Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-29 @ 2:31 AM
Study NCT ID:
NCT07238257
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2025-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Digital Health Intervention on Community Health Care in Middle-aged and Older Population in Taiwan
Sponsor:
Chang Gung Memorial Hospital
Organization:
Study Overview
Official Title:
Effectiveness of Digital Health Interventions on Community Health Care Among Middle-aged and Elderly Population in Taiwan: 6-month Cluster Randomized Trial
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: