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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06011213
• Other study ID #: 202361
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: August 2023
• Source: Centers for Disease Control and Prevention, China
• Contact: Tiantian Li
• Phone: 010-50930213
• Email: litiantian[@]nieh.chinacdc.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 258
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Information notification based on the health warning system for heat waves and cold spells
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.

Device:
• The electrocardiography(ECG) and blood pressure monitoring
The electrocardiography (ECG) and blood pressure indicators will be monitored every day during the study period in the intervention group and monitoring group, respectively.

Locations

Country	Name	City	State
China	National Institute of Environmental Health, Chinese Center for Disease Control and Prevention	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Tiantian Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observation indicators:Individual fundamental information	Weight and height will be combined to report BMI in kilogram/meter^2 (kg/m^2).	six months
Primary	Observation indicators:Sleep quality	Sleep duration in hour.	six months
Primary	Functional indicators:Blood pressure	Diastolic pressure and systolic pressure in millimetre of mercury (mmHg).	six months
Primary	Functional indicators:Monitoring indicators of electrocardiogram-1	AverageHeartRate in beat per minute(bpm),MaxHeartRate in bpm,MinHeartRate in bpm.	six months
Primary	Functional indicators:Monitoring indicators of electrocardiogram-2	ECG QT interval inMillisecond(ms),PR interval in ms.	six months
Primary	Functional indicators:Monitoring indicators of electrocardiogram-3	QRS Electrical axis in degree.	six months
Secondary	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.	six months
Secondary	Experimental test index:Biomarkers of inflammation in the cardiovascular system-2	C-reactiveprotein in milligram/litre(mg/L),D-dimer in mg/L.	six months
Secondary	Experimental test index:Biomarkers of inflammation in the cardiovascular system-3	Creatine kinase isoenzyme-MB in unit/liter(U/L).	six months
Secondary	Experimental test index:Biomarkers of inflammation in the cardiovascular system-4	NT-proBNP in picogram/milliLiter(pg/ml),Interleukin-6 in pg/ml.	six months
Secondary	Experimental test index:Biomarkers of inflammation in the cardiovascular system-5	Myoglobin in nanogram/milliliter(ng/mL).	six months
Secondary	Experimental test index:Biomarkers of inflammation in the cardiovascular system-6	B-type natriuretic peptides in picogram/Litre(pg/L).	six months