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

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Device: telemedicine; Other: usual care

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Lek Yuen Clinic and Fanling clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: telemedicine group; The HT app (HealthCap) allows patients to record their home BP measurements (HBPM) and can automatically provide mean BP values from the previous 7 or 30 days. 1-2 week prior to a scheduled physician, HealthCap and a research assistant will remind patients to take dual BP readings both in the morning and evening for 1 week for doctors' management. The mean values of the 7-day home BP will be checked before the index consultation. If the home BP control was optimal (i.e. ≤135/85 mmHg), other important parameters will be checked automatically by a questionnaire in the app: (i) if they have good drug compliance and if they experienced any side effects,(ii) if they have symptoms suggestive of target organ damages such as chest pain or hemiplegia, and (iii) if they have any problem(s) that need to consult a physician. If no complaints are identified, the patient can collect medications directly from the clinic and the physician appointment will be deferred for 3 months	Device: telemedicine; a mobile app and telemedicine platform to confirm good blood pressure control and may save doctor face-to-face consultation; Other: usual care; These patients have unrestricted access to healthcare resources such as general outpatient clinics and emergency departments
Placebo Comparator: usual care; Patients in the usual care group will be asked to refrain from downloading or using any health care apps related to HT	Other: usual care; These patients have unrestricted access to healthcare resources such as general outpatient clinics and emergency departments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of recruitment	number of patients recruited per month during the recruitment period	baseline
rate of retention	number of dropouts during the 6-month study period	baseline, 6-month
acceptability	interview of around 20 patients in the intervention group	at 6-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure levels on 24-hour ambulatory blood pressure	daytime, nighttime, and 24-hour systolic and diastolic blood pressure	baseline, 6-month
healthcare utilization	number of visits to general outpatient clinic, specialist clinic(s) and hospitalization during study period	6-month
self-efficacy scale	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	baseline, 6-month
medication and diet adherence	Treatment Adherence Questionnaire for Patients with Hypertension (TAQPH); Score was summed to give a total range, higher score represented better adherence	baseline, 6-month
exercise level	Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ); higher scores represented higher exercise level	baseline, 6-month
eHealth literacy	Chinese 8-item eHealth literacy scale; higher scores represented higher eHealth literacy	baseline, 6-month
health literacy	3-item Brief Health Literacy; higher scores represented higher health literacy	baseline, 6-month

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: SATE-HT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: May be available when inquired by other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No