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

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

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.

Study Overview

• Status: Completed
• Conditions: Health Promotion; Hyperuricemia; Sleep Quality; Type 2 Diabetes Mellitus (T2DM); Hypertension (HTN); Hypercholesterolemia and Hyperlipidemia; Overweight (BMI > 25)
• Intervention / Treatment: Device: Digital Health Program with Smart Devices

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 199
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan
    • Taoyuan District, Taoyuan, Taiwan, 333
      • Chang Gung Memorial Hospital, Linkou Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group (Digital Health Program); Participants in this arm used smart devices to measure physiological data, including blood pressure, blood glucose, uric acid, cholesterol, and electrocardiograms. The data were automatically uploaded to a cloud-based health management platform. Physicians reviewed the data monthly and provided personalized consultations and health education during the 6-month intervention period.	Device: Digital Health Program with Smart Devices; 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.
No Intervention: Control Group - Usual Care; Participants in this arm received usual community health care and did not use smart devices or the digital health management platform. No additional physician consultations or structured health education sessions were provided beyond the standard community health services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fasting Blood Glucose	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).	Baseline, 3 months, 6 months
Change in Blood Pressure (Systolic and Diastolic)	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).	Baseline, 3 months, 6 months
Change in Serum Uric Acid	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.	Baseline, 3 months, 6 months
Change in Body Mass Index (BMI)	Measurement: Weight (kg) / height² (m²). Range: 10-60 kg/m². Directionality: Higher values indicate greater adiposity. Abnormal threshold: ≥ 24 kg/m² (Taiwanese overweight criterion).	Baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Fat Percentage	Measurement range: 5-60 %. Directionality: Higher values indicate worse body-composition status. Abnormal threshold: ≥ 25 % (men) or ≥ 30 % (women).	Baseline, 3 months, 6 months
Change in Visceral Fat Rating	Scale range: 1-59 points. Directionality: Higher scores indicate worse (greater) visceral-fat accumulation. Abnormal threshold: ≥ 10 points.	Baseline, 3 months, 6 months
Change in Skeletal Muscle Mass Index (ASMI)	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.	Baseline, 3 months, 6 months
Change in Self-Rated Health Status	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.	Baseline, 3 months, 6 months
Change in Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)	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.	Baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: October 1, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Pathologic Processes; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Dyslipidemias; Lipid Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Hypertension; Diabetes Mellitus, Type 2; Hyperuricemia; Sleep Initiation and Maintenance Disorders; Hypercholesterolemia; Hyperlipidemias
• Other Study ID Numbers: 202201534B0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We have not made a final decision on sharing individual participant data (IPD). Data sharing will depend on institutional policies and participant privacy considerations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No