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

Sponsor
Beijing Tsinghua Chang Gung Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04567121
Collaborator
(none)
60,000
1
2
635
94.5

Study Details

Study Description

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
  • Behavioral: Intensive intervention group
  • Behavioral: standard intervention group
N/A

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

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2018
Anticipated Primary Completion Date :
Jan 1, 2070
Anticipated Study Completion Date :
Dec 1, 2070

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Other: Standard intervention group

standard life-style and care intervention

Behavioral: standard intervention group
Conduct general health education without active management

Outcome Measures

Primary Outcome Measures

  1. incidence rate of new noncommunicable diseases [2 year]

    incidence rate of new noncommunicable diseases, for example, ASCVD, diabetes mellitus, hypertension

  2. incidence rate of major adverse cardiovascular events [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 [2 years]

    incidence rate of all-cause mortality in the population

Secondary Outcome Measures

  1. score of quality of life (SF-36 scale) [2 years]

    the improvement of quality of life

  2. Reduce the economic burden on health [2 years]

    survey of health economic burden, calculate medical expenses

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Beijing Tsinghua Changgung Hospital Beijing Beijing China Beijing, BJ 10

Sponsors and Collaborators

  • Beijing Tsinghua Chang Gung Hospital

Investigators

  • Study Director: jianzhong xiao, PHD, Beijing Tsinghua Changgeng Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beijing Tsinghua Chang Gung Hospital
ClinicalTrials.gov Identifier:
NCT04567121
Other Study ID Numbers:
  • 20281-0-01
First Posted:
Sep 28, 2020
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 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 Beijing Tsinghua Chang Gung Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022