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Active, Not Recruiting

NCT Number: NCT05825651

Long COVID and Its Associations With Health Outcomes in Older Adults

The Peking University Health Cohort in Anning, Yunnan (PKUHC-AN) is a prospective cohort study carried out in Anning, Yunnan. The primary aim of this study is to investigate the impact of COVID-19 on older adults' health, and to provide high-quality evidence of real world research for the optimization of prevention and control strategies of COVID-19 and other emerging infectious diseases. Data will be collected regarding health status, history of COVID-19 infections and vaccines, lifestyle and socioeconomic characteristics, as well as the short- and long-term health outcomes.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Long COVID COVID-19 COVID-19 Pandemic Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Elderly Infection Infections Lifestyle Factors Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Recurrence Reinfection Respiratory Tract Diseases Respiratory Tract Infections Vaccine Reaction Virus Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Anning medical community

Kunming, Yunan, China

About this study

COVID-19 pandemic attributed to a great number of mortalities around the world in the last 3 years. About 46% of the global population are estimated to have been infected by the omicron variant and its sublineages. Health outcomes post COVID-19 has been of great concern globally since more and more people infected by SARS-CoV-2. Integrated efforts should be made to estimate the incidence of reinfections and long COVID in China, especially among older adults who are vunlerable and susceptible to COVID-19. In view of this, the Peking University Health Cohort Study in Anning, Yunnan aims to investigate the impact of COVID-19 on older adults' health, and to provide high-quality evidence of real world research for the optimization of prevention and control strategies of COVID-19 and other emerging infectious diseases. Data will be collected regarding health status, history of COVID-19 infections and vaccines, lifestyle and socioeconomic characteristics, as well as the short- and long-term health outcomes.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 1. ≥60 years
  • 2. Resided in Anning in the past half year and have no plan to move out in next 1 year
  • 3. Older adults who are willing to participate in this study with informed consent

Exclusion criteria

  • 1. Unable to answer questions or communicate
  • 2. Older adults who are not willing to participate in this study or without informed consent

Treatment and study plan

No interventions

Other

This is an observational study without any intervention.

Primary outcomes

  1. Incidence of long COVID

    Time frame: From baseline until the date of long COVID symptoms or date of death from any cause, whichever came first, assessed up to 12 months.

    The proportion of participants incurred any symptoms or diagnosed diseases of post-COVID in all infected participants.

Secondary outcomes

  1. Reinfection incidence of COVID-19

    Time frame: At 3 months, 6 months, 9 months, 1 year after baseline investigation.

    The proportion of participants infected by COVID-19 at least 2 times. Measured by trained health professionals.

  2. Cognitive impairment

    Time frame: At 3 months, 6 months, 9 months, 1 year after baseline investigation.

    Measured by health professionals using MMSE (Mini-Mental State Exam). The MMSE cognitive screening test is a 30-point questionnaire for analyzing several cognitive functions including memory, orientation, attention, calculation, and language. MMSE is measured on a scale between 0 and 30, where scores of 0-9, 10-20, 21-26, and 27-30 indicate severe, moderate, mild, and normal cognitive function, respectively.

  3. Depression

    Time frame: At 3 months, 6 months, 9 months, 1 year after baseline investigation.

    Measured by health professionals using PHQ-9 (Patient Health Questionnaire-9). PHQ-9 provides a score ranging from 0 to 27, where scores of <4, 5-9, 10-14, 15-19, and 20-27 represented no, mild, moderate, moderately severe, and severe depression, respectively.

  4. Medical expenditure

    Time frame: At 3 months, 6 months, 9 months, 1 year after baseline investigation.

    Measured by health professionals using self-designed questionnaire about their past month outpatient expenditure and past year inpatient expenditure.

  5. Incidence of catastrophic health expenditure

    Time frame: At 3 months, 6 months, 9 months, 1 year after baseline investigation.

    Measured by health professionals using self-designed questionnaire about their households' past year consumption expenditure (including food expenditure, cloths expenditure, transportation expenditure and so on), and calculated as the proportion of households whose out-of-pocket medical expenditure exceed 40% of household non-food expenditure.

  6. Sleep quality

    Time frame: At 3 months, 6 months, 9 months, 1 year after baseline investigation.

    Measured by health professionals using PSQI (Pittsburgh Sleep Quality Index). PSQI reflects sleep for a month, includes 18 items (7 subscales): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime dysfunction. The range of PSQI global score is 0-21, and a score of >5 or 7 is indicative of poor sleep quality.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Official study title

A Prospective Cohort Study for Long COVID and Health Outcomes in Older Adults in Yunnan, China

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2023
Registry last updated
Dec 12, 2024

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.

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