TElemedicine to Replace Face-to-face Physician Consultation in Patients With HyperTension : a Pilot Randomized-controlled Trial (SATE-HT)
2022年3月7日 更新者：Lee Kam Pui、Chinese University of Hong Kong
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
研究概览
研究类型
介入性
注册 (实际的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Hong Kong、香港
- Lek Yuen Clinic and Fanling clinic
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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,
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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
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a mobile app and telemedicine platform to confirm good blood pressure control and may save doctor face-to-face consultation
These patients have unrestricted access to healthcare resources such as general outpatient clinics and emergency departments
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安慰剂比较：usual care
Patients in the usual care group will be asked to refrain from downloading or using any health care apps related to HT
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These patients have unrestricted access to healthcare resources such as general outpatient clinics and emergency departments
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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rate of recruitment
大体时间：baseline
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number of patients recruited per month during the recruitment period
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baseline
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rate of retention
大体时间：baseline, 6-month
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number of dropouts during the 6-month study period
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baseline, 6-month
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acceptability
大体时间：at 6-month
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interview of around 20 patients in the intervention group
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at 6-month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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blood pressure levels on 24-hour ambulatory blood pressure
大体时间：baseline, 6-month
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daytime, nighttime, and 24-hour systolic and diastolic blood pressure
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baseline, 6-month
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healthcare utilization
大体时间：6-month
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number of visits to general outpatient clinic, specialist clinic(s) and hospitalization during study period
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6-month
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self-efficacy scale
大体时间：baseline, 6-month
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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
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baseline, 6-month
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medication and diet adherence
大体时间：baseline, 6-month
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Treatment Adherence Questionnaire for Patients with Hypertension (TAQPH); Score was summed to give a total range, higher score represented better adherence
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baseline, 6-month
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exercise level
大体时间：baseline, 6-month
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Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ); higher scores represented higher exercise level
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baseline, 6-month
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eHealth literacy
大体时间：baseline, 6-month
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Chinese 8-item eHealth literacy scale; higher scores represented higher eHealth literacy
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baseline, 6-month
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health literacy
大体时间：baseline, 6-month
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3-item Brief Health Literacy; higher scores represented higher health literacy
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baseline, 6-month
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年10月7日
初级完成 (实际的)
2021年12月31日
研究完成 (实际的)
2021年12月31日
研究注册日期
首次提交
2020年9月2日
首先提交符合 QC 标准的
2020年9月2日
首次发布 (实际的)
2020年9月9日
研究记录更新
最后更新发布 (实际的)
2022年3月9日
上次提交的符合 QC 标准的更新
2022年3月7日
最后验证
2022年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.