HypertensionSATE-HTNCT04542564
TElemedicine to Replace Face-to-face Physician Consultation in Patients With HyperTension : a Pilot Randomized-controlled Trial
A study testing telemedicine in people with Hypertension, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- telemedicine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 7 Oct 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- telemedicine, usual care
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telemedicineDevice
a mobile app and telemedicine platform to confirm good blood pressure control and may save doctor face-to-face consultation
usual careOther
These patients have unrestricted access to healthcare resources such as general outpatient clinics and emergency departments
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of recruitment
number of patients recruited per month during the recruitment period
Measured: baseline
rate of retention
number of dropouts during the 6-month study period
Measured: baseline, 6-month
acceptability
interview of around 20 patients in the intervention group
Measured: at 6-month
Secondary outcomes (7)
blood pressure levels on 24-hour ambulatory blood pressure
daytime, nighttime, and 24-hour systolic and diastolic blood pressure
Measured: baseline, 6-month
healthcare utilization
number of visits to general outpatient clinic, specialist clinic(s) and hospitalization during study period
Measured: 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
Measured: 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
Measured: baseline, 6-month
exercise level
Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ); higher scores represented higher exercise level
Measured: baseline, 6-month
eHealth literacy
Chinese 8-item eHealth literacy scale; higher scores represented higher eHealth literacy
Measured: baseline, 6-month
health literacy
3-item Brief Health Literacy; higher scores represented higher health literacy
Measured: baseline, 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start7 Oct 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Kam Pui, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542564
- Sponsor's protocol ID
- SATE-HT
- Acronym
- SATE-HT
- Status last verified
- Mar 2022
- First submitted
- 2 Sep 2020
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: May be available when inquired by other researchers
Publications
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.
PubMed 36905441
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04542564
- Acronym / sponsor ID
- SATE-HT / SATE-HT
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telemedicine group | Experimental | Device: telemedicine, Other: usual careThe 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 | Placebo comparator | Other: usual carePatients in the usual care group will be asked to refrain from downloading or using any health care apps related to HT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telemedicinea mobile app and telemedicine platform to confirm good blood pressure control and may save doctor face-to-face consultation | Device | telemedicine group |
| usual careThese patients have unrestricted access to healthcare resources such as general outpatient clinics and emergency departments | Other | telemedicine group, usual care |
Primary outcome
rate of recruitment
Time frame: baseline
number of patients recruited per month during the recruitment period
rate of retention
Time frame: baseline, 6-month
number of dropouts during the 6-month study period
acceptability
Time frame: at 6-month
interview of around 20 patients in the intervention group
7 secondary outcomes
blood pressure levels on 24-hour ambulatory blood pressure
Time frame: baseline, 6-month
healthcare utilization
Time frame: 6-month
self-efficacy scale
Time frame: baseline, 6-month
medication and diet adherence
Time frame: baseline, 6-month
exercise level
Time frame: baseline, 6-month
eHealth literacy
Time frame: baseline, 6-month
health literacy
Time frame: baseline, 6-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Derived from this study: PubMed 36905441Wang 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.
- Individual participant dataSharing planned: Undecided. May be available when inquired by other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telemedicine in people with Hypertension, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of recruitment (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04542564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.