Cardiovascular DiseasesKEHSNCT05141565
The Kunshan Elderly Health Study
An observational study of Cardiovascular Diseases and Diabetes Mellitus, run by Soochow University at 1 site in China.
Trial summary
The Kunshan Elderly Health Study (KEHS) is a community-based prospective cohort study of chronic disease, mortality and associated factors among elderly adults in Kunshan, Eastern China. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cardiovascular Diseases, Diabetes Mellitus, Cancer
- How many people
- 5,945 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2021to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Approximately 8,000 elderly residents (both men and women) aged 65 years and above in communities in Kunshan, Eastern China.
Who may be able to join
- Locally registered-residents in Kunshan
- Aged 65 years or above
- Voluntary agreement to participate in the study (with written informed consent)
Who cannot join
- Patients with stroke, coronary heart disease or cancer
- Patients with severe physical or mental illness
- People unable to complete the survey
Trial locations and contacts
1 site in 1 country.
China1 site
Kunshan Center for Disease Control and Prevention
Kunshan, Jiangsu, 215301
About this study
Official title: The Kunshan Elderly Health Study - a Community-based Prospective Cohort Study of Chronic Disease, Mortality and Associated Factors Among Elderly Chinese
The Kunshan Elderly Health Study (KEHS) is a community-based prospective cohort study of chronic disease, mortality and associated factors among elderly adults in Kunshan, Eastern China.
Read the detailed description
The Kunshan Elderly Health Study (KEHS) is a project organized by the Soochow University, in collaboration with the Kunshan \& Suzhou Centers for Disease Control and Prevention. It was primarily designed to assess risk factors (nutritional, metabolic, lifestyle, etc.) for chronic diseases and mortality among community residents aged 65 years and above, and explore effective intervention measures, so as to ultimately reduce the burden of disease and promote healthy aging. In addition, findings of this study would contribute to further understanding of pathogenesis of the chronic diseases and provide new ideas for precise prevention, drug development and risk prediction.
- Conditions
- Cardiovascular Diseases, Diabetes Mellitus, Cancer, Cognitive Impairment, Sarcopenia, Frailty
- Being tested
- No intervention
- Keywords
- Nutrition, Lifestyle, Cohort, Elderly
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Neoplasms, Cognitive Dysfunction, Sarcopenia, Frailty, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| The Kunshan Elderly Health Study (KEHS) | Community-based observational cohort. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of chronic diseases
Chronic diseases including cardiovascular disease, diabetes, cancer, etc. will be identified by chronic disease registries and active follow-up
Measured: Trough study completion, an average of 10 years
Mortality
Total and cause-specific mortality
Measured: Trough study completion, an average of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start17 May 2021
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,945 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soochow University
- Sponsor type
- University, hospital or other
- Collaborators
- Kunshan Center for Disease Control and Prevention, Suzhou Center for Disease Control and Prevention
- Responsible party
- Principal investigator, Hui Zuo, Soochow University
- Investigators
- Hui Zuo, M.D., Ph.D., Principal investigator, Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141565
- Sponsor's protocol ID
- SUDA20210122H03
- Acronym
- KEHS
- Status last verified
- Apr 2024
- First submitted
- 15 Nov 2021
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Limited information may be shared with other researchers on request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Kunshan Elderly Health Study - a Community-based Prospective Cohort Study of Chronic Disease, Mortality and Associated Factors Among Elderly Chinese
- ClinicalTrials.gov ID
- NCT05141565
- Acronym / sponsor ID
- KEHS / SUDA20210122H03
- Conditions
- Cardiovascular Diseases, Diabetes Mellitus, Cancer, Cognitive Impairment, Sarcopenia, Frailty
- Keywords
- Nutrition, Lifestyle, Cohort, Elderly
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,945 participants (actual)
- Lead sponsor
- Soochow UniversityUniversity, hospital or other
- Collaborators
- Kunshan Center for Disease Control and Prevention, Suzhou Center for Disease Control and Prevention
- Study start
- 17 May 2021 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 2 Dec 2021 (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.
The Kunshan Elderly Health Study (KEHS) is a community-based prospective cohort study of chronic disease, mortality and associated factors among elderly adults in Kunshan, Eastern China.
Detailed description
The Kunshan Elderly Health Study (KEHS) is a project organized by the Soochow University, in collaboration with the Kunshan \& Suzhou Centers for Disease Control and Prevention. It was primarily designed to assess risk factors (nutritional, metabolic, lifestyle, etc.) for chronic diseases and mortality among community residents aged 65 years and above, and explore effective intervention measures, so as to ultimately reduce the burden of disease and promote healthy aging. In addition, findings of this study would contribute to further understanding of pathogenesis of the chronic diseases and provide new ideas for precise prevention, drug development and risk prediction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Kunshan Elderly Health Study (KEHS) | – | Other: No interventionCommunity-based observational cohort. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Approximately 8,000 elderly residents (both men and women) aged 65 years and above in communities in Kunshan, Eastern China.
Key inclusion criteria (3 listed)
- Locally registered-residents in Kunshan
- Aged 65 years or above
- Voluntary agreement to participate in the study (with written informed consent)
Key exclusion criteria (3 listed)
- Patients with stroke, coronary heart disease or cancer
- Patients with severe physical or mental illness
- People unable to complete the survey
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 interventionNo intervention | Other | The Kunshan Elderly Health Study (KEHS) |
Primary outcome
Incidence of chronic diseases
Time frame: Trough study completion, an average of 10 years
Chronic diseases including cardiovascular disease, diabetes, cancer, etc. will be identified by chronic disease registries and active follow-up
Mortality
Time frame: Trough study completion, an average of 10 years
Total and cause-specific mortality
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: Undecided. Limited information may be shared with other researchers on request.
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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.
Hui Zuo, M.D., Ph.D. principal investigator
Soochow University
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 Cardiovascular Diseases and Diabetes Mellitus, run by Soochow University 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of chronic diseases (time frame: Trough study completion, an average of 10 years). 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 22 Apr 2024.