Long COVID and Its Associations With Health Outcomes in Older Adults

Active, not recruiting

• Conditions: Long COVID; COVID-19 Pandemic; Vaccine Reaction; Lifestyle Factors; Reinfection; Elderly Infection
• Interventions: Other: no interventions

• Registration Number: NCT05825651
• Lead Sponsor: Peking University

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.

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 Timeline

• Study First Submitted: 2023-03-26
• Study First Submitted QC: 2023-04-21
• Study Start: 2023-04-24
• Study First Posted: 2023-04-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-07
• Last Update Posted: 2024-12-12
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 11527

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposure group	no interventions	Group with history of COVID-19 infections and vaccines, as well as health-related, behavioral, socioeconomic exposures.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

Anning medical community; 🇨🇳 Kunming, Yunan, China