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

Hypertension Clinical Trial

— SATE-HT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04542564
• Other study ID #: SATE-HT
• Status: Completed
• Phase: N/A
• Start date: October 7, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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,

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Lek Yuen Clinic and Fanling clinic	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of recruitment	number of patients recruited per month during the recruitment period	baseline
Primary	rate of retention	number of dropouts during the 6-month study period	baseline, 6-month
Primary	acceptability	interview of around 20 patients in the intervention group	at 6-month
Secondary	blood pressure levels on 24-hour ambulatory blood pressure	daytime, nighttime, and 24-hour systolic and diastolic blood pressure	baseline, 6-month
Secondary	healthcare utilization	number of visits to general outpatient clinic, specialist clinic(s) and hospitalization during study period	6-month
Secondary	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
Secondary	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
Secondary	exercise level	Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ); higher scores represented higher exercise level	baseline, 6-month
Secondary	eHealth literacy	Chinese 8-item eHealth literacy scale; higher scores represented higher eHealth literacy	baseline, 6-month
Secondary	health literacy	3-item Brief Health Literacy; higher scores represented higher health literacy	baseline, 6-month