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

NCT07238257 | Completed

• 1 other identifier: 202201534B0
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension (HTN); Type 2 Diabetes Mellitus (T2DM); Hyperuricemia; Hypercholesterolemia and Hyperlipidemia; Overweight (BMI > 25); Sleep Quality; Health Promotion

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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

Study Arms (2)

Intervention Group (Digital Health Program)

EXPERIMENTAL

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

Control Group - Usual Care

NO INTERVENTION

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.

Interventions

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.

Intervention Group (Digital Health Program)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital, Linkou Branch

Taoyuan District, Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2; Hyperuricemia; Hypercholesterolemia; Hyperlipidemias; Overweight; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dyslipidemias; Lipid Metabolism Disorders; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: November 20, 2025
• Study Start: December 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 20, 2025

Record last verified: 2025-09

Locations

TW (1)