Shanghai Pudong Natural Population-based Cohort Establishment and Follow-up

Sponsor
RenJi Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05206643
Collaborator
Jinqiao Community Health Service Center of Pudong new area, Shanghai (Other), Heqing Community Health Service Center of Pudong new area, Shanghai (Other), Weifang Community Health Service Center of Pudong new area, Shanghai (Other), Jinyang Community Health Service Center of Pudong new area, Shanghai (Other)
80,000
1
76.8
1041.5

Study Details

Study Description

Brief Summary

Our objective is to establish a natural population-based cohort in East China based on the latest scientific researches, preliminary findings of the project team, and a close cooperation model of the Specialist Medical Consortium.

We will focus on the information and management of health status of the general population of all ages. We plan to integrate the questionnaire data and sample database information into the public "co-prevention and management" information platform, in order to establish an whole health management system.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Evidence-based public health approaches to prevent various chronic diseases among population of all ages have been confirmed in recent decades. Yet barriers to implement prevention approaches persist as a result of lack of knowledge about the regularity of changes in health status of people of all ages. The purpose of this study was to learn how best to promote the adoption of evidence based public health practice related to chronic disease prevention. The whole research plan is based on a combination of retrospective, cross-sectional, and prospective cohort studies.

    In particular, the retrospective cohort study collects historical information of the studied cohort from 2014 to 2018 from secondary medical units, residents' community health service centers, emergency departments, and their health records. Patients' past chronic diseases such as atherosclerotic cardiovascular diseases, cancers, hypertension, diabetes, heart failure, atrial fibrillation, metabolic syndrome and other metabolic diseases, information on the history of drug use, and lifestyle (if any) are collected and sorted out. Moreover, information on various chronic disease morbidity and death among members of the cohort is collected.

    The cross-sectional study builds on the baseline research conducts during 2019-2020.

    Specifically, baseline research contains the following procedures:
    1. Epidemiological survey: Design the Cardio-Cerebrovascular Disease Prevention and Control Questionnaire in accordance with the principles and requirements of the cohort study. On the premise of informed notification, data are collected through face-to-face interviews between the studied cohort and investigators who signed the informed consent and received uniform training. Quality control staff will review the questionnaire for quality control. The main content includes demographic sociology, lifestyle, physical exercise, daily eating habits, usage of dietary supplements, personal and family medical history, psychological assessment, and female fertility history.

    2. Physical examination: the examination is performed by the clinical professional physician in the health service center. The examination content includes height, weight, blood pressure, hearing, vision, internal surgery, body fat composition (optional), chest radiography, electrocardiogram, B-ultrasound, carotid ultrasound (optional), and other imaging examinations.

    3. Clinical biochemical test: fasting blood collection should be performed by all individuals upon their enrollment. The blood samples collected are tested for biochemistry, liver and kidney function, blood lipid analysis, and electrolyte analysis in accordance with clinical testing requirements.

    4. Biological specimen collection: collect 10ml ethylenediaminetetraacetic acid blood samples using a health checkup, then send them to Renji sample bank for separation within 2 hours, and store in -80℃ ultra-low temperature refrigerator.

    Lastly, the prospective study will be conducted from 2020 to 2025. Through annual active (phone, face-to-face interview, etc.) and passive follow-ups, we will collect the information and management of health status of the general population of all ages. Meanwhile, we will track the various chronic diseases occurrence, death, migration, etc. in our cohort. And we will collect data that matches its baseline value, analyze the morbidity and mortality of the cohort population, and grasp the morbidity, the order of the diseases, mortality, and order of the cause of death for each disease.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Shanghai Pudong Natural Population-based Cohort Establishment and Follow-up
    Actual Study Start Date :
    Aug 7, 2019
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    Dec 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Health Status of the General Population [5 years]

      Survey on the general health of the nation in a specific time

    2. Incidence of common chronic diseases [5 years]

      Incidence of common chronic diseases including atherosclerotic cardiovascular diseases, cancers, heart failure, hypertension, atrial fibrillation, type II diabetes, metabolic syndrome and other metabolic diseases were calculated by age, gender and area compared by different health management mode.

    3. Mortality of common chronic diseases [5 years]

      Mortality of common chronic diseases including atherosclerotic cardiovascular diseases, cancers, heart failure, hypertension, atrial fibrillation, type II diabetes, metabolic syndrome and other metabolic diseases were calculated by age, gender and area compared by different health management mode.

    Secondary Outcome Measures

    1. Normalized management rate of common chronic diseases [5 years]

      Normalized management rate of common chronic diseases

    2. Health questionnaire [5 years]

      General health questionnaire including questions about chronic diseases, lifestyle, access to health services, comorbidities, mental health, smoke, alcohol and drugs consumption. Additional questions regarding more specific themes (ASCVD, medical aid in dying, COVID-19, etc.) will be added or adapted yearly. Most of the questions are individually based on previously accepted or previously used questionnaires and thus, the health questionnaire used in this project does not include a specific scale of measurement for each subjects.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    All the selected samples were to be interviewed.

    Exclusion Criteria:

    severely ill or too frail to answer; having cognitive problems; having hearing or speaking problems; or dementia.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cardiology, Ren Ji Hospital Shanghai China

    Sponsors and Collaborators

    • RenJi Hospital
    • Jinqiao Community Health Service Center of Pudong new area, Shanghai
    • Heqing Community Health Service Center of Pudong new area, Shanghai
    • Weifang Community Health Service Center of Pudong new area, Shanghai
    • Jinyang Community Health Service Center of Pudong new area, Shanghai

    Investigators

    • Principal Investigator: Jun Pu, MD,PhD, Cardiology, Ren Ji Hospital, Shanghai, China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT05206643
    Other Study ID Numbers:
    • Shanghai Pudong Cohort
    First Posted:
    Jan 25, 2022
    Last Update Posted:
    Aug 10, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by RenJi Hospital

    Study Results

    No Results Posted as of Aug 10, 2022