Effectiveness of Digital Health Interventions on Community Health Care Among Middle-aged and Elderly Population in Taiwan: 6-month Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- Change in Fasting Blood Glucose
研究概览
简要总结
This study aims to evaluate the effectiveness of a digital health intervention for community-dwelling middle-aged and older adults in Taiwan. A total of 199 participants from four randomly selected communities will be enrolled in a 6-month cluster randomized trial. Participants in the intervention group will use smart devices to record physiological data, which are automatically uploaded to a cloud-based health management platform. Physicians will review the data monthly and provide personalized consultations and health education. Primary outcomes include anthropometric measures, biochemical indices, electrocardiograms, and self-reported health and sleep quality.
详细描述
This 6-month cluster randomized trial is conducted in Guishan District, Taoyuan City, Taiwan, to examine the impact of a digital health intervention on community health outcomes among adults aged 50 years and older.
From 32 eligible communities, four are randomly selected. Participants must have resided in the community for at least six months, be aged 50 years or older, and provide informed consent. Individuals with severe cognitive impairment, terminal illness, or an inability to use basic digital devices are excluded.
Participants in the intervention group will use smart devices to measure blood pressure, fasting glucose, uric acid, total cholesterol, and electrocardiograms. The data are automatically synchronized with a cloud-based health management platform. Physicians will review data monthly and provide individualized consultations and health education sessions at baseline, 3 months, and 6 months.
Primary outcomes include anthropometric indices (BMI, body fat percentage, visceral fat rating, skeletal muscle mass index), biochemical markers (fasting glucose, uric acid, cholesterol), and self-reported health and sleep quality. Secondary outcomes include trends in physiological indicators and associations among cardiometabolic risk factors.
Ethical approval was obtained from the Institutional Review Board of Chang Gung Memorial Hospital (IRB No.: 202201534B0). Written informed consent is obtained from all participants.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 50 years and older
- •Resided in the community for at least 6 months
- •Able and willing to provide written informed consent
排除标准
- •Severe cognitive impairment
- •Terminal illness
- •Inability to operate basic digital devices (e.g., smartphone, health monitoring device)
- •Declined to provide informed consent
结局指标
主要结局
Change in Fasting Blood Glucose
时间窗: Baseline, 3 months, 6 months
Measurement: Laboratory glucose value in milligrams per deciliter (mg/dL). Range: Typically 50-500 mg/dL observed in human plasma. Directionality: Higher values indicate worse glycemic control. Abnormal thresholds: FPG ≥ 100 mg/dL or PPG ≥ 140 mg/dL (American Diabetes Association criteria).
Change in Blood Pressure (Systolic and Diastolic)
时间窗: Baseline, 3 months, 6 months
Measurement: Systolic (mmHg) and diastolic (mmHg). Range: 70-250 mmHg (SBP); 40-150 mmHg (DBP). Directionality: Higher values indicate worse blood-pressure control. Abnormal threshold: SBP ≥ 130 mmHg or DBP ≥ 80 mmHg (2017 ACC/AHA guideline).
Change in Serum Uric Acid
时间窗: Baseline, 3 months, 6 months
Measurement: Serum uric-acid concentration (mg/dL). Range: 2-12 mg/dL. Directionality: Higher values indicate worse metabolic status. Abnormal threshold: \> 7.0 mg/dL.
Change in Body Mass Index (BMI)
时间窗: Baseline, 3 months, 6 months
Measurement: Weight (kg) / height² (m²). Range: 10-60 kg/m². Directionality: Higher values indicate greater adiposity. Abnormal threshold: ≥ 24 kg/m² (Taiwanese overweight criterion).
次要结局
- Change in Body Fat Percentage(Baseline, 3 months, 6 months)
- Change in Visceral Fat Rating(Baseline, 3 months, 6 months)
- Change in Skeletal Muscle Mass Index (ASMI)(Baseline, 3 months, 6 months)
- Change in Self-Rated Health Status(Baseline, 3 months, 6 months)
- Change in Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)(Baseline, 3 months, 6 months)