Hypertension
Conditions
Keywords
blood pressure, telemedicine, home blood pressure measurement
Brief 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.
Interventions
DEVICETelemedicine
a mobile app and telemedicine platform to confirm good blood pressure control and may save doctor face-to-face consultation
OTHERUsual care
Participants will be followed up as usual by face-to-face consultation with the doctors
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* (i) having a diagnosis of essential HT; * (ii) on anti-HT medications; * (iii) well-controlled HT on out-of-office BP measurements, including HBPM or ambulatory blood pressure measurements (ABPM) (measurement algorithm and details under methods). ABPM or HBPM are preferred to office BP due to their superior reproducibility and predictivity to cardiovascular outcomes. Furthermore, office BP misclassifies 30-40% of patients as having suboptimal BP control due to white-coat effect. From our pilot study, some patients with optimal BP are reluctant to undergo ABPM before recruitment into the RCT, and HBPM is more acceptable to these patients and is therefore included. According to local and international guidelines, optimal out-of-office daytime BP should be <135/85 mmHg for patients without comorbidities and <130/85 mmHg for patients with comorbidities that increase cardiovascular risk (i.e. stroke, ischaemic heart diseases, heart failure, diabetes mellitus (DM), and chronic kidney diseases) respectively; * (iv) can read basic Chinese (language used in the HealthCap); * (v) have used any mobile app (not HT-related) in the previous 1 year; and * (vii) aged between 18-80.
Exclusion criteria
* (i) cannot provide informed consent; * (ii) unwillingness to conduct HBPM or repeated ABPM; * (iii) relative contraindications to ABPM (i.e., diagnosed atrial fibrillation, nighttime workers, occupational drivers, or patients with bleeding tendencies); * (iv) have severe mental illnesses that impair their ability to use HealthCap, including those diagnosed with schizophrenia, dementia, or as being actively suicidal; * (v) a diagnosis of other acute or chronic diseases that need regular physical assessments and/or medication changes (e.g., suboptimally controlled DM \[e.g., glycosylated haemoglobin (HbA1c)≥7%\], depression requiring medications, active cancer); and (vi) predicted lifespan of <1 year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| daytime systolic blood pressure | from the enrollment at 12-months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment adherence | from enrollment at 6-month and 12-month | 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. |
| Self-efficacy | from enrollment at 6 month and 12 month | 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. |
| Satisfaction with HealthCap | from enrollment at 12 month | 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 |
| Acceptability | from enrollment at 12-month | 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. |
| Health-related quality of life | from enrollment at 6-month and 12-month | 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). |
| serum creatinine | from enrollment at 12 month | Serum creatinine will be collected to check kidney function |
| Body weight | from enrollment at 12 month | 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. |
| Height | from enrollment at 12 month | Height in meters will be collected to calculate body mass index. Weight and height will be combined to report BMI in kg/m\^2. |
| Total cholesterol level | from enrollment at 12 month | Total cholesterol level will be collected to check lipid levels |
| Total triglyceride level | from enrollment at 12 month | Total triglyceride level will be collected to check lipid levels. |
| Low-density lipoprotein level | from enrollment at 12 month | Low-density lipoprotein level will be collected to check lipid levels |
| Ambulatory blood pressure readings | from enrollment at 6-month | This will include ABPM parameters (24-h/daytime/nighttime SBP and DBP) |
| Hemoglobin A1C level | from enrollment at 12 month | Hemoglobin A1C level will be collected to check blood glucose. |
| Fasting glucose level | from enrollment at 12 month | Fasting glucose level will be collected to check blood glucose. |
| Visit to general outpatient clinics (GOPC) | from enrollment at 12-month | Visits to GOPC will be retrieved from the computerised clinical management system (CMS). This is to measure healthcare utilization. |
| Visit to emergency department | from enrollment at 12-month | Visit to emergency department will be retrieved from the computerised clinical management system (CMS). This is to measure healthcare utilization. |
| Hospitalization | from enrollment at 12-month | Hospitalization will be retrieved from the computerised clinical management system (CMS). This is to measure healthcare utilization. |
| Visits to private hospitals | from enrollment at 12-month | Visits to private hospitals will be self-reported. This is to measure healthcare utilization. |
| Visits to private clinics | from enrollment at 12-month | Visits to private clinics will be self-reported. This is to measure healthcare utilization. |
| Number of antihypertensive drug use | from enrollment at 12-month | Number of antihypertensive drug use will be retrieved from the computerised clinical management system. This is to measure healthcare utilization. |
| Type of antihypertensive drug use | from enrollment at 12-month | Type of antihypertensive drug use will be retrieved from the computerised clinical management system. This is to measure healthcare utilization. |
| Patients' productivity loss | from enrollment at 12-month | Patients' productivity loss (e.g. loss of work days due to doctors' visits) will be self-reported. |
| High-density lipoprotein level | from enrollment at 12 month | High-density lipoprotein level will be collected to check lipid levels. |
Countries
Hong Kong
Contacts
Primary ContactKam Pui Lee
Outcome results
None listed