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

NCT ID: NCT04542564

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-07
• Study Completion Date: 2021-12-31

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

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

telemedicine

Intervention Type: DEVICE

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

usual care

Intervention Type: OTHER

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

usual care

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

Group Type: PLACEBO_COMPARATOR

usual care

Intervention Type: OTHER

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

Interventions

telemedicine

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

Intervention Type: DEVICE

usual care

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

Intervention Type: OTHER

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Lee Kam Pui

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lek Yuen Clinic and Fanling clinic

Hong Kong, , Hong Kong

Countries

Hong Kong

References

Wang S, Leung M, Leung SY, Han J, Leung W, Hui E, Mihailidou AS, Kam-Fai Tsoi K, Chi-Sang Wong M, Wong SY, Lee EK. Safety, Feasibility, and Acceptability of Telemedicine for Hypertension in Primary Care: A Proof-of-concept and Pilot Randomized Controlled Trial (SATE-HT). J Med Syst. 2023 Mar 11;47(1):34. doi: 10.1007/s10916-023-01933-4.

Reference Type: DERIVED

PMID: 36905441 (View on PubMed)

Other Identifiers

SATE-HT

Identifier Type: -

Identifier Source: org_study_id