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临床试验/NCT06370793
NCT06370793进行中(未招募)不适用

Ningbo Schizophrenia Cohort, a Longitudinal Population-based Ambispective Cohort Study

Ningbo University1 个研究点 分布在 1 个国家目标入组 26,899 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
26,899
试验地点
1
主要终点
Risk of musculoskeletal system diseases

研究概览

简要总结

In recent years, the prevalence of schizophrenia in China has continued to grow, and the burden of disease in society has continued to rise. In order to improve the prognosis of patients with schizophrenia and reduce the risk of disease relapse or readmission, researchers established a cohort based on the Ningbo Mental Health Information System in Ningbo, a sub-provincial city in the southern wing of the Yangtze River Delta of China, with a resident population of more than 9 million, and linked it to the residents' health records, and through the data linkage obtained data on patients in the full cycle of pre-onset, diagnosis, follow-up, disease changes and death, realising full-cycle management of patients with schizophrenia.

Currently, NSC has accumulated data on more than 30,000 patients with schizophrenia and obtained multi-dimensional longitudinal information through long-term follow-up and data linkage. All diseases follow the World Health Organization International Classification of Diseases 10th Edition (ICD-10) for clinical coding, and available data include baseline demographics, past history, family history, social functioning deficit screening scale scores, risk assessment, and so on and longitudinal health information from electronic health records (EHR), providing a solid data base for future real-world studies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of schizophrenia (F20)
  • Aged 18-65 years at the time of diagnosis

排除标准

  • 未提供

结局指标

主要结局

Risk of musculoskeletal system diseases

时间窗: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)

At least one of the following diagnoses in the electronic health records :Connective tissue disorders (M05-M06, M08-M09, M30-M36, D86), Osteoporosis (M80-M82). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.

Risk of violence

时间窗: Recorded during the study period (2019-2023)

At least one of the following records in the Ningbo Mental Health Information System: causing trouble, causing an accident, committing an offence, injuring another person. Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.

Risk of gastrointestinal system diseases

时间窗: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)

At least one of the following diagnoses in the electronic health records : Ulcer/chronic gastritis (K22.1, K25-K28, K29.3-K29.5), Chronic liver disease (B16-B19, K70, K74, K76.6, I85), Inflammatory bowel disease (K50-K51), Diverticular disease of intestine (K57). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.

Risk of hematological system diseases

时间窗: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)

At least one of the following diagnoses in the electronic health records : HIV/AIDS (B20-B24), Anemias (D50-D53, D55-D59, D60-D61, D63-D64). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.

Risk of neurological system diseases

时间窗: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)

At least one of the following diagnoses in the electronic health records :Vision problem (H40, H25, H54), Hearing problem (H90-H91, H93.1), Migraine (G43), Epilepsy (G40-G41), Parkinson's disease (G20-G22), Multiple sclerosis (G35), Neuropathies (G50-G64). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.

Risk of pulmonary system and allergy diseases

时间窗: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)

At least one of the following diagnoses in the electronic health records : Chronic pulmonary disease (J40-J47), Allergy (J30.1-J30.4, L23, L50.0, T78.0, T78.2, T78.4). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.

Risk of urogenital system diseases

时间窗: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)

At least one of the following diagnoses in the electronic health records : Chronic kidney disease (N03, N11, N18-N19), Prostate disorders (N40). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.

Risk of suicide

时间窗: Recorded during the study period (2019-2023)

At least one of the following records in the Ningbo Mental Health Information System: attempted suicide, suicide, death by suicide. Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.

Risk of endocrine system diseases

时间窗: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)

At least one of the following diagnoses in the electronic health records : Diabetes mellitus (E10-E14), Thyroid disorder (E00-E05, E61-E69, E07), Gout (E79, M10). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.

Risk of cancers

时间窗: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)

Diagnosed with cancer (C00-C43, C45-C97) in electronic health records. Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.

Risk of circulatory system diseases

时间窗: At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)

At least one of the following diagnoses in the electronic health records : Primary hypertension (I10), Cerebral infarction (I63), Transient cerebral ischaemic attacks and related syndromes (G45), Intracerebral haemorrhage (I61), Subarachnoid haemorrhage (I60), Hemorrhagic stroke (I60-I61), Stroke (I60-I64, I69), Pulmonary embolism (I26), Aortic aneurysm and dissection (I71), Cardiovascular disease (I20-I25), Atrial fibrillation (I48), Cardiomyopathy (I42), Peripheral vascular diseases (I73), Myocardial infarction (I21-I22), Heart failure (I50). Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.

次要结局

未报告次要终点

研究者

发起方
Ningbo University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Liya Liu

Associate Professor

Ningbo University

研究点 (1)

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