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

August 28, 2023 updated by: Tiantian Li

A Health-risk Early-warning Intervention for Heat Waves and Cold Spells in Older Hypertensive Patients in Tianjin, China: an Open, Cluster-randomised Trial

This study was designed to explore the impact of health-risk early-warning interventions for heat waves and cold spells on older hypertensive patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

258

Phase

  • Not Applicable

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
      • Beijing, China, 100021
        • Recruiting
        • National Institute of Environmental Health, Chinese Center for Disease Control and Prevention
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early-warning interventions
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
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.
Other: Health monitoring
The exposure temperature, electrocardiography (ECG), and blood pressure indicators will be monitored every day during the study period in the monitoring group
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.
No Intervention: Blank control
The blank control group will only monitor the exposure temperature every day.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Tiantian Li

Investigators

  • Study Director: Tiantian Li, National lnstitute of Environmental Health, Chinese Center for Disease Controland Prevention

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)

June 15, 2023

Primary Completion (Estimated)

February 28, 2024

Study Completion (Estimated)

February 28, 2024

Study Registration Dates

First Submitted

June 4, 2023

First Submitted That Met QC Criteria

August 21, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202361

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.

Clinical Trials on Hypertension

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe