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NCT Number: NCT06524180

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

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.

Recruiting

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HKW and NTEC GOPC

Hong Kong

Location status: Recruiting

Location contact

Eric Kam-Pui Lee, MSc

CONTACT

[email protected]

22528462

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telemedicine

Device

a mobile app and telemedicine platform to confirm good blood pressure control and may save doctor face-to-face consultation

Usual Care

Other

Participants will be followed up as usual by face-to-face consultation with the doctors

Primary outcomes

  1. daytime systolic blood pressure

    Time frame: 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 outcomes

  1. Ambulatory blood pressure readings

    Time frame: from enrollment at 6-month

    This will include ABPM parameters (24-h/daytime/nighttime SBP and DBP)

  2. Ambulatory blood pressure readings

    Time frame: from enrollment at 12-month

    ABPM parameters other than daytime SBP at 12-month (24-h/nighttime SBP/DBP and daytime DBP)

  3. Treatment adherence

    Time frame: 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.

  4. Self-efficacy

    Time frame: 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.

  5. Satisfaction with HealthCap

    Time frame: 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

  6. Acceptability

    Time frame: 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.

  7. Health-related quality of life

    Time frame: 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).

  8. serum creatinine

    Time frame: from enrollment at 12 month

    Serum creatinine will be collected to check kidney function

  9. Body weight

    Time frame: 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.

  10. Height

    Time frame: 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.

  11. Total cholesterol level

    Time frame: from enrollment at 12 month

    Total cholesterol level will be collected to check lipid levels

  12. Total triglyceride level

    Time frame: from enrollment at 12 month

    Total triglyceride level will be collected to check lipid levels.

  13. Low-density lipoprotein level

    Time frame: from enrollment at 12 month

    Low-density lipoprotein level will be collected to check lipid levels

  14. High-density lipoprotein level

    Time frame: from enrollment at 12 month

    High-density lipoprotein level will be collected to check lipid levels.

  15. Hemoglobin A1C level

    Time frame: from enrollment at 12 month

    Hemoglobin A1C level will be collected to check blood glucose.

  16. Fasting glucose level

    Time frame: from enrollment at 12 month

    Fasting glucose level will be collected to check blood glucose.

  17. Visit to general outpatient clinics (GOPC)

    Time frame: from enrollment at 12-month

    Visits to GOPC will be retrieved from the computerised clinical management system (CMS). This is to measure healthcare utilization.

  18. Visit to emergency department

    Time frame: 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.

  19. Hospitalization

    Time frame: from enrollment at 12-month

    Hospitalization will be retrieved from the computerised clinical management system (CMS). This is to measure healthcare utilization.

  20. Visits to private hospitals

    Time frame: from enrollment at 12-month

    Visits to private hospitals will be self-reported. This is to measure healthcare utilization.

  21. Visits to private clinics

    Time frame: from enrollment at 12-month

    Visits to private clinics will be self-reported. This is to measure healthcare utilization.

  22. Number of antihypertensive drug use

    Time frame: 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.

  23. Type of antihypertensive drug use

    Time frame: 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.

  24. Patients' productivity loss

    Time frame: from enrollment at 12-month

    Patients' productivity loss (e.g. loss of work days due to doctors' visits) will be self-reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Kam Pui Lee

CONTACT

[email protected]

+85222528462

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Acronym: TEACH

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 29, 2024
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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