Skip to main content
OpenTrials
Completed

NCT Number: NCT05303103

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Virus Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

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

    Time frame: After 3 months.

    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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Min-Sheng General Hospital
  • National Yang Ming Chiao Tung University Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 31, 2022
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.