Clinical trial NCT04542564: TElemedicine to Replace Face-to-face Physician Consultation in Patients With HyperTension : a Pilot Randomized-controlled Trial
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 50
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 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


Eligibility criteria: 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,

Primary outcomes:
measure: rate of recruitment
timeFrame: baseline
measure: rate of retention
timeFrame: baseline, 6-month
measure: acceptability
timeFrame: at 6-month
Secondary outcomes:
measure: blood pressure levels on 24-hour ambulatory blood pressure
timeFrame: baseline, 6-month
measure: healthcare utilization
timeFrame: 6-month
measure: self-efficacy scale
timeFrame: baseline, 6-month
measure: medication and diet adherence
timeFrame: baseline, 6-month
measure: exercise level
timeFrame: baseline, 6-month
measure: eHealth literacy
timeFrame: baseline, 6-month
measure: health literacy
timeFrame: baseline, 6-month
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Lek Yuen Clinic and Fanling clinic
Study officials:
References: