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Completed

NCT Number: NCT04542564

TElemedicine to Replace Face-to-face Physician Consultation in Patients With HyperTension : a Pilot Randomized-controlled Trial

The investigators has developed a blood pressure telemonitoring system. It is hypothesized that, when optimal control of BP is confirmed on the telemonitoring system, the index physician's consultation can be safely deferred, and medications can still be prescribed without such face-to-face consultation. Despite potentially resource-saving for doctors and time-saving for patients, the feasibility and patients' acceptability of the use of the telemonitoring system to replace face-to-face physician consultation remains unclear.

For primary outcome, the investigators hypothesize that this telemonitoring system will be feasible and acceptable to patients and can replace physicians' face-to-face consultations. For secondary outcomes, the investigators hypothesize that patients receiving care through telemonitoring have non-inferior BP control when compared with patients receiving usual care. Furthermore, the patients receiving telemonitoring may also have enhanced self-efficacy and compliance to drugs and lifestyle interventions

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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

Lek Yuen Clinic and Fanling clinic

Hong Kong

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • have a diagnosis of essential hypertension (HT) and are currently taking antihypertensive agents
  • have good control of clinic BP as confirmed on ambulatory blood pressure monitoring (ABPM) (daytime BP ≤135/85mmHg)
  • can read basic Chinese (as the content of the app in Chinese)
  • have a home BP monitor (HBPM)
  • used any mobile app (not HT-related) in the previous 1 year

Exclusion criteria

  • an inability to give informed consent
  • unwillingness to conduct HBPM or repeated ABPM
  • current use of any other HT app for BP monitoring
  • relative contraindications to ABPM (diagnosed atrial fibrillation, occupational drivers or patients with bleeding tendencies)
  • severe mental illness, including those diagnosed with schizophrenia, dementia or as being actively suicidal, because these patients may have diminished ability to use the HT app;
  • a diagnosis of other chronic disease(s) that need regular physical assessments and doctors' consultations (e.g. diabetes and asthma that are being treated, but patients with hypertension and hyperlipidaemia will remain eligible)
  • diagnosed active cancer,

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

These patients have unrestricted access to healthcare resources such as general outpatient clinics and emergency departments

Primary outcomes

  1. rate of recruitment

    Time frame: baseline

    number of patients recruited per month during the recruitment period

  2. rate of retention

    Time frame: baseline, 6-month

    number of dropouts during the 6-month study period

  3. acceptability

    Time frame: at 6-month

    interview of around 20 patients in the intervention group

Secondary outcomes

  1. blood pressure levels on 24-hour ambulatory blood pressure

    Time frame: baseline, 6-month

    daytime, nighttime, and 24-hour systolic and diastolic blood pressure

  2. healthcare utilization

    Time frame: 6-month

    number of visits to general outpatient clinic, specialist clinic(s) and hospitalization during study period

  3. self-efficacy scale

    Time frame: baseline, 6-month

    5-item self-efficacy scale specific to hypertension; a mean score from the items of a 9 or above were classified as having good self-efficacy

  4. medication and diet adherence

    Time frame: baseline, 6-month

    Treatment Adherence Questionnaire for Patients with Hypertension (TAQPH); Score was summed to give a total range, higher score represented better adherence

  5. exercise level

    Time frame: baseline, 6-month

    Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ); higher scores represented higher exercise level

  6. eHealth literacy

    Time frame: baseline, 6-month

    Chinese 8-item eHealth literacy scale; higher scores represented higher eHealth literacy

  7. health literacy

    Time frame: baseline, 6-month

    3-item Brief Health Literacy; higher scores represented higher health literacy

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Safety, Feasibility and Acceptability of Using TElemedicine to Replace Face-to-face Physician Consultation in Patients With HyperTension in Hong Kong: a Pilot Randomized-controlled Trial

Acronym: SATE-HT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 9, 2020
Registry last updated
Mar 9, 2022

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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