Early-Warning Intervention for Heat and Cold in Older Hypertensive Patients: Impact on Sleep Quality

NCT06045403 | Completed

• 1 other identifier: 202381
• Study Type: interventional
• Target: 378
• 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, the self-monitoring group, and the control group. The primary objective of the study is to evaluate the effectiveness of the intervention in improving sleep quality, as well as understanding its underlying biological mechanisms.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the PSQI score

  The PSQI score is measured by the pittsburgh sleep quality index questionnaire. The PSQI consists of 19 individual items that assess seven key components of sleep: subjective sleep quality, sleep latency (the time it takes to fall asleep), sleep duration, habitual sleep efficiency (the ratio of total sleep time to time spent in bed), sleep disturbances, use of sleep medication, and daytime dysfunction.Each of the seven components is scored from 0 to 3, with the total PSQI score ranging from 0 to 21. A total score greater than 5 indicates poor sleep quality, while a lower score suggests good sleep quality.

  baseline, six months

Secondary Outcomes (25)

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

  baseline, six months

• Change from baseline in the risk of the overall warning level for abnormal ECG.

  baseline, six months

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

  baseline, six months

• Change from baseline in SBP

  baseline, six months

• Change from baseline in DBP

  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 or cold; Device: A digital heat or cold health risk early warning tool; Behavioral: Perform daily self-monitoring of their BP and ECG; Device: Self-monitoring blood pressure and ECG device

Self-monitoring alone

EXPERIMENTAL

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

Control

NO INTERVENTION

Interventions

Issuing health risk warning for a heat or cold BEHAVIORAL

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.

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

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

Self-monitoring blood pressure and ECG device DEVICE

Devices for self-monitoring blood pressure and electrocardiography (ECG).

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

Cold Temperature; epicatechin gallate; Blood Pressure Monitoring, Ambulatory

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; 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: September 10, 2023
• First Posted: September 21, 2023
• Study Start: July 1, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Locations

CN (1)