Early-Warning Intervention for Heat and Cold in Older Hypertensive Patients: Impact on Sleep Quality
NCT ID: NCT06045403
Last Updated: 2024-10-30
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
378 participants
INTERVENTIONAL
2023-07-01
2024-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Early-warning Intervention for Heat and Cold in Older Hypertensive Patients: Impact on Blood Pressure and ECG
NCT06011213
Passive Heat Therapy for Lowering Systolic Blood Pressure and Improving Vascular Function in Mid-life and Older Adults
NCT05300971
Effect of Smart Phone Based Telemonitoring on Blood Pressure Among Hypertensive Patients in Primary Care
NCT02046993
Home Blood Pressure Monitoring Registration Study in the Elderly(HOME Study)
NCT04212468
Heat Therapy in Older Hypertensive Women
NCT03857490
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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 or cold
Whenever a health risk warning for a heat or cold 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.
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 blood pressure and ECG device
Devices for self-monitoring blood pressure and electrocardiography (ECG).
Self-monitoring alone
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 blood pressure and ECG device
Devices for self-monitoring blood pressure and electrocardiography (ECG).
Control
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Issuing health risk warning for a heat or cold
Whenever a health risk warning for a heat or cold 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.
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 blood pressure and ECG device
Devices for self-monitoring blood pressure and electrocardiography (ECG).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
60 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tiantian Li
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tiantian Li
professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tiantian Li
Role: STUDY_DIRECTOR
National lnstitute of Environmental Health, Chinese Center for Disease Controland Prevention
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Institute of Environmental Health, Chinese Center for Disease Control and Prevention
Beijing, , China
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
202381
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.