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

NCT06011213 | Completed

• 1 other identifier: 202361
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 1

Brief 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

Hypertension

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (24)

• Change from baseline in the control rate of blood pressure (SBP/DBP <120/80 mm Hg)

  baseline, six months

• Change from baseline in the control rate of blood pressure (SBP/DBP <140/90 mm Hg)

  baseline, six months

• Change from baseline in left ventricular hypertrophy

  baseline, six months

• Change from baseline in sinus arrhythmia

  baseline, six months

• Change from baseline in right bundle branch block

  baseline, six months

Study Arms (3)

Combined intervention

EXPERIMENTAL

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; 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

Self-monitoring alone

OTHER

Device: Self-monitoring blood pressure and ECG device; Behavioral: Perform daily self-monitoring of their BP and ECG

Control

NO INTERVENTION

Interventions

Issuing health risk warning for a heat waves or cold spells BEHAVIORAL

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.

Combined intervention

A digital heat or cold health risk early warning tool DEVICE

A WeChat mini-program provides real-time updates on early warnings and health advisories.

Combined intervention

Self-monitoring blood pressure and ECG device DEVICE

Devices for self-monitoring blood pressure and ECG

Combined intervention; Self-monitoring alone

Perform daily self-monitoring of their BP and ECG BEHAVIORAL

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.

Combined intervention; Self-monitoring alone

Eligibility Criteria

• Age: 60 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tiantian Li: lead

Study Sites (1)

National Institute of Environmental Health, Chinese Center for Disease Control and Prevention

Beijing, 100021, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

Blood Pressure Monitoring, Ambulatory; epicatechin gallate

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Pressure Determination; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Tiantian Li

  National lnstitute of Environmental Health, Chinese Center for Disease Controland Prevention

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: August 25, 2023
• Study Start: July 1, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

CN (1)