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The goal of this clinical trial is to evaluate whether patients assigned to the telemedicine (HealthCap) group demonstrate non-inferior blood pressure (BP) control compared to patients in the usual care group at 12 months. The main question it aims to answer is:
Participant in telemedicine group will:
Participants in control group will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine | Experimental | Patients will be (i) given a validated HBPM device (ORMON HEM-7120) with appropriate cuff size, (ii) taught the HBPM technique, and (iii) taught to record HBPM readings using the HealthCap mobile app on their smartphones. Participants randomized to intervention will be reminded to take dual BP readings in the morning and evening for 1-2 weeks before the index consultation. These BP readings will be automatically sent to a computer at the clinic. When the HBPM mean is optimal (i.e., <135/85 mmHg or <130/80 mmHg [for patients with cardiovascular diseases, renal diseases, and DM]), other parameters will be checked using an online questionnaire. If no complaints are identified, the patient will have automatic drug refill and the physician appointment will be deferred for 16-18 weeks. |
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| Usual care | Active Comparator | Participants will continue receiving routine care, including anti-HT drug prescriptions, from their regular clinicians. In HK, patients with well-controlled HT are routinely seen every 16-18 weeks. Participants will also be given the same HBPM devices and taught the techniques. This is necessary because HBPM is a secondary outcome. According to the HK guidelines, all patients with HT are advised to regularly monitor their home BP, which can be considered as usual care.14 However, the patients will not be taught any BP measurement algorithm (such as that used in the telemedicine group). They will also be asked not to download or use any new HT mobile apps during the study period. In HK, all citizens have unlimited access to GOPCs and emergency departments for health problems. All participants are advised to seek medical help if BP becomes dangerously and persistently high (i.e. SBP ≥180 or DBP ≥110mmHg) or in case of any suspected medical emergencies. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine | Device | a mobile app and telemedicine platform to confirm good blood pressure control and may save doctor face-to-face consultation |
|
| Measure | Description | Time Frame |
|---|---|---|
| daytime systolic blood pressure | WatchBP O3 (Microlife AG, Switerzland) has been validated by multiple HT societies (www.stridebp.org) and will be used in the current RCT. BP will be measured every 30 min for ≥24 h, and patients' sleep diary will define the sleep duration. The readings will be considered valid if there are >70% of valid readings overall, >20 valid awake, and >7 valid asleep BP readings in 24-h intervals. | from the enrollment at 12-months |
| Measure | Description | Time Frame |
|---|---|---|
| Ambulatory blood pressure readings | This will include ABPM parameters (24-h/daytime/nighttime SBP and DBP) | from enrollment at 6-month |
| Ambulatory blood pressure readings | ABPM parameters other than daytime SBP at 12-month (24-h/nighttime SBP/DBP and daytime DBP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kam Pui Lee | Contact | +85222528462 | lkp032@cuhk.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HKW and NTEC GOPC | Recruiting | Hong Kong | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41361824 | Derived | Ng SN, Yip BH, Wang S, Leung M, Choi SYK, Leung SY, Han JJ, Tsui WW, Lai SY, Chan L, Mihailidou AS, McManus RJ, Sy J, Lee EK. Can TElemedicine system replace doctor consultations to Achieve non-inferior blood pressure in patients with Controlled Hypertension (TEACH)? Study protocol for a randomised controlled trial. Trials. 2025 Dec 8;27(1):31. doi: 10.1186/s13063-025-09350-3. |
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May be available after discussion with other researchers
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Usual care | Other | Participants will be followed up as usual by face-to-face consultation with the doctors |
|
| from enrollment at 12-month |
| Treatment adherence | This will be measured by the Treatment Adherence Questionnaire for patients with HT, which is validated in Chinese, and contains measurements of adherence to medications, diet, stimulation, weight control, exercise, and stress reduction. | from enrollment at 6-month and 12-month |
| Self-efficacy | This will be measured using the validated 5-item self-efficacy scale specific to HT, which was found to have good internal validity (Cronbach's alpha = 0.81) with a mean score of at least 9 (out of 10), signifying good self-efficacy. | from enrollment at 6 month and 12 month |
| Satisfaction with HealthCap | all participants in the intervention group will be asked to rank their satisfaction with HealthCap and with the automatic drug refill process on a scale from 0 (completely dissatisfied) to 10 (completely satisfied) at 12-m | from enrollment at 12 month |
| Acceptability | to assess the acceptability of the HealthCap system, around 30 patients with high (highest quartile score) and low (lowest quartile score) satisfaction will be invited to patients' interview till data saturation. Similarly, participating physicians (likely total number <30) will be interviewed, till data saturation if possible. | from enrollment at 12-month |
| Health-related quality of life | Their health-related quality of life will be assessed by the validated EQ5D-5L (needed for cost-effectiveness analysis if HealthCap is found superior than usual care). | from enrollment at 6-month and 12-month |
| serum creatinine | Serum creatinine will be collected to check kidney function | from enrollment at 12 month |
| Body weight | Body weight weight in kilograms will be collected to calculate body mass index. Weight and height will be combined to report BMI in kg/m^2. | from enrollment at 12 month |
| Height | Height in meters will be collected to calculate body mass index. Weight and height will be combined to report BMI in kg/m^2. | from enrollment at 12 month |
| Total cholesterol level | Total cholesterol level will be collected to check lipid levels | from enrollment at 12 month |
| Total triglyceride level | Total triglyceride level will be collected to check lipid levels. | from enrollment at 12 month |
| Low-density lipoprotein level | Low-density lipoprotein level will be collected to check lipid levels | from enrollment at 12 month |
| High-density lipoprotein level | High-density lipoprotein level will be collected to check lipid levels. | from enrollment at 12 month |
| Hemoglobin A1C level | Hemoglobin A1C level will be collected to check blood glucose. | from enrollment at 12 month |
| Fasting glucose level | Fasting glucose level will be collected to check blood glucose. | from enrollment at 12 month |
| Visit to general outpatient clinics (GOPC) | Visits to GOPC will be retrieved from the computerised clinical management system (CMS). This is to measure healthcare utilization. | from enrollment at 12-month |
| Visit to emergency department | Visit to emergency department will be retrieved from the computerised clinical management system (CMS). This is to measure healthcare utilization. | from enrollment at 12-month |
| Hospitalization | Hospitalization will be retrieved from the computerised clinical management system (CMS). This is to measure healthcare utilization. | from enrollment at 12-month |
| Visits to private hospitals | Visits to private hospitals will be self-reported. This is to measure healthcare utilization. | from enrollment at 12-month |
| Visits to private clinics | Visits to private clinics will be self-reported. This is to measure healthcare utilization. | from enrollment at 12-month |
| Number of antihypertensive drug use | Number of antihypertensive drug use will be retrieved from the computerised clinical management system. This is to measure healthcare utilization. | from enrollment at 12-month |
| Type of antihypertensive drug use | Type of antihypertensive drug use will be retrieved from the computerised clinical management system. This is to measure healthcare utilization. | from enrollment at 12-month |
| Patients' productivity loss | Patients' productivity loss (e.g. loss of work days due to doctors' visits) will be self-reported. | from enrollment at 12-month |