Early-warning Intervention for Heat and Cold in Older Hypertensive Patients: Impact on Blood Pressure and ECG

Early-warning Intervention for Heat and Cold in Older Hypertensive Patients: Impact on Blood Pressure and Electrocardiogram

This cluster-randomized trial, conducted in Tianjin, China, aims to evaluate the effectiveness of integrating a digital health risk early warning tool for heat with self-monitoring. Additionally, the study assesses the effectiveness of combining a digital health risk early warning tool for cold with self-monitoring. Communities from three districts will be randomly assigned to one of three groups: the combined intervention group (receiving health warnings via a WeChat mini-program and self-monitoring), the self-monitoring group (daily blood pressure (BP) and electrocardiogram (ECG) monitoring without warnings), and the control group (BP and ECG monitoring only during baseline and routine check-ups). The primary objective of the study is to evaluate the effectiveness of the intervention in improving blood pressure control and reducing the risk of electrocardiogram abnormalities, as well as understanding its underlying biological mechanisms.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Issuing health risk warning for a heat waves or cold spells; Device: A digital heat or cold health risk early warning tool; Device: Self-monitoring blood pressure and ECG device; Behavioral: Perform daily self-monitoring of their BP and ECG

Detailed Description

This cluster-randomized trial will be conducted in various districts across Tianjin, China. As part of the early warning interventions for heat and cold, three communities from each of the two selected districts will be randomly chosen and assigned to one of three groups: the combined intervention group, the self-monitoring group, or the control group. The study will be divided into pre-intervention and intervention phases. The pre-intervention period for the heat wave health early-warning information intervention spans from July 1st, 2023, to July 7th, 2023, followed by the intervention period from July 8th to September 9th, 2023. Similarly, during the cold spell health early-warning information intervention, the pre-intervention phase occurs from December 1st, 2023, to December 7th, 2023, and the intervention.

Participants in the combined intervention group will receive heat health risk warnings via digital tools, specifically a WeChat mini-program, providing real-time updates on early warnings and health advisories. Additionally, they will be instructed to perform daily self-monitoring of their blood pressure (BP) and electrocardiogram (ECG) using automated home devices. Participants in the self-monitoring alone group will engage in daily BP and ECG monitoring but not receive any health warnings. In contrast, the control group will monitor their BP and ECG only during baseline assessments and routine health check-ups (the day after the first heat wave in July and August 2023, as well as following the first cold spell in January and February 2024).

All participants will be required to record their daily time-activity patterns. During the baseline and subsequent check-ups, data will be collected on participants' demographics, medical history, lifestyle factors (e.g., diet, smoking, physical activity), environmental exposures, sleep quality, mental health status (including stress levels, emotional stability, and psychological resilience), medication adherence, cardiovascular and cerebrovascular symptoms, respiratory system symptoms, and perceptions of heatwaves and cold spells. In addition, blood, urine, and stool samples will be gathered for further analysis.

• Study Type: Interventional
• Enrollment (Actual): 342
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Individuals aged 60 to 65 years Individuals with a diagnosis of hypertension Individuals with untreated blood pressure above 140/90 mm Hg

Exclusion Criteria:

Having a history of coronary heart disease, heart failure, or stroke Unable to cooperate with follow-up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Combined intervention; Participants in the combined intervention group will receive real-time health risk warnings for heat waves and cold spells via a WeChat mini-program and will perform daily self-monitoring of BP and ECG using automated home devices.	Behavioral: Issuing health risk warning for a heat waves or cold spells; Whenever a health risk warning for a heat waves or cold spells is issued, only the elderly in the combined intervention group will be alerted to the early warning information through the digital heat or cold health risk early warning tool.; Device: A digital heat or cold health risk early warning tool; A WeChat mini-program provides real-time updates on early warnings and health advisories.; Device: Self-monitoring blood pressure and ECG device; Devices for self-monitoring blood pressure and ECG; Behavioral: Perform daily self-monitoring of their BP and ECG; Participants in the self-monitoring alone group were instructed to self-measure their BP three times each morning (from 6:00 a.m. to 8:00 a.m.) and evening (from 6:00 p.m. to 8:00 p.m.) at home, and to self-administer ECG measurements twice during the same morning and evening timeframes.
Other: Self-monitoring alone	Device: Self-monitoring blood pressure and ECG device; Devices for self-monitoring blood pressure and ECG; Behavioral: Perform daily self-monitoring of their BP and ECG; Participants in the self-monitoring alone group were instructed to self-measure their BP three times each morning (from 6:00 a.m. to 8:00 a.m.) and evening (from 6:00 p.m. to 8:00 p.m.) at home, and to self-administer ECG measurements twice during the same morning and evening timeframes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in DBP	The DBP was measured by a self-monitored electronic sphygmomanometer (Model Maibobo, Shenzhen Yike Network Technology Co., Ltd., China).	baseline, six months
Change from baseline in SBP	The SBP was measured by a self-monitored electronic sphygmomanometer (Model Maibobo, Shenzhen Yike Network Technology Co., Ltd., China).	baseline, six months
Change from baseline in the risk of the overall warning level for abnormal ECG.	Overall warning level for abnormal ECG is measured by a handheld electrocardiographic recorder, CarePatch (ECG-H01, Hangzhou Proton Technology Co., Ltd., China). This device is employed to assess and report on the presence of abnormal ECG states.	baseline, six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the control rate of blood pressure (SBP/DBP <120/80 mm Hg)	The blood pressure was measured by a self-monitored electronic sphygmomanometer (Model Maibobo, Shenzhen Yike Network Technology Co., Ltd., China). The proportion of participants achieving a systolic blood pressure (SBP) below 120 mm Hg and a diastolic blood pressure (DBP) below 80 mm Hg is calculated by dividing the number of participants who meet these criteria by the total number of participants at baseline and each routine health check-up.	baseline, six months
Change from baseline in the control rate of blood pressure (SBP/DBP <140/90 mm Hg)	The blood pressure was measured by a self-monitored electronic sphygmomanometer (Model Maibobo, Shenzhen Yike Network Technology Co., Ltd., China). The proportion of participants achieving a systolic blood pressure (SBP) below 140 mm Hg and a diastolic blood pressure (DBP) below 90 mm Hg is calculated by dividing the number of participants who meet these criteria by the total number of participants at baseline and each routine health check-up.	baseline, six months
Change from baseline in left ventricular hypertrophy	The trained staff use a handheld electrocardiographic recorder, CarePatch (ECG-H01, Hangzhou Proton Technology Co., Ltd., China) to measure the participants' the change of left ventricular hypertrophy.	baseline, six months
Change from baseline in sinus arrhythmia	The trained staff use a handheld electrocardiographic recorder, CarePatch (ECG-H01, Hangzhou Proton Technology Co., Ltd., China) to measure the participants' the change of sinus arrhythmia.	baseline, six months
Change from baseline in right bundle branch block	The trained staff use a handheld electrocardiographic recorder, CarePatch (ECG-H01, Hangzhou Proton Technology Co., Ltd., China) to measure the participants' the change of right bundle branch block.	baseline, six months
Change from baseline in ventricular premature beats	The trained staff use a handheld electrocardiographic recorder, CarePatch (ECG-H01, Hangzhou Proton Technology Co., Ltd., China) to measure the participants' the change of ventricular premature beats.	baseline, six months
Change from baseline in atrial premature beats	The trained staff use a handheld electrocardiographic recorder, CarePatch (ECG-H01, Hangzhou Proton Technology Co., Ltd., China) to measure the participants' the change of atrial premature beats.	baseline, six months
Change from baseline in Q waves	The trained staff use a handheld electrocardiographic recorder, CarePatch (ECG-H01, Hangzhou Proton Technology Co., Ltd., China) to measure the participants' the change of Q waves.	baseline, six months
Change from baseline in T-wave changes	The trained staff use a handheld electrocardiographic recorder, CarePatch (ECG-H01, Hangzhou Proton Technology Co., Ltd., China) to measure the participants' the change of T-wave changes.	baseline, six months
Change from baseline in ST changes	The trained staff use a handheld electrocardiographic recorder, CarePatch (ECG-H01, Hangzhou Proton Technology Co., Ltd., China) to measure the participants' the change of ST changes.	baseline, six months
Change from baseline in the heat wave and cold spell perception score	The heat wave and cold spell perception score is measured by the heat wave and cold spell perception questionnaire. This questionnaire captures participants' perceptions of heatwave-related health risks and their level of preparedness. Respondents rate their responses on a continuous scale from 0 to 100, with 0 representing "not at all" or "very low" and 100 representing "very much" or "very high," allowing them to express the degree of their perception and concern.	baseline, six months
Change from baseline in the PSQI score	The PSQI score is measured by the pittsburgh sleep quality index questionnaire. The PSQI consists of 19 individual items that assess seven key components of sleep: subjective sleep quality, sleep latency (the time it takes to fall asleep), sleep duration, habitual sleep efficiency (the ratio of total sleep time to time spent in bed), sleep disturbances, use of sleep medication, and daytime dysfunction.Each of the seven components is scored from 0 to 3, with the total PSQI score ranging from 0 to 21. A total score greater than 5 indicates poor sleep quality, while a lower score suggests good sleep quality.	baseline, six months
Change from baseline in the PHQ-9 score	The PHQ-9 score is measured by Patient Health Questionnaire-9. This questionnaire evaluates nine key symptoms of depression experienced over the past two weeks, including loss of interest or pleasure in activities, feeling down or hopeless, trouble sleeping, fatigue, poor appetite or overeating, feelings of worthlessness or failure, difficulty concentrating, physical agitation or slowing, and thoughts of self-harm or suicide. Each symptom is rated on a scale from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27. Scores of 5, 10, 15, and 20 indicate mild, moderate, moderately severe, and severe depression, respectively.	baseline, six months
Change from baseline in the MMSE score	The MMSE score is measured by the mini-mental state examination. This examination evaluates five main areas: orientation (to time and place), memory (short-term and long-term), attention and calculation (concentration and basic arithmetic), language (fluency and comprehension), and executive function (complex task performance). Each area is scored on a scale from 0 to 5, with a total score ranging from 0 to 30. Typically, a score above 24 indicates normal cognitive function, while a score below 24 may suggest cognitive impairment.	baseline, six months
Change from baseline in the GAD-7 score	The GAD-7 score is measured by the generalized anxiety disorder scale. This scale evaluates seven key symptoms of anxiety: feeling nervous, anxious, or on edge; not being able to stop or control worrying; worrying too much about different things; trouble relaxing; being so restless that it is hard to sit still; becoming easily annoyed or irritable; and feeling afraid as if something awful might happen. Each symptom is rated on a scale from 0 (not at all) to 3 (nearly every day), resulting in a total score ranging from 0 to 21. A score of 5 or above indicates the presence of generalized anxiety disorder symptoms, with higher scores reflecting greater symptom severity.	baseline, six months
Change from baseline in the PSSS score	The PSSS score is measured by the perceived social support scale. This scale evaluates three key sources of support: family, friends, and significant others. It consists of 12 items, with four items each related to family, friends, and significant others. Participants rate their agreement with each statement on a scale from 1 (very strongly disagree) to 7 (very strongly agree), resulting in a total score ranging from 12 to 84, where higher scores indicate higher perceived social support.	baseline, six months
Change from baseline in time-activity patterns	The time-activity patterns is measured by the self-reported time-activity diaries questionnaire. This questionnaire captures duration spent in various settings (such as outdoor environments, workplaces, transportation, home, and other indoor areas) and at different intensity levels of physical activity were recorded.	baseline, six months
Change from baseline in HPSMBRS score	The HPSMBRS score is measured by the hypertension patient self-management behavior rating scale. The HPSMBRS consists of 33 individual items across six dimensions: medication management, condition monitoring, dietary management, exercise management, work-rest management, and emotional management. Each item is rated on a 1 to 5 Likert scale, with 1 indicating "never" and 5 indicating "always." The total score ranges from 33 to 165, with higher scores indicating better self-management. To ensure comparability across dimensions, individual scores are converted to standardized scores using the formula: standardized score = (actual ctual score of each factor / total score of each factor)×100. Self-management levels are categorized as low (<60), moderate (60~80), and high (>80) based on standardized scores.	baseline, six months
Change from baseline in HPMARS score	The HPMARS score is measured by the hypertension patient medication adherence rating scale. The HPMARS consists of 8 individual items that assess key components of medication adherence: forgetting to take medication, intentional non-adherence, reducing or stopping medication due to side effects without consulting a doctor, forgetting medication during travel, forgetting to take medication the previous day, reducing dosage after symptoms are controlled, inconvenience of daily medication with maintaining adherence, and the frequency of forgetting to take medication. Each item is scored as 1 or 0, with the total HPMARS score ranging from 0 to 8. A total score of 8 indicates high adherence, 6 to 7 indicates moderate adherence, and a score below 6 suggests low adherence.	baseline, six months
Changes in liver function biomarkers (e.g., albumin (ALB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), etc.) from baseline	This section evaluates changes in liver function biomarkers using appropriate omics technologies to explore their potential role in liver-related diseases.	baseline, six months
Changes in kidney function biomarkers (e.g., uric acid (UA), blood urea nitrogen (BUN), creatinine (CREA), etc.) from baseline	This section assesses changes in kidney function biomarkers through suitable omics techniques, investigating their involvement in kidney disorders.	baseline, six months
Changes in cardiovascular biomarkers (e.g., creatine kinase-MB (CK-MB), creatine kinase (CK), etc.) from baseline	This section assesses changes in cardiovascular function biomarkers through suitable omics techniques, investigating their involvement in cardiovascular diseases.	baseline, six months
Changes in inflammatory biomarkers (e.g., interleukin-6 (IL-6), interleukin-1β (IL-1β), etc.) from baseline	This section examines the alterations in inflammatory biomarkers using relevant omics approaches, aiming to uncover their potential role in inflammatory and immune responses.	baseline, six months
Changes in metabolic biomarkers (e.g., lactate dehydrogenase (LDH), high-density lipoprotein (HDL), low-density lipoprotein cholesterol (LDL) , etc.) from baseline	This section examines the alterations in metabolic biomarkers using relevant omics approaches, aiming to uncover their potential implications in metabolic processes and health outcomes.	baseline, six months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): 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): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• 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