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Internet Technology Based Life-style and Care Intervention for Risk Factors of Non Communicable Diseases（NCD）

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ClinicalTrials.gov Identifier: NCT04567121
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
Beijing Tsinghua Chang Gung Hospital

Study Description
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Brief Summary:
This study aims to control risk factors of non communicable diseases by life style and care intervention based on internet technology, looking forward to improve cardiovascular and cerebrovascular complications, diabetes and all-cause death.

Condition or disease Intervention/treatment Phase
Lifestyle Intervention Non Communicable Diseases Behavioral: Intensive intervention group Behavioral: standard intervention group Not Applicable

Detailed Description:

Cardiovascular and cerebrovascular diseases, diabetes, chronic obstructive pulmonary disease and malignant tumors are the main chronic diseases, which have been the most important cause of human death, consuming most health resources. In China, patients with cardiovascular and cerebrovascular diseases account for more than 40% of all causes of death. After half a century of research, we have a thorough understanding of risk factors of cardiovascular disease, including genetics, aging, ethnicity, physical activity decreases, unbalanced nutrition and calorie intake, smoking, obesity, hypertension, dyslipidemia, and glucose abnormalities, etc. Many factors can be corrected through health education, indicating that the occurrence of chronic diseases can be prevented through lifestyle changes and the control of risk factors.

This project collects risk factors of cardiovascular disease and establishes a real and reliable health database by conducting a cross-sectional survey of chronic diseases among residents of Tian Tong Yuan District (there are hundreds of thousands of people).On this basis, community health management network was established with internet technology. Meanwhile, prospective, open, community randomized and controlled lifestyle intervention studies were carried out. Intervention was conducted on risk factors of cardiovascular and cerebrovascular diseases, such as smoking, obesity, hypertension, lipid metabolism disorder, and hyperglycemia. For patients with chronic diseases, lifestyle intervention and health education should be carried out to improve the diagnosis rate and control rate. The project focuses on the impact of lifestyle interventions and health education on risk factor control, cardiovascular and cerebrovascular complications, diabetes and all-cause death.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Internet Technology Based Life-style and Care Intervention for Risk Factors of Non Communicable Diseases（NCD）-a Randomized, Controlled Trial in Communities Following up for 50 Years
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2070
Estimated Study Completion Date : December 1, 2070
Arms and Interventions
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Arm Intervention/treatment
Intensive intervention group
intensive life-style and care intervention
 Behavioral: Intensive intervention group
Establish a team of chronic disease prevention managers (5 people), with each educator responsible for the intervention of 200 people. For sub-health population and chronic disease patients, there would be conducted health education interview twice, 4 calls, online communication 50 times once a year, controlling risk factors and making treatment plan.
Standard intervention group
standard life-style and care intervention
 Behavioral: standard intervention group
Conduct general health education without active management


Outcome Measures
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Primary Outcome Measures :
  1. incidence rate of new noncommunicable diseases [ Time Frame: 2 year ]
    incidence rate of new noncommunicable diseases, for example, ASCVD, diabetes mellitus, hypertension

  2. incidence rate of major adverse cardiovascular events [ Time Frame: 2 years ]
    incidence rate of major adverse cardiovascular events, including nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death

  3. incidence rate of all-cause mortality [ Time Frame: 2 years ]
    incidence rate of all-cause mortality in the population


Secondary Outcome Measures :
  1. score of quality of life (SF-36 scale) [ Time Frame: 2 years ]
    the improvement of quality of life

  2. Reduce the economic burden on health [ Time Frame: 2 years ]
    survey of health economic burden, calculate medical expenses


Eligibility Criteria
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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women older than 25 years of age with two or more risk factors as follows, BMI≥24 or BMI≤18.5 kg/m2, smoking, active exercise less than 30 minutes every day, blood pressure higher than 130/85 mmHg, dyslipidemia, fasting glucose higher than 6.1mmol/l, fatty liver.
  • Patients with hypertension, diabetes and ASCVD

Exclusion Criteria:

  • Patients had not signed the consent form
  • Patients with severe heart failure, hepatic failure, renal failure and malignant tumor.
  • Patients planing pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04567121


Contacts
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Contact: jianzhong xiao, PHD +8613683685711 xiaojzh858@sina.com

Locations
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China, Beijing
Beijing Tsinghua Changgung Hospital Recruiting
Beijing, Beijing, China, Beijing, BJ 10
Contact: zhaoxiang liu, MD    +8613718898419    lzxa01684@btch.edu.cn   
Sponsors and Collaborators
Beijing Tsinghua Chang Gung Hospital
Investigators
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Study Director: jianzhong xiao, PHD Beijing Tsinghua Changgeng Hospital
More Information
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Responsible Party: Beijing Tsinghua Chang Gung Hospital
ClinicalTrials.gov Identifier: NCT04567121    
Other Study ID Numbers: 20281-0-01
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing Tsinghua Chang Gung Hospital:
Internet Technology
lifestyle intervention
Non Communicable Diseases
Additional relevant MeSH terms:
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Noncommunicable Diseases
Disease Attributes
Pathologic Processes