Early-warning Intervention for Heat and Cold in Older Hypertensive Patients: Impact on Blood Pressure and ECG
NCT06011213 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 342
Last updated 2025-01-24
Summary
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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
Tiantian Li
lead OTHER_GOV
Principal Investigators
-
Tiantian Li · National lnstitute of Environmental Health, Chinese Center for Disease Controland Prevention
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-07-01
- Primary Completion
- 2024-02-28
- Completion
- 2024-02-28
Countries
- China
Study Locations
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