Covid19NCT05303103
Using Mixed-methods Approach to Explore the Long-term Effects of COVID-19
An observational study of Covid19, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Covid19
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Nov 2021to 24 Jun 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- at least 20 years-old
- diagnosed with COVID-19 within six months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Covid19
- Keywords
- Severe acute respiratory syndrome-coronavirus, long-term effects, mixed-methods, health-related quality of life, longitudinal cohort study
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: After 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start18 Nov 2021
- Primary completion24 Jun 2023
- Study completion24 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 150 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Min-Sheng General Hospital, National Yang Ming Chiao Tung University Hospital
- Responsible party
- Sponsor
- Investigators
- Chia Chun Tang, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303103
- Sponsor's protocol ID
- 202106071RINB
- Status last verified
- Jun 2023
- First submitted
- 2 Dec 2021
- Last updated
- 28 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40084807
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Mixed-methods Approach to Explore the Long-term Effects of COVID-19: Presentations, Associating Factors, and Survivor Experience
- ClinicalTrials.gov ID
- NCT05303103
- Acronym / sponsor ID
- 202106071RINB
- Conditions
- Covid19
- Keywords
- Severe acute respiratory syndrome-coronavirus, long-term effects, mixed-methods, health-related quality of life, longitudinal cohort study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Min-Sheng General Hospital, National Yang Ming Chiao Tung University Hospital
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 24 Jun 2023 (actual)
- Study completion
- 24 Jun 2023 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- at least 20 years-old
- diagnosed with COVID-19 within six months
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
By exploring the predicting factors, individuals with high-risk of developing severe Long COVID can be identified and targeted early.
Time frame: After 3 months of COVID-19 diagnosis.
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.
By exploring the predicting factors, individuals with high-risk of developing severe Long COVID can be identified and targeted early.
Time frame: After 6 months of COVID-19 diagnosis.
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.
By exploring the predicting factors, individuals with high-risk of developing severe Long COVID can be identified and targeted early.
Time frame: After 9 months of COVID-19 diagnosis.
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.
By exploring the predicting factors, individuals with high-risk of developing severe Long COVID can be identified and targeted early.
Time frame: After 12 months of COVID-19 diagnosis.
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.
1 secondary outcome
Enhance our understanding toward patient experience and can be used to design more patient- or family-centered care.
Time frame: After 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Derived from this study: PubMed 40084807Tang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia Chun Tang, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
By exploring the predicting factors, individuals with high-risk of developing severe Long COVID can be identified and targeted early. (time frame: After 3 months of COVID-19 diagnosis.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05303103, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023; AzTrials last refreshed its copy on 28 Oct 2026.