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

NCT04542564 | Completed

• 1 other identifier: SATE-HT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• blood pressure levels on 24-hour ambulatory blood pressure

  baseline, 6-month

• healthcare utilization

  6-month

• self-efficacy scale

  baseline, 6-month

• medication and diet adherence

  baseline, 6-month

• exercise level

  baseline, 6-month

Study Arms (2)

telemedicine group

EXPERIMENTAL

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; Other: usual care

usual care

PLACEBO COMPARATOR

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

Interventions

telemedicine DEVICE

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

telemedicine group

usual care OTHER

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

telemedicine group; usual care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Lek Yuen Clinic and Fanling clinic

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 36905441 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 9, 2020
• Study Start: October 7, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 9, 2022

Record last verified: 2022-03

Locations

HK (1)