Hypertension (HTN)NCT07238257
Effectiveness of Digital Health Intervention on Community Health Care in Middle-aged and Older Population in Taiwan
A study testing Digital Health Program with Smart Devices in people with Hypertension (HTN) and Type 2 Diabetes Mellitus (T2DM), run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension (HTN), Type 2 Diabetes Mellitus (T2DM), Hyperuricemia
- What is being tested?
- Digital Health Program with Smart Devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 50 years and older
- Resided in the community for at least 6 months
- Able and willing to provide written informed consent
Who cannot join
- Severe cognitive impairment
- Terminal illness
- Inability to operate basic digital devices (e.g., smartphone, health monitoring device)
- Declined to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension (HTN), Type 2 Diabetes Mellitus (T2DM), Hyperuricemia, Hypercholesterolemia and Hyperlipidemia, Overweight (BMI > 25), Sleep Quality
- Being tested
- Digital Health Program with Smart Devices
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2, Hyperuricemia, Hypercholesterolemia, Hyperlipidemias, Overweight, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Health Program with Smart DevicesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Baseline, 3 months, 6 months
Secondary outcomes (5)
Change in Body Fat Percentage
Measurement range: 5-60 %. Directionality: Higher values indicate worse body-composition status. Abnormal threshold: ≥ 25 % (men) or ≥ 30 % (women).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Dec 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238257
- Sponsor's protocol ID
- 202201534B0
- Status last verified
- Sep 2025
- First submitted
- 1 Oct 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have not made a final decision on sharing individual participant data (IPD). Data sharing will depend on institutional policies and participant privacy considerations.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Digital Health Interventions on Community Health Care Among Middle-aged and Elderly Population in Taiwan: 6-month Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT07238257
- Acronym / sponsor ID
- 202201534B0
- Conditions
- Hypertension (HTN), Type 2 Diabetes Mellitus (T2DM), Hyperuricemia, Hypercholesterolemia and Hyperlipidemia, Overweight (BMI > 25), Sleep Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Digital Health Program) | Experimental | Device: Digital Health Program with Smart DevicesParticipants 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. |
| 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 50 years and older
- Resided in the community for at least 6 months
- Able and willing to provide written informed consent
Key exclusion criteria (4 listed)
- Severe cognitive impairment
- Terminal illness
- Inability to operate basic digital devices (e.g., smartphone, health monitoring device)
- Declined to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Health Program with Smart DevicesParticipants 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. | Device | Intervention Group (Digital Health Program) |
Primary outcome
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).
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).
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.
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).
5 secondary outcomes
Change in Body Fat Percentage
Time frame: Baseline, 3 months, 6 months
Change in Visceral Fat Rating
Time frame: Baseline, 3 months, 6 months
Change in Skeletal Muscle Mass Index (ASMI)
Time frame: Baseline, 3 months, 6 months
Change in Self-Rated Health Status
Time frame: Baseline, 3 months, 6 months
Change in Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)
Time frame: Baseline, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: Undecided. We have not made a final decision on sharing individual participant data (IPD). Data sharing will depend on institutional policies and participant privacy considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Health Program with Smart Devices in people with Hypertension (HTN) and Type 2 Diabetes Mellitus (T2DM), run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fasting Blood Glucose (time frame: Baseline, 3 months, 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.