Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT05825651
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-12
First Post:
2023-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long COVID and Its Associations With Health Outcomes in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000084063', 'term': 'Reinfection'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012008', 'term': 'Recurrence'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11527}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-07', 'studyFirstSubmitDate': '2023-03-26', 'studyFirstSubmitQcDate': '2023-04-21', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of long COVID', 'timeFrame': 'From baseline until the date of long COVID symptoms or date of death from any cause, whichever came first, assessed up to 12 months.', 'description': 'The proportion of participants incurred any symptoms or diagnosed diseases of post-COVID in all infected participants.'}], 'secondaryOutcomes': [{'measure': 'Reinfection incidence of COVID-19', 'timeFrame': 'At 3 months, 6 months, 9 months, 1 year after baseline investigation.', 'description': 'The proportion of participants infected by COVID-19 at least 2 times. Measured by trained health professionals.'}, {'measure': 'Cognitive impairment', 'timeFrame': 'At 3 months, 6 months, 9 months, 1 year after baseline investigation.', 'description': '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.'}, {'measure': 'Depression', 'timeFrame': 'At 3 months, 6 months, 9 months, 1 year after baseline investigation.', 'description': '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.'}, {'measure': 'Medical expenditure', 'timeFrame': 'At 3 months, 6 months, 9 months, 1 year after baseline investigation.', 'description': 'Measured by health professionals using self-designed questionnaire about their past month outpatient expenditure and past year inpatient expenditure.'}, {'measure': 'Incidence of catastrophic health expenditure', 'timeFrame': 'At 3 months, 6 months, 9 months, 1 year after baseline investigation.', 'description': "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."}, {'measure': 'Sleep quality', 'timeFrame': 'At 3 months, 6 months, 9 months, 1 year after baseline investigation.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Long COVID', 'COVID-19 Pandemic', 'Elderly Infection', 'Vaccine Reaction', 'Lifestyle Factors', 'Reinfection']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Older adults aged at least 60 years old living in Anning, Yunnan, China', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. ≥60 years\n* 2\\. Resided in Anning in the past half year and have no plan to move out in next 1 year\n* 3\\. Older adults who are willing to participate in this study with informed consent\n\nExclusion Criteria:\n\n* 1\\. Unable to answer questions or communicate\n* 2\\. Older adults who are not willing to participate in this study or without informed consent'}, 'identificationModule': {'nctId': 'NCT05825651', 'briefTitle': 'Long COVID and Its Associations With Health Outcomes in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'A Prospective Cohort Study for Long COVID and Health Outcomes in Older Adults in Yunnan, China', 'orgStudyIdInfo': {'id': 'NNSF72211540398'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exposure group', 'description': 'Group with history of COVID-19 infections and vaccines, as well as health-related, behavioral, socioeconomic exposures.', 'interventionNames': ['Other: no interventions']}, {'label': 'Non-exposure group', 'description': 'Group without history of COVID-19 infections and vaccines, as well as health-related, behavioral, socioeconomic exposures.'}], 'interventions': [{'name': 'no interventions', 'type': 'OTHER', 'description': 'This is an observational study without any intervention.', 'armGroupLabels': ['Exposure group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kunming', 'state': 'Yunan', 'country': 'China', 'facility': 'Anning medical community', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}], 'overallOfficials': [{'name': 'Jue Liu, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Natural Science Foundation of China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Liu Jue', 'investigatorAffiliation': 'Peking University'}}}}