Home Blood Pressure Monitoring Registration Study in the Elderly(HOME Study)

January 10, 2020 updated by: Guangdong Provincial People's Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
      • Guangzhou, Guangdong, China, 510080
        • Not yet recruiting
        • Feng Yingqing
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study population includes subjects who living in community, of any race or ethnicity, 65 or older years of age.

Description

Inclusion Criteria:

•≥65 years old

  • Signed informed consent
  • Life expectancy is greater than 1 year

Exclusion Criteria:

  • <65 years old
  • Unsigned informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of inclusion until the date of death from any cause, assessed up to 1 year
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).
From date of inclusion until the date of death from any cause, assessed up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary outcomes of cardiovascular diseases
Time Frame: Through study completion, an average of 1 years
The number of and the incidence rate of cardiovascular diseases.
Through study completion, an average of 1 years
Secondary outcomes of cerebrovascular diseases
Time Frame: Through study completion, an average of 1 years
The incidence rate of cerebrovascular diseases.
Through study completion, an average of 1 years
Secondary outcomes of kidney
Time Frame: Through study completion, an average of 1 years
The incidence rate of renal injure and end-stage renal disease
Through study completion, an average of 1 years
Secondary outcomes of hypertension
Time Frame: Through study completion, an average of 1 years
The incidence rate of hypertension
Through study completion, an average of 1 years
Secondary outcomes of diabetes
Time Frame: Through study completion, an average of 1 years
The incidence rate of diabetes
Through study completion, an average of 1 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with reported hospitalization due to other diseases
Time Frame: From date of inclusion until the date of first event, assessed up to 1 year
The incidence rate of tumor, fracture, cataract etc.
From date of inclusion until the date of first event, assessed up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Investigators

  • Study Chair: Feng Ying-qing, PhD, Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2050

Study Registration Dates

First Submitted

December 24, 2019

First Submitted That Met QC Criteria

December 24, 2019

First Posted (Actual)

December 27, 2019

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 10, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018300H(R1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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