Long COVID and Its Associations With Health Outcomes in Older Adults

COVID-19 Pandemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05825651
• Other study ID #: NNSF72211540398
• Status: Recruiting
• Start date: April 24, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: June 2023
• Source: Peking University
• Contact: Jue Liu, Ph.D
• Phone: +86 13426455743
• Email: jueliu[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: August 31, 2026
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic
• Elderly Infection
• Lifestyle Factors
• Long COVID
• Vaccine Reaction

Intervention

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

Locations

Country	Name	City	State
China	Anning medical community	Kunming	Yunan

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.