Early-warning Intervention for Heat and Cold in Older Hypertensive Patients: Impact on Blood Pressure and ECG
NCT ID: NCT06011213
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
342 participants
INTERVENTIONAL
2023-07-01
2024-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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.
A digital heat or cold health risk early warning tool
A WeChat mini-program provides real-time updates on early warnings and health advisories.
Self-monitoring blood pressure and ECG device
Devices for self-monitoring blood pressure and ECG
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.
Self-monitoring alone
Self-monitoring blood pressure and ECG device
Devices for self-monitoring blood pressure and ECG
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.
Control
No interventions assigned to this group
Interventions
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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.
A digital heat or cold health risk early warning tool
A WeChat mini-program provides real-time updates on early warnings and health advisories.
Self-monitoring blood pressure and ECG device
Devices for self-monitoring blood pressure and ECG
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
60 Years
65 Years
ALL
Yes
Sponsors
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Tiantian Li
OTHER_GOV
Responsible Party
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Tiantian Li
professor
Principal Investigators
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Tiantian Li
Role: STUDY_DIRECTOR
National lnstitute of Environmental Health, Chinese Center for Disease Controland Prevention
Locations
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National Institute of Environmental Health, Chinese Center for Disease Control and Prevention
Beijing, , China
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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202361
Identifier Type: -
Identifier Source: org_study_id
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