Clinical trial NCT05303103: Using Mixed-methods Approach to Explore the Long-term Effects of COVID-19
Official title: Using Mixed-methods Approach to Explore the Long-term Effects of COVID-19: Presentations, Associating Factors, and Survivor Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Severe acute respiratory syndrome-coronavirus
long-term effects
mixed-methods
health-related quality of life
longitudinal cohort study
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Min-Sheng General Hospital
name: National Yang Ming Chiao Tung University Hospital
First posted: 2022-03-31
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: By exploring the predicting factors, individuals with high-risk of developing severe Long COVID can be identified and targeted early.
timeFrame: After 3 months of COVID-19 diagnosis.
measure: By exploring the predicting factors, individuals with high-risk of developing severe Long COVID can be identified and targeted early.
timeFrame: After 6 months of COVID-19 diagnosis.
measure: By exploring the predicting factors, individuals with high-risk of developing severe Long COVID can be identified and targeted early.
timeFrame: After 9 months of COVID-19 diagnosis.
measure: By exploring the predicting factors, individuals with high-risk of developing severe Long COVID can be identified and targeted early.
timeFrame: After 12 months of COVID-19 diagnosis.
Secondary outcomes:
measure: Enhance our understanding toward patient experience and can be used to design more patient- or family-centered care.
timeFrame: After 3 months.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chia Chun Tang, PhD
role: PRINCIPAL_INVESTIGATOR
References: