Blood PressureNCT04212468
Home Blood Pressure Monitoring Registration Study in the Elderly(HOME Study)
An observational study of Blood Pressure, run by Guangdong Provincial People's Hospital at 2 sites in China.
Trial summary
China is entering an aging society. As the number of elderly population continues to increase, the elderly are facing many social problems that deserve the attention of all sectors of society. Hypertension is one of the common diseases in the elderly population. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- How many people
- 6,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2020to 31 Dec 2050
- How long will I take part?
- 30 Years
- 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
- Healthy volunteers accepted
- Older adult
Study population: Study population includes subjects who living in community, of any race or ethnicity, 65 or older years of age.
Who may be able to join
- •≥65 years old
- Signed informed consent
- Life expectancy is greater than 1 year
Who cannot join
- <65 years old
- Unsigned informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Feng Yingqing
Guangzhou, Guangdong, 510080
Feng Ying-qing, PhD, +862083827812, 651792209@qq.com
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
FENG Ying-qing, 02083827812, fyq1819@163.com
About this study
Official title: Home Blood Pressure Registration Study on Community Elderly Population(HOME Study)
China is entering an aging society. As the number of elderly population continues to increase, the elderly are facing many social problems that deserve the attention of all sectors of society. Hypertension is one of the common diseases in the elderly population. Hypertension is the most common chronic diseases and a most important risk factor for cardiovascular and cerebrovascular diseases, and also a substantial public health problem. Home blood pressure monitoring is simple, not only can find hypertension, but also can guide the treatment of patients with hypertension. The purpose of the study is to investigate the association between home blood pressure and adverse outcomes in community elderly population.
Read the detailed description
Study population includes subjects who living in community, of any race or ethnicity, 65 or older years of age, and have provided written informed consent to provide home blood pressure monitoring at one or more study visits.
Physical examination, questionnaire survey and biological sample collection will be conducted at baseline and the incidence of a composite of major adverse cardiovascular events will be investigated during follow-up.
- Conditions
- Blood Pressure
- Being tested
- no intervention
- Keywords
- Blood Pressure, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality
All-cause mortality was confirmed through a combination of hospital medical records, telephone contacts with patients or family members, and death registration at the Center for Disease Control and Prevention.
Measured: From date of inclusion until the date of death from any cause, assessed up to 1 year
Cardiovascular Mortality
Cardiovascular mortality was defined as death attributable to an ischemic cardiovascular cause (including fatal cardiovascular events and stroke).
Measured: From date of inclusion until the date of death from any cause, assessed up to 1 year
Secondary outcomes (5)
Secondary outcomes of cardiovascular diseases
The number of and the incidence rate of cardiovascular diseases.
Measured: Through study completion, an average of 1 years
Secondary outcomes of cerebrovascular diseases
The incidence rate of cerebrovascular diseases.
Measured: Through study completion, an average of 1 years
Secondary outcomes of kidney
The incidence rate of renal injure and end-stage renal disease
Measured: Through study completion, an average of 1 years
Secondary outcomes of hypertension
The incidence rate of hypertension
Measured: Through study completion, an average of 1 years
Secondary outcomes of diabetes
The incidence rate of diabetes
Measured: Through study completion, an average of 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2019
- Study start1 Jan 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
- Target duration
- 30 Years
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 chair, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212468
- Sponsor's protocol ID
- 2018300H(R1)
- Status last verified
- Dec 2019
- First submitted
- 24 Dec 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Blood Pressure Registration Study on Community Elderly Population(HOME Study)
- ClinicalTrials.gov ID
- NCT04212468
- Acronym / sponsor ID
- 2018300H(R1)
- Conditions
- Blood Pressure
- Keywords
- Blood Pressure, Elderly
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 27 Dec 2019 (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.
China is entering an aging society. As the number of elderly population continues to increase, the elderly are facing many social problems that deserve the attention of all sectors of society. Hypertension is one of the common diseases in the elderly population. Hypertension is the most common chronic diseases and a most important risk factor for cardiovascular and cerebrovascular diseases, and also a substantial public health problem. Home blood pressure monitoring is simple, not only can find hypertension, but also can guide the treatment of patients with hypertension. The purpose of the study is to investigate the association between home blood pressure and adverse outcomes in community elderly population.
Detailed description
Study population includes subjects who living in community, of any race or ethnicity, 65 or older years of age, and have provided written informed consent to provide home blood pressure monitoring at one or more study visits.
Physical examination, questionnaire survey and biological sample collection will be conducted at baseline and the incidence of a composite of major adverse cardiovascular events will be investigated during follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Years
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Study population includes subjects who living in community, of any race or ethnicity, 65 or older years of age.
Key inclusion criteria (3 listed)
- •≥65 years old
- Signed informed consent
- Life expectancy is greater than 1 year
Key exclusion criteria (2 listed)
- <65 years old
- Unsigned informed consent
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 | – |
Primary outcome
All-Cause Mortality
Time frame: From date of inclusion until the date of death from any cause, assessed up to 1 year
All-cause mortality was confirmed through a combination of hospital medical records, telephone contacts with patients or family members, and death registration at the Center for Disease Control and Prevention.
Cardiovascular Mortality
Time frame: From date of inclusion until the date of death from any cause, assessed up to 1 year
Cardiovascular mortality was defined as death attributable to an ischemic cardiovascular cause (including fatal cardiovascular events and stroke).
5 secondary outcomes
Secondary outcomes of cardiovascular diseases
Time frame: Through study completion, an average of 1 years
Secondary outcomes of cerebrovascular diseases
Time frame: Through study completion, an average of 1 years
Secondary outcomes of kidney
Time frame: Through study completion, an average of 1 years
Secondary outcomes of hypertension
Time frame: Through study completion, an average of 1 years
Secondary outcomes of diabetes
Time frame: Through study completion, an average of 1 years
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 13 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Feng Ying-qing, PhD study chair
Guangdong Provincial People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by Guangdong Provincial People's Hospital at 2 sites 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 2 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: looking for participants now, as of the sponsor's last update on 13 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 2 sites 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?
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?
All-Cause Mortality (time frame: From date of inclusion until the date of death from any cause, assessed up to 1 year). 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 13 Jan 2020.