Can TElemedicine System Replace Doctor Consultations to Achieve Non-inferior Blood Pressure in Patients With Controlled Hypertension

Chinese University of Hong Kong364 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

364

Conditions

Hypertension

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Can TElemedicine System Replace Doctor Consultations to Achieve Non-inferior Blood Pressure in Patients With Controlled Hypertension

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts