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

NCT05303103 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2023-07-28

No results posted yet for this study

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

Sponsors & Collaborators

  • Min-Sheng General Hospital

    collaborator OTHER

  • National Yang Ming Chiao Tung University Hospital

    collaborator OTHER

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Chia Chun Tang, PhD · National Taiwan University Hospital

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-18
Primary Completion
2023-06-24
Completion
2023-06-24

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05303103 on ClinicalTrials.gov