive impairment or other issues that prevents them from doing self-ratings of symptoms via phone interviews

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
By exploring the predicting factors, individuals with high-risk of developing severe Long COVID can be identified and targeted early.	The investigators propose to use the combination of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-core model (Taiwan Chinese version) and Quality of Life Questionnaire-Lung Cancer model (Taiwan Chinese version) to measure Long COVID symptoms. It consists of 30 items and measures patients' functions and symptoms by 4-point Likert scales, it also measures quality-of-life by 7-point Likert scale. While the lung cancer model consists of 29 items, the sub-scales of 'fear of progression (2 items)' and 'surgery-related problems (5 items)' will not be used as they are related to cancer progression and treatment. A 4-point Likert scale will rate the remanding 22 items in this study to measure additional symptoms. Higher scores for symptom scales represent more intense symptoms while higher scores for function scales and quality of life mean better function and quality level.	After 3 months of COVID-19 diagnosis.
By exploring the predicting factors, individuals with high-risk of developing severe Long COVID can be identified and targeted early.	The investigators propose to use the combination of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-core model (Taiwan Chinese version) and Quality of Life Questionnaire-Lung Cancer model (Taiwan Chinese version) to measure Long COVID symptoms. It consists of 30 items and measures patients' functions and symptoms by 4-point Likert scales, it also measures quality-of-life by 7-point Likert scale. While the lung cancer model consists of 29 items, the sub-scales of 'fear of progression (2 items)' and 'surgery-related problems (5 items)' will not be used as they are related to cancer progression and treatment. A 4-point Likert scale will rate the remanding 22 items in this study to measure additional symptoms. Higher scores for symptom scales represent more intense symptoms while higher scores for function scales and quality of life mean better function and quality level.	After 6 months of COVID-19 diagnosis.
By exploring the predicting factors, individuals with high-risk of developing severe Long COVID can be identified and targeted early.	The investigators propose to use the combination of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-core model (Taiwan Chinese version) and Quality of Life Questionnaire-Lung Cancer model (Taiwan Chinese version) to measure Long COVID symptoms. It consists of 30 items and measures patients' functions and symptoms by 4-point Likert scales, it also measures quality-of-life by 7-point Likert scale. While the lung cancer model consists of 29 items, the sub-scales of 'fear of progression (2 items)' and 'surgery-related problems (5 items)' will not be used as they are related to cancer progression and treatment. A 4-point Likert scale will rate the remanding 22 items in this study to measure additional symptoms. Higher scores for symptom scales represent more intense symptoms while higher scores for function scales and quality of life mean better function and quality level.	After 9 months of COVID-19 diagnosis.
By exploring the predicting factors, individuals with high-risk of developing severe Long COVID can be identified and targeted early.	The investigators propose to use the combination of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-core model (Taiwan Chinese version) and Quality of Life Questionnaire-Lung Cancer model (Taiwan Chinese version) to measure Long COVID symptoms. It consists of 30 items and measures patients' functions and symptoms by 4-point Likert scales, it also measures quality-of-life by 7-point Likert scale. While the lung cancer model consists of 29 items, the sub-scales of 'fear of progression (2 items)' and 'surgery-related problems (5 items)' will not be used as they are related to cancer progression and treatment. A 4-point Likert scale will rate the remanding 22 items in this study to measure additional symptoms. Higher scores for symptom scales represent more intense symptoms while higher scores for function scales and quality of life mean better function and quality level.	After 12 months of COVID-19 diagnosis.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enhance our understanding toward patient experience and can be used to design more patient- or family-centered care.	Investigators want to provide a fundamental and straightforward description regarding the survivors' symptoms and experiences. The qualitative results based on patient perspectives may provide a reference for selecting appropriate strategies of observing and documenting Long COVID.	After 3 months.

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Min-Sheng General Hospital; National Yang Ming Chiao Tung University Hospital
• Investigators: Principal Investigator: Chia Chun Tang, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2021
• Primary Completion (Actual): June 24, 2023
• Study Completion (Actual): June 24, 2023

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: health-related quality of life; long-term effects; mixed-methods; longitudinal cohort study; Severe acute respiratory syndrome-coronavirus
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 202106071RINB

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