An interventional study of Telemedicine and Usual care in Hypertension, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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:
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's planned enrollment of 364 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Telemedicine
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.
Other: Usual care
a mobile app and telemedicine platform to confirm good blood pressure control and may save doctor face-to-face consultation
Participants will be followed up as usual by face-to-face consultation with the doctors
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.
Time frame: from the enrollment at 12-months
Ambulatory blood pressure readings
This will include ABPM parameters (24-h/daytime/nighttime SBP and DBP)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: from enrollment at 6-month and 12-month
serum creatinine
Serum creatinine will be collected to check kidney function
Time frame: 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.
Time frame: 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.
Time frame: from enrollment at 12 month
Total cholesterol level
Total cholesterol level will be collected to check lipid levels
Time frame: from enrollment at 12 month
Total triglyceride level
Total triglyceride level will be collected to check lipid levels.
Time frame: from enrollment at 12 month
Low-density lipoprotein level
Low-density lipoprotein level will be collected to check lipid levels
Time frame: from enrollment at 12 month
High-density lipoprotein level
High-density lipoprotein level will be collected to check lipid levels.
Time frame: from enrollment at 12 month
Hemoglobin A1C level
Hemoglobin A1C level will be collected to check blood glucose.
Time frame: from enrollment at 12 month
Fasting glucose level
Fasting glucose level will be collected to check blood glucose.
Time frame: 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.
Time frame: 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.
Time frame: from enrollment at 12-month
Hospitalization
Hospitalization will be retrieved from the computerised clinical management system (CMS). This is to measure healthcare utilization.
Time frame: from enrollment at 12-month
Visits to private hospitals
Visits to private hospitals will be self-reported. This is to measure healthcare utilization.
Time frame: from enrollment at 12-month
Visits to private clinics
Visits to private clinics will be self-reported. This is to measure healthcare utilization.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: from enrollment at 12-month
Plan to share: Undecided — May be available after discussion with other researchers
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Chinese University of Hong Kong