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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04542564
Acronym
SATE-HT
Enrollment
50
Registered
2020-09-09
Start date
2020-10-07
Completion date
2021-12-31
Last updated
2022-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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

Interventions

DEVICEtelemedicine

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

OTHERusual care

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

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

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

* 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,

Design outcomes

Primary

MeasureTime frameDescription
rate of recruitmentbaselinenumber of patients recruited per month during the recruitment period
rate of retentionbaseline, 6-monthnumber of dropouts during the 6-month study period
acceptabilityat 6-monthinterview of around 20 patients in the intervention group

Secondary

MeasureTime frameDescription
medication and diet adherencebaseline, 6-monthTreatment Adherence Questionnaire for Patients with Hypertension (TAQPH); Score was summed to give a total range, higher score represented better adherence
exercise levelbaseline, 6-monthGodin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ); higher scores represented higher exercise level
blood pressure levels on 24-hour ambulatory blood pressurebaseline, 6-monthdaytime, nighttime, and 24-hour systolic and diastolic blood pressure
health literacybaseline, 6-month3-item Brief Health Literacy; higher scores represented higher health literacy
eHealth literacybaseline, 6-monthChinese 8-item eHealth literacy scale; higher scores represented higher eHealth literacy
healthcare utilization6-monthnumber of visits to general outpatient clinic, specialist clinic(s) and hospitalization during study period
self-efficacy scalebaseline, 6-month5-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

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026