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

NCT05303103 | Completed

• 1 other identifier: 202106071RINB
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19

Keywords

Severe acute respiratory syndrome-coronavirus; long-term effects; mixed-methods; health-related quality of life; longitudinal cohort study

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Enhance our understanding toward patient experience and can be used to design more patient- or family-centered care.

  After 3 months.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Min-Sheng General Hospital: collaborator
• National Yang Ming Chiao Tung University Hospital: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

• Tang CC, Wu WW, Ho SJ, Liu WD, Pan MY, Chang SC, Wang WS, Yeh YC, Chen CH, Chang JC. Clinically Significant Functional Impairments and Symptoms in COVID-19 Survivors: Empirical Research Quantitative. J Clin Nurs. 2025 Nov;34(11):4664-4672. doi: 10.1111/jocn.17715. Epub 2025 Mar 14.

  PMID: 40084807 DERIVED

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Chia Chun Tang, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: March 31, 2022
• Study Start: November 18, 2021
• Primary Completion: June 24, 2023
• Study Completion: June 24, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)