Clinical trial NCT06524180: Can TElemedicine System Replace Doctor Consultations to Achieve Non-inferior Blood Pressure in Patients With Controlled Hypertension
Official title: Can TElemedicine System Replace Doctor Consultations to Achieve Non-inferior Blood Pressure in Patients With Controlled Hypertension (TEACH)? a Randomised Controlled Trial and Cost-minimization Analysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: blood pressure
telemedicine
home blood pressure measurement
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 \&lt;135/85 mmHg for patients without comorbidities and \&lt;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 \&lt;1 year.

Primary outcomes:
measure: daytime systolic blood pressure
timeFrame: from the enrollment at 12-months
Secondary outcomes:
measure: Ambulatory blood pressure readings
timeFrame: from enrollment at 6-month
measure: Ambulatory blood pressure readings
timeFrame: from enrollment at 12-month
measure: Treatment adherence
timeFrame: from enrollment at 6-month and 12-month
measure: Self-efficacy
timeFrame: from enrollment at 6 month and 12 month
measure: Satisfaction with HealthCap
timeFrame: from enrollment at 12 month
measure: Acceptability
timeFrame: from enrollment at 12-month
measure: Health-related quality of life
timeFrame: from enrollment at 6-month and 12-month
measure: serum creatinine
timeFrame: from enrollment at 12 month
measure: Body weight
timeFrame: from enrollment at 12 month
measure: Height
timeFrame: from enrollment at 12 month
measure: Total cholesterol level
timeFrame: from enrollment at 12 month
measure: Total triglyceride level
timeFrame: from enrollment at 12 month
measure: Low-density lipoprotein level
timeFrame: from enrollment at 12 month
measure: High-density lipoprotein level
timeFrame: from enrollment at 12 month
measure: Hemoglobin A1C level
timeFrame: from enrollment at 12 month
measure: Fasting glucose level
timeFrame: from enrollment at 12 month
measure: Visit to general outpatient clinics (GOPC)
timeFrame: from enrollment at 12-month
measure: Visit to emergency department
timeFrame: from enrollment at 12-month
measure: Hospitalization
timeFrame: from enrollment at 12-month
measure: Visits to private hospitals
timeFrame: from enrollment at 12-month
measure: Visits to private clinics
timeFrame: from enrollment at 12-month
measure: Number of antihypertensive drug use
timeFrame: from enrollment at 12-month
measure: Type of antihypertensive drug use
timeFrame: from enrollment at 12-month
measure: Patients' productivity loss
timeFrame: from enrollment at 12-month
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: HKW and NTEC GOPC
Study officials:
References: