HypertensionNCT04229628
Hypertension and Diabetes Mellitus Community Management Center(HAD-COME) Project
An observational study of Hypertension and Diabetes Mellitus, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension, Diabetes Mellitus
- What is being tested?
- No special intervention
- How many people
- 100,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Hypertension Diabetes mellitus
Who may be able to join
- In accordance with the diagnosis of essential hypertension;
- In accordance with the diagnosis of type 2 diabetes mellitus.
Who cannot join
- Non-type 2 diabetes patients
- Secondary hypertension
- Non-hypertensive patients
- Type 1 diabetes or other types of diabetes
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
FENG Yi ng-qing, PhD, +862083827812, 651792209@qq.com
About this study
Official title: Establishment of Hypertension and Diabetes Mellitus Community Management Center(HAD-COME) Project
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.
Read the 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.
- Conditions
- Hypertension, Diabetes Mellitus
- Being tested
- No special intervention
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No special interventionOther
No special intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: at the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng Ying-qing, PhD, Study director, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229628
- Sponsor's protocol ID
- 2019364H(R1)
- Status last verified
- Dec 2019
- First submitted
- 12 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Hypertension and Diabetes Mellitus Community Management Center(HAD-COME) Project
- ClinicalTrials.gov ID
- NCT04229628
- Acronym / sponsor ID
- 2019364H(R1)
- Conditions
- Hypertension, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Hypertension Diabetes mellitus
Key inclusion criteria (2 listed)
- In accordance with the diagnosis of essential hypertension;
- In accordance with the diagnosis of type 2 diabetes mellitus.
Key exclusion criteria (4 listed)
- Non-type 2 diabetes patients
- Secondary hypertension
- Non-hypertensive patients
- Type 1 diabetes or other types of diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No special interventionNo special intervention | Other | – |
Primary outcome
Proportion of community hypertension patients receiving treatment as Chinese guideline recommended
Time frame: at the time of enrollment
Proportion of community hypertension patients receiving treatment as Chinese guideline recommended at the time of enrollment
Proportion of community diabetes mellitus patients receiving treatment as Chinese guideline recommended
Time frame: at the time of enrollment
Proportion of community diabetes mellitus patients receiving treatment as Chinese guideline recommended at the time of enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng Ying-qing, PhD study director
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Diabetes Mellitus, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Ying-qing, PhD (+862083827812, 651792209@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of community hypertension patients receiving treatment as Chinese guideline recommended (time frame: at the time of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.