Clinical trial NCT06045403: Early-Warning Intervention for Heat and Cold in Older Hypertensive Patients: Impact on Sleep Quality
Official title: Early-warning Intervention for Heat and Cold in Older Hypertensive Patients: Impact on Sleep Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Centers for Disease Control and Prevention, China
Sponsor class: OTHER_GOV
First posted: 2023-09-21
Enrollment: 378
Sex: ALL
Minimum age (years): 60
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: This cluster-randomized trial will be conducted in various districts across Tianjin, China. As part of the early warning interventions for heat waves and cold spells, three communities from each of the two selected districts will be randomly chosen and assigned to one of three groups: the combined intervention group, the self-monitoring group, or the control group. The study will be divided into pre-intervention and intervention phases. The pre-intervention period for the heat wave health early-warning information intervention spans from July 1st, 2023, to July 7th, 2023, followed by the intervention period from July 8th to September 9th, 2023. Similarly, during the cold spell health early-warning information intervention, the pre-intervention phase occurs from December 1st, 2023, to December 7th, 2023, and the intervention.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change from baseline in the PSQI score
timeFrame: baseline, six months
Secondary outcomes:
measure: Change from baseline in the control rate of blood pressure (SBP/DBP <140/90 mm Hg)
timeFrame: baseline, six months
measure: Change from baseline in the risk of the overall warning level for abnormal ECG.
timeFrame: baseline, six months
measure: Change from baseline in the control rate of blood pressure (SBP/DBP <120/80 mm Hg)
timeFrame: baseline, six months
measure: Change from baseline in SBP
timeFrame: baseline, six months
measure: Change from baseline in DBP
timeFrame: baseline, six months
measure: Change from baseline in left ventricular hypertrophy
timeFrame: baseline, six months
measure: Change from baseline in sinus arrhythmia
timeFrame: baseline, six months
measure: Change from baseline in right bundle branch block
timeFrame: baseline, six months
measure: Change from baseline in ventricular premature beats
timeFrame: baseline, six months
measure: Change from baseline in atrial premature beats
timeFrame: baseline, six months
measure: Change from baseline in Q waves
timeFrame: baseline, six months
measure: Change from baseline in T-wave changes
timeFrame: baseline, six months
measure: Change from baseline in ST changes
timeFrame: baseline, six months
measure: Change from baseline in the heat wave and cold spell perception score
timeFrame: baseline, six months
measure: Change from baseline in the PHQ-9 score
timeFrame: baseline, six months
measure: Change from baseline in the MMSE score
timeFrame: baseline, six months
measure: Change from baseline in the GAD-7 score
timeFrame: baseline, six months
measure: Change from baseline in the PSSS score
timeFrame: baseline, six months
measure: Change from baseline in time-activity patterns
timeFrame: baseline, six months
measure: Change from baseline in HPSMBRS score
timeFrame: baseline, six months
measure: Change from baseline in HPMARS score
timeFrame: baseline, six months
measure: Changes in liver function biomarkers (e.g., albumin (ALB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), etc.) from baseline
timeFrame: baseline, six months
measure: Changes in cardiovascular biomarkers (e.g., creatine kinase-MB (CK-MB), creatine kinase (CK), etc.) from baseline
timeFrame: baseline, six months
measure: Changes in inflammatory biomarkers (e.g., interleukin-6 (IL-6), interleukin-1β (IL-1β), etc.) from baseline
timeFrame: baseline, six months
measure: Changes in metabolic biomarkers (e.g., lactate dehydrogenase (LDH), high-density lipoprotein (HDL), low-density lipoprotein cholesterol (LDL) , etc.) from baseline
timeFrame: baseline, six months
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Institute of Environmental Health, Chinese Center for Disease Control and Prevention
Study officials:
affiliation: National lnstitute of Environmental Health, Chinese Center for Disease Controland Prevention
name: Tiantian Li
role: STUDY_DIRECTOR
References: