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Early-warning Intervention for Heat Waves and Cold Spells in Older Hypertensive Patients

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Information notification based on the health warning system for heat waves and cold spells
The electrocardiography(ECG) and blood pressure monitoring
Sponsored by
Tiantian Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension

Eligibility Criteria

60 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 60 ≤ 65 years old Volunteer to participate in this study Exclusion Criteria: Patients with a history of coronary heart disease, heart failure, stroke or diabetes were exclueded. Unable to cooperate with follow-up

Sites / Locations

  • National Institute of Environmental Health, Chinese Center for Disease Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

No Intervention

Arm Label

Early-warning interventions

Health monitoring

Blank control

Arm Description

The elderly in the intervention group will receive warning messages through WeChat mini programs and monitor daily exposure temperature, electrocardiogram (ECG), and blood pressure indicators

The exposure temperature, electrocardiography (ECG), and blood pressure indicators will be monitored every day during the study period in the monitoring group

The blank control group will only monitor the exposure temperature every day.

Outcomes

Primary Outcome Measures

Observation indicators:Individual fundamental information
Weight and height will be combined to report BMI in kilogram/meter^2 (kg/m^2).
Observation indicators:Sleep quality
Sleep duration in hour.
Functional indicators:Blood pressure
Diastolic pressure and systolic pressure in millimetre of mercury (mmHg).
Functional indicators:Monitoring indicators of electrocardiogram-1
AverageHeartRate in beat per minute(bpm),MaxHeartRate in bpm,MinHeartRate in bpm.
Functional indicators:Monitoring indicators of electrocardiogram-2
ECG QT interval inMillisecond(ms),PR interval in ms.
Functional indicators:Monitoring indicators of electrocardiogram-3
QRS Electrical axis in degree.

Secondary Outcome Measures

Experimental test index:Biomarkers of inflammation in the cardiovascular system-1
Cardiac troponin in microgram/litre(μg/L),Heart fatty acid binding protein in μg/L.
Experimental test index:Biomarkers of inflammation in the cardiovascular system-2
C-reactiveprotein in milligram/litre(mg/L),D-dimer in mg/L.
Experimental test index:Biomarkers of inflammation in the cardiovascular system-3
Creatine kinase isoenzyme-MB in unit/liter(U/L).
Experimental test index:Biomarkers of inflammation in the cardiovascular system-4
NT-proBNP in picogram/milliLiter(pg/ml),Interleukin-6 in pg/ml.
Experimental test index:Biomarkers of inflammation in the cardiovascular system-5
Myoglobin in nanogram/milliliter(ng/mL).
Experimental test index:Biomarkers of inflammation in the cardiovascular system-6
B-type natriuretic peptides in picogram/Litre(pg/L).

Full Information

First Posted
June 4, 2023
Last Updated
August 28, 2023
Sponsor
Tiantian Li
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1. Study Identification

Unique Protocol Identification Number
NCT06011213
Brief Title
Early-warning Intervention for Heat Waves and Cold Spells in Older Hypertensive Patients
Official Title
A Health-risk Early-warning Intervention for Heat Waves and Cold Spells in Older Hypertensive Patients in Tianjin, China: an Open, Cluster-randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tiantian Li

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study was designed to explore the impact of health-risk early-warning interventions for heat waves and cold spells on older hypertensive patients.
Detailed Description
From June 15th 2023 to August 31st 2023, and December 1st 2023 to February 28th 2024, researchers will conduct a double-blind, cluster randomised controlled trial involving 258 hypertensive patients aged 60 to 65 years in Wuqing District, Tianjin. For the sampling stage, three communities will be randomly selected in Wuqing District. The geographical distribution, urbanisation, population size, population structure, economic status, and health service resources of each selected community are in equilibrium. Meanwhile, the distance between the selected communities is greater than 5 km. Based on the list of chronic disease management records, 86 older hypertensive patients (male: female = 1:1) in each community will be involved in the intervention group, monitoring group, and blank control group, respectively. Eligible individuals for this trial will be a mean untreated systolic blood pressure of at least 140 mmHg or a mean untreated diastolic blood pressure of at least 90 mmHg, or a mean treated systolic blood pressure of at least 130 mmHg or a mean treated diastolic blood pressure of at least 80 mmHg. Patients with a history of coronary heart disease, heart failure, stroke or diabetes were exclueded. For the intervention stage, different groups have different intervention modalities including heat waves or cold spells warnings, monitoring of health indicators, questionnaire surveys, health checkups and biological sample collection. According to the heat waves or cold spells health warning systems conducted by National Institute of Environmental Health in the Chinese Center for Disease Control and Prevention, whenever a health risk warning for a heat waves or cold spells is issued, only the elderly in the intervention group will be alerted to the early warning information through the Wechat Mini Programme. The exposure temperature, electrocardiography (ECG), and blood pressure indicators will be monitored every day during the study period in the intervention group and monitoring group, respectively. The blank control group will only monitor the exposure temperature every day. Besides, the study period will be divided into two parts including pre-intervention and intervention periods, respectively, and all the patients will have questionnaire surveys, health checkups and biological sample collections once in the pre-intervention period and three times in the intervention period. Biological biomarkers of inflammation and oxidative stress in the cardiovascular system will be tested. The content of the questionnaire will include individual fundamental information, the perception of the health risk of heat waves and cold spells, sleep quality, hypertension medication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
258 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early-warning interventions
Arm Type
Experimental
Arm Description
The elderly in the intervention group will receive warning messages through WeChat mini programs and monitor daily exposure temperature, electrocardiogram (ECG), and blood pressure indicators
Arm Title
Health monitoring
Arm Type
Other
Arm Description
The exposure temperature, electrocardiography (ECG), and blood pressure indicators will be monitored every day during the study period in the monitoring group
Arm Title
Blank control
Arm Type
No Intervention
Arm Description
The blank control group will only monitor the exposure temperature every day.
Intervention Type
Behavioral
Intervention Name(s)
Information notification based on the health warning system for heat waves and cold spells
Intervention Description
Whenever a health risk warning for a heat waves or cold spells is issued, only the elderly in the intervention group will be alerted to the early warning information through the Wechat Mini Programme.
Intervention Type
Device
Intervention Name(s)
The electrocardiography(ECG) and blood pressure monitoring
Intervention Description
The electrocardiography (ECG) and blood pressure indicators will be monitored every day during the study period in the intervention group and monitoring group, respectively.
Primary Outcome Measure Information:
Title
Observation indicators:Individual fundamental information
Description
Weight and height will be combined to report BMI in kilogram/meter^2 (kg/m^2).
Time Frame
six months
Title
Observation indicators:Sleep quality
Description
Sleep duration in hour.
Time Frame
six months
Title
Functional indicators:Blood pressure
Description
Diastolic pressure and systolic pressure in millimetre of mercury (mmHg).
Time Frame
six months
Title
Functional indicators:Monitoring indicators of electrocardiogram-1
Description
AverageHeartRate in beat per minute(bpm),MaxHeartRate in bpm,MinHeartRate in bpm.
Time Frame
six months
Title
Functional indicators:Monitoring indicators of electrocardiogram-2
Description
ECG QT interval inMillisecond(ms),PR interval in ms.
Time Frame
six months
Title
Functional indicators:Monitoring indicators of electrocardiogram-3
Description
QRS Electrical axis in degree.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Experimental test index:Biomarkers of inflammation in the cardiovascular system-1
Description
Cardiac troponin in microgram/litre(μg/L),Heart fatty acid binding protein in μg/L.
Time Frame
six months
Title
Experimental test index:Biomarkers of inflammation in the cardiovascular system-2
Description
C-reactiveprotein in milligram/litre(mg/L),D-dimer in mg/L.
Time Frame
six months
Title
Experimental test index:Biomarkers of inflammation in the cardiovascular system-3
Description
Creatine kinase isoenzyme-MB in unit/liter(U/L).
Time Frame
six months
Title
Experimental test index:Biomarkers of inflammation in the cardiovascular system-4
Description
NT-proBNP in picogram/milliLiter(pg/ml),Interleukin-6 in pg/ml.
Time Frame
six months
Title
Experimental test index:Biomarkers of inflammation in the cardiovascular system-5
Description
Myoglobin in nanogram/milliliter(ng/mL).
Time Frame
six months
Title
Experimental test index:Biomarkers of inflammation in the cardiovascular system-6
Description
B-type natriuretic peptides in picogram/Litre(pg/L).
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 60 ≤ 65 years old Volunteer to participate in this study Exclusion Criteria: Patients with a history of coronary heart disease, heart failure, stroke or diabetes were exclueded. Unable to cooperate with follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiantian Li
Phone
010-50930213
Email
litiantian@nieh.chinacdc.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiantian Li
Organizational Affiliation
National lnstitute of Environmental Health, Chinese Center for Disease Controland Prevention
Official's Role
Study Director
Facility Information:
Facility Name
National Institute of Environmental Health, Chinese Center for Disease Control and Prevention
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
tiantian Li
Phone
010-50930213
Email
litiantian@nieh.chinacdc.cn

12. IPD Sharing Statement

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Early-warning Intervention for Heat Waves and Cold Spells in Older Hypertensive Patients

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