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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Device: telemedicine; Other: usual care

• Registration Number: NCT04542564
• Lead Sponsor: Chinese University of Hong Kong

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-02
• Study First Posted: 2020-09-09
• Study Start: 2020-10-07
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
telemedicine group	usual care	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
usual care	usual care	Patients in the usual care group will be asked to refrain from downloading or using any health care apps related to HT
telemedicine group	telemedicine	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lek Yuen Clinic and Fanling clinic; 🇭🇰 Hong Kong, Hong Kong