Early-warning Intervention for Heat and Cold in Older Hypertensive Patients: Impact on Sleep Quality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 378
- 试验地点
- 1
- 主要终点
- Change from baseline in the PSQI score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 60 to 65 years Individuals with a diagnosis of hypertension Individuals with untreated blood pressure above 140/90 mm Hg
排除标准
- •Having a history of coronary heart disease, heart failure, or stroke Unable to cooperate with follow-up
研究组 & 干预措施
Combined intervention
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.
干预措施: Issuing health risk warning for a heat or cold (Behavioral)
Combined intervention
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.
干预措施: A digital heat or cold health risk early warning tool (Device)
Combined intervention
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.
干预措施: Perform daily self-monitoring of their BP and ECG (Behavioral)
Combined intervention
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.
干预措施: Self-monitoring blood pressure and ECG device (Device)
Self-monitoring alone
干预措施: Perform daily self-monitoring of their BP and ECG (Behavioral)
Self-monitoring alone
干预措施: Self-monitoring blood pressure and ECG device (Device)
Control
结局指标
主要结局
Change from baseline in the PSQI score
时间窗: baseline, six months
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.
次要结局
- 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)
- 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)
- Change from baseline in atrial premature beats(baseline, six months)
- Change from baseline in Q waves(baseline, six months)
- Change from baseline in T-wave changes(baseline, six months)
- Change from baseline in ventricular premature beats(baseline, six months)
- Change from baseline in ST changes(baseline, six months)
- Change from baseline in the heat wave and cold spell perception score(baseline, six months)
- Change from baseline in the PHQ-9 score(baseline, six months)
- Change from baseline in the MMSE score(baseline, six months)
- Change from baseline in the GAD-7 score(baseline, six months)
- Change from baseline in the PSSS score(baseline, six months)
- Change from baseline in time-activity patterns(baseline, six months)
- Change from baseline in HPSMBRS score(baseline, six months)
- Change from baseline in HPMARS score(baseline, six months)
- Changes in liver function biomarkers (e.g., albumin (ALB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), etc.) from baseline(baseline, six months)
- Changes in cardiovascular biomarkers (e.g., creatine kinase-MB (CK-MB), creatine kinase (CK), etc.) from baseline(baseline, six months)
- Changes in inflammatory biomarkers (e.g., interleukin-6 (IL-6), interleukin-1β (IL-1β), etc.) from baseline(baseline, six months)
- Changes in metabolic biomarkers (e.g., lactate dehydrogenase (LDH), high-density lipoprotein (HDL), low-density lipoprotein cholesterol (LDL) , etc.) from baseline(baseline, six months)
研究者
Tiantian Li
professor
Centers for Disease Control and Prevention, China