Long COVID and Its Associations With Health Outcomes in Older Adults

Sponsor
Peking University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05825651
Collaborator
National Natural Science Foundation of China (Other)
20,000
1
40
499.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: no interventions

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Cohort Study for Long COVID and Health Outcomes in Older Adults in Yunnan, China
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Exposure group

Group with history of COVID-19 infections and vaccines, as well as health-related, behavioral, socioeconomic exposures.

Other: no interventions
This is an observational study without any intervention.

Non-exposure group

Group without history of COVID-19 infections and vaccines, as well as health-related, behavioral, socioeconomic exposures.

Outcome Measures

Primary Outcome Measures

  1. Incidence of long COVID [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 Outcome Measures

  1. Reinfection incidence of COVID-19 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
    1. ≥60 years
    1. Resided in Anning in the past half year and have no plan to move out in next 1 year
    1. Older adults who are willing to participate in this study with informed consent
Exclusion Criteria:
    1. Unable to answer questions or communicate
    1. Older adults who are not willing to participate in this study or without informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Beijing Beijing China 100191

Sponsors and Collaborators

  • Peking University
  • National Natural Science Foundation of China

Investigators

  • Principal Investigator: Jue Liu, Ph.D, Peking University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Liu Jue, Prof., Peking University
ClinicalTrials.gov Identifier:
NCT05825651
Other Study ID Numbers:
  • NNSF72211540398
First Posted:
Apr 24, 2023
Last Update Posted:
Apr 24, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 24, 2023