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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

Tracking Information
First Submitted Date  ICMJE September 7, 2020
First Posted Date  ICMJE September 28, 2020
Last Update Posted Date September 28, 2020
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date January 1, 2070   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2020)
  • incidence rate of new noncommunicable diseases [ Time Frame: 2 year ]
    incidence rate of new noncommunicable diseases, for example, ASCVD, diabetes mellitus, hypertension
  • 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
  • incidence rate of all-cause mortality [ Time Frame: 2 years ]
    incidence rate of all-cause mortality in the population
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2020)
  • score of quality of life (SF-36 scale) [ Time Frame: 2 years ]
    the improvement of quality of life
  • Reduce the economic burden on health [ Time Frame: 2 years ]
    survey of health economic burden, calculate medical expenses
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Internet Technology Based Life-style and Care Intervention for Risk Factors of Non Communicable Diseases(NCD)
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Lifestyle Intervention
  • Non Communicable Diseases
Intervention  ICMJE
  • 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.
  • Behavioral: standard intervention group
    Conduct general health education without active management
Study Arms  ICMJE
  • Intensive intervention group
    intensive life-style and care intervention
    Intervention: Behavioral: Intensive intervention group
  • Standard intervention group
    standard life-style and care intervention
    Intervention: Behavioral: standard intervention group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 22, 2020)
60000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2070
Estimated Primary Completion Date January 1, 2070   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: jianzhong xiao, PHD +8613683685711 xiaojzh858@sina.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04567121
Other Study ID Numbers  ICMJE 20281-0-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Beijing Tsinghua Chang Gung Hospital
Study Sponsor  ICMJE Beijing Tsinghua Chang Gung Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: jianzhong xiao, PHD Beijing Tsinghua Changgung Hospital
PRS Account Beijing Tsinghua Chang Gung Hospital
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP