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

Blood Pressure Clinical Trial

Official title:

Home Blood Pressure Registration Study on Community Elderly Population(HOME Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04212468
• Other study ID #: 2018300H(R1)
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2050

Study information

• Verified date: December 2019
• Source: Guangdong Provincial People's Hospital
• Contact: Feng Ying-qing, PhD
• Phone: +862083827812
• Email: 651792209[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 31, 2050
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

•=65 years old

• Signed informed consent

• Life expectancy is greater than 1 year

Exclusion Criteria:

• <65 years old

• Unsigned informed consent

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
China	Feng Yingqing	Guangzhou	Guangdong
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with reported hospitalization due to other diseases	The incidence rate of tumor, fracture, cataract etc.	From date of inclusion until the date of first event, assessed up to 1 year
Primary	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.	From date of inclusion until the date of death from any cause, assessed up to 1 year
Primary	Cardiovascular Mortality	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	Secondary outcomes of cardiovascular diseases	The number of and the incidence rate of cardiovascular diseases.	Through study completion, an average of 1 years
Secondary	Secondary outcomes of cerebrovascular diseases	The incidence rate of cerebrovascular diseases.	Through study completion, an average of 1 years
Secondary	Secondary outcomes of kidney	The incidence rate of renal injure and end-stage renal disease	Through study completion, an average of 1 years
Secondary	Secondary outcomes of hypertension	The incidence rate of hypertension	Through study completion, an average of 1 years
Secondary	Secondary outcomes of diabetes	The incidence rate of diabetes	Through study completion, an average of 1 years