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

Recruiting

• Conditions: Blood Pressure

• Registration Number: NCT04212468
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief 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. 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 Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-24
• Study First Submitted QC: 2019-12-24
• Study First Posted: 2019-12-27
• Study Start: 2020-01-01
• Last Update Submitted: 2020-01-10
• Last Update Posted: 2020-01-13
• Primary Completion: 2024-12-31
• Study Completion: 2050-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

•≥65 years old

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

Exclusion Criteria

• <65 years old
• Unsigned informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-Cause Mortality	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	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).

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Feng Yingqing; 🇨🇳 Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China