Hypertension and Diabetes Mellitus Community Management C... | NCT04229628

Studies
Hypertension and Diabetes Mellitus Community Management Center(HAD-COME) Project

NCT04229628

Sponsor

Guangdong Provincial People's Hospital

Status

Unknown status

Last Update Posted

Jan 18, 2020Actual

Enrollment

100,000Estimated

Phase

Not provided

Conditions

Hypertension
Diabetes Mellitus

Interventions

No special intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Jan 12, 2020

First Submission Date that Met QC Criteria

Jan 12, 2020

First Posted Date

Jan 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2020

Last Update Posted Date

Jan 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To develop and implement quality improvement programs for the treatment and management of hypertension and diabetes,and preventing and controlling hypertension and diabetes-related diseases in Chinese community. This program will use data collection, analysis, feedback, and process improvement to extend the use of evidence-based guidelines throughout the healthcare system and improve patient care of hypertension and diabetes in Chinese community.

Detailed Description

The aim of this project was to improving care for hypertension and diabetes mellitus in Chinese community. Study population including subjects who are hypertension and/or diabetes mellitus, of any race or ethnicity, any age.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
No special intervention	Other	No special intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of community hypertension patients receiving treatment as Chinese guideline recommended	Proportion of community hypertension patients receiving treatment as Chinese guideline recommended at the time of enrollment	at the time of enrollment
Proportion of community diabetes mellitus patients receiving treatment as Chinese guideline recommended	Proportion of community diabetes mellitus patients receiving treatment as Chinese guideline recommended at the time of enrollment	at the time of enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

In accordance with the diagnosis of essential hypertension;
In accordance with the diagnosis of type 2 diabetes mellitus.

Exclusion Criteria:

Non-type 2 diabetes patients
Secondary hypertension
Non-hypertensive patients
Type 1 diabetes or other types of diabetes

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Hypertension Diabetes mellitus

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Feng Ying-qing, PhD	Contact	+862083827812		651792209@qq.com

Overall Officials

Name	Affiliation	Role
Feng Ying-qing, PhD	Guangdong Provincial People's Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guangdong Provincial People's Hospital	Recruiting	Guangzhou	Guangdong	510080	China

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided