Long COVID and Its Associations With Health Outcomes in Older Adults

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Reinfection; Vaccine Reaction; Long COVID; COVID-19 Pandemic; Elderly Infection; Lifestyle Factors
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 11527

Contacts and Locations

Study Locations

• China
  • Yunan
    • Kunming, Yunan, China
      • Anning medical community

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Older adults aged at least 60 years old living in Anning, Yunnan, China

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of long COVID	The proportion of participants incurred any symptoms or diagnosed diseases of post-COVID in all infected participants.	From baseline until the date of long COVID symptoms or date of death from any cause, whichever came first, assessed up to 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reinfection incidence of COVID-19	The proportion of participants infected by COVID-19 at least 2 times. Measured by trained health professionals.	At 3 months, 6 months, 9 months, 1 year after baseline investigation.
Cognitive impairment	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.	At 3 months, 6 months, 9 months, 1 year after baseline investigation.
Depression	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.	At 3 months, 6 months, 9 months, 1 year after baseline investigation.
Medical expenditure	Measured by health professionals using self-designed questionnaire about their past month outpatient expenditure and past year inpatient expenditure.	At 3 months, 6 months, 9 months, 1 year after baseline investigation.
Incidence of catastrophic health expenditure	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.	At 3 months, 6 months, 9 months, 1 year after baseline investigation.
Sleep quality	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.	At 3 months, 6 months, 9 months, 1 year after baseline investigation.

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: National Natural Science Foundation of China
• Investigators: Principal Investigator: Jue Liu, Ph.D, Peking University

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: March 26, 2023
• First Submitted That Met QC Criteria: April 21, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 7, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Post-Infectious Disorders; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Recurrence; COVID-19; Reinfection; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: NNSF72211540398

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No