Long COVIDNCT05825651
Long COVID and Its Associations With Health Outcomes in Older Adults
An observational study of Long COVID and COVID-19 Pandemic, run by Peking University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Long COVID, COVID-19 Pandemic, Elderly Infection
- Type of treatment
- Vaccines
- How many people
- 11,527 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2023to 31 Aug 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Older adults aged at least 60 years old living in Anning, Yunnan, China
Who may be able to join
- 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
Who cannot join
- 1. Unable to answer questions or communicate
- 2. Older adults who are not willing to participate in this study or without informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Long COVID, COVID-19 Pandemic, Elderly Infection, Vaccine Reaction, Lifestyle Factors, Reinfection
- Being tested
- no interventions
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19, Reinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionsOther
This is an observational study without any intervention.
| Study group | Role | What they receive |
|---|---|---|
| Exposure group | Group with history of COVID-19 infections and vaccines, as well as health-related, behavioral, socioeconomic exposures. Receives: Other: no interventions | |
| Non-exposure group | Group without history of COVID-19 infections and vaccines, as well as health-related, behavioral, socioeconomic exposures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of long COVID
The proportion of participants incurred any symptoms or diagnosed diseases of post-COVID in all infected participants.
Measured: 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 outcomes (6)
Reinfection incidence of COVID-19
The proportion of participants infected by COVID-19 at least 2 times. Measured by trained health professionals.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 3 months, 6 months, 9 months, 1 year after baseline investigation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start24 Apr 2023
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11,527 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Liu Jue, Peking University
- Investigators
- Jue Liu, Ph.D, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825651
- Sponsor's protocol ID
- NNSF72211540398
- Status last verified
- Dec 2024
- First submitted
- 26 Mar 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No