Can TElemedicine System Replace Doctor Consultations to Achieve Non-inferior Blood Pressure in Patients with Controlled Hypertension
NCT Number: NCT06524180
Acronym: TEACH
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension
Sponsor: Chinese University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 364
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2027-09

Summary:
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:

* Do participants in telemedicine group have non-inferior daytime ambulatory blood pressure readings at 12-month, compared to usual care group?
* Do participants in telemedicine group have better HT treatment, higher self-efficacy, reduced number of visits to primary care clinics and similar health care utilisation other than GOPCs, compared to usual care group?

Participant in telemedicine group will:

* Receive reminders to measure 7-day home blood pressure before their index consultation.
* Get their drug refilled automatically as well as have consultations deferred 16-18 weeks later, if their blood pressure is under optimal control.
* Have consultations as scheduled, if their BP is suboptimal or any of the safety questions screen positive.

Participants in control group will:

* Have consultation with physicians every 16-18 weeks.

Primary Outcome Measures: 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
Secondary Outcome Measures: 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), 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