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Completed

NCT Number: NCT07238257

Effectiveness of Digital Health Intervention on Community Health Care in Middle-aged and Older Population in Taiwan

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.

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Key information

Conditions

Hypertension (HTN) Body Weight Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Health Promotion Hypercholesterolemia Hypercholesterolemia and Hyperlipidemia Hyperlipidemias Hypertension Hyperuricemia Lipid Metabolism Disorders Mental Disorders Metabolic Diseases Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Overweight (BMI > 25) Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Quality Sleep Wake Disorders Type 2 Diabetes Mellitus (T2DM) Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital, Linkou Branch

Taoyuan, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 50 years and older
  • Resided in the community for at least 6 months
  • Able and willing to provide written informed consent

Exclusion criteria

  • Severe cognitive impairment
  • Terminal illness
  • Inability to operate basic digital devices (e.g., smartphone, health monitoring device)
  • Declined to provide informed consent

Treatment and study plan

Digital Health Program with Smart Devices

Device

Participants in the intervention group used smart devices to measure physiological parameters, including blood pressure, blood glucose, uric acid, cholesterol, and electrocardiograms. These data were automatically uploaded to a cloud-based health management platform. Physicians reviewed the data monthly and provided personalized consultations and health education for 6 months.

Primary outcomes

  1. Change in Fasting Blood Glucose

    Time frame: 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).

  2. Change in Blood Pressure (Systolic and Diastolic)

    Time frame: 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).

  3. Change in Serum Uric Acid

    Time frame: 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.

  4. Change in Body Mass Index (BMI)

    Time frame: 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).

Secondary outcomes

  1. Change in Body Fat Percentage

    Time frame: Baseline, 3 months, 6 months

    Measurement range: 5-60 %. Directionality: Higher values indicate worse body-composition status. Abnormal threshold: ≥ 25 % (men) or ≥ 30 % (women).

  2. Change in Visceral Fat Rating

    Time frame: Baseline, 3 months, 6 months

    Scale range: 1-59 points. Directionality: Higher scores indicate worse (greater) visceral-fat accumulation.

    Abnormal threshold: ≥ 10 points.

  3. Change in Skeletal Muscle Mass Index (ASMI)

    Time frame: Baseline, 3 months, 6 months

    Measurement: Skeletal-muscle mass / height² (kg/m²). Typical range: 4.0-10.0 kg/m². Directionality: Higher values indicate better muscle mass. Cut-offs (AWGS 2019): < 7.0 kg/m² (men) or < 5.7 kg/m² (women) = low muscle mass.

  4. Change in Self-Rated Health Status

    Time frame: Baseline, 3 months, 6 months

    Scale title: Self-Rated Health Scale (single-item global health question). Scale range: 1 = Excellent, 2 = Good, 3 = Fair, 4 = Poor, 5 = Very Poor. Directionality: Higher scores indicate worse perceived overall health.

  5. Change in Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)

    Time frame: Baseline, 3 months, 6 months

    Scale title: Pittsburgh Sleep Quality Index (PSQI), 19-item standardized questionnaire evaluating sleep over the previous month.

    Scale range: 0-21 points. Directionality: Higher scores indicate worse sleep quality. Interpretation: Total score > 5 = poor sleep quality.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Effectiveness of Digital Health Interventions on Community Health Care Among Middle-aged and Elderly Population in Taiwan: 6-month Cluster Randomized Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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