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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06011213 on ClinicalTrials.gov