NCT06524180招募中不适用
Can TElemedicine System Replace Doctor Consultations to Achieve Non-inferior Blood Pressure in Patients With Controlled Hypertension (TEACH)? a Randomised Controlled Trial and Cost-minimization Analysis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 364
- 试验地点
- 2
- 主要终点
- daytime systolic blood pressure
研究概览
简要总结
The goal of this clinical trial is to evaluate whether patients assigned to the telemedicine (HealthCap) group demonstrate non-inferior blood pressure (BP) control compared to patients in the usual care group at 12 months. The main question it aims to answer is:
- Do participants in telemedicine group have non-inferior daytime ambulatory blood pressure readings at 12-month, compared to usual care group?
- Do participants in telemedicine group have better HT treatment, higher self-efficacy, reduced number of visits to primary care clinics and similar health care utilisation other than GOPCs, compared to usual care group?
Participant in telemedicine group will:
- Receive reminders to measure 7-day home blood pressure before their index consultation.
- Get their drug refilled automatically as well as have consultations deferred 16-18 weeks later, if their blood pressure is under optimal control.
- Have consultations as scheduled, if their BP is suboptimal or any of the safety questions screen positive.
Participants in control group will:
- Have consultation with physicians every 16-18 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(i) having a diagnosis of essential HT;
- •(ii) on anti-HT medications;
- •(iii) well-controlled HT on out-of-office BP measurements, including HBPM or ambulatory blood pressure measurements (ABPM) (measurement algorithm and details under methods). ABPM or HBPM are preferred to office BP due to their superior reproducibility and predictivity to cardiovascular outcomes. Furthermore, office BP misclassifies 30-40% of patients as having suboptimal BP control due to white-coat effect. From our pilot study, some patients with optimal BP are reluctant to undergo ABPM before recruitment into the RCT, and HBPM is more acceptable to these patients and is therefore included. According to local and international guidelines, optimal out-of-office daytime BP should be <135/85 mmHg for patients without comorbidities and <130/85 mmHg for patients with comorbidities that increase cardiovascular risk (i.e. stroke, ischaemic heart diseases, heart failure, diabetes mellitus (DM), and chronic kidney diseases) respectively;
- •(iv) can read basic Chinese (language used in the HealthCap);
- •(v) have used any mobile app (not HT-related) in the previous 1 year; and
- •(vii) aged between 18-80.
排除标准
- •(i) cannot provide informed consent;
- •(ii) unwillingness to conduct HBPM or repeated ABPM;
- •(iii) relative contraindications to ABPM (i.e., diagnosed atrial fibrillation, nighttime workers, occupational drivers, or patients with bleeding tendencies);
- •(iv) have severe mental illnesses that impair their ability to use HealthCap, including those diagnosed with schizophrenia, dementia, or as being actively suicidal;
- •(v) a diagnosis of other acute or chronic diseases that need regular physical assessments and/or medication changes (e.g., suboptimally controlled DM [e.g., glycosylated haemoglobin (HbA1c)≥7%], depression requiring medications, active cancer); and (vi) predicted lifespan of <1 year.
结局指标
主要结局
daytime systolic blood pressure
时间窗: from the enrollment at 12-months
WatchBP O3 (Microlife AG, Switerzland) has been validated by multiple HT societies (www.stridebp.org) and will be used in the current RCT. BP will be measured every 30 min for ≥24 h, and patients' sleep diary will define the sleep duration. The readings will be considered valid if there are \>70% of valid readings overall, \>20 valid awake, and \>7 valid asleep BP readings in 24-h intervals.
次要结局
- Visits to private clinics(from enrollment at 12-month)
- Fasting glucose level(from enrollment at 12 month)
- Treatment adherence(from enrollment at 6-month and 12-month)
- Self-efficacy(from enrollment at 6 month and 12 month)
- serum creatinine(from enrollment at 12 month)
- High-density lipoprotein level(from enrollment at 12 month)
- Hemoglobin A1C level(from enrollment at 12 month)
- Acceptability(from enrollment at 12-month)
- Height(from enrollment at 12 month)
- Total triglyceride level(from enrollment at 12 month)
- Low-density lipoprotein level(from enrollment at 12 month)
- Number of antihypertensive drug use(from enrollment at 12-month)
- Patients' productivity loss(from enrollment at 12-month)
- Health-related quality of life(from enrollment at 6-month and 12-month)
- Total cholesterol level(from enrollment at 12 month)
- Visits to private hospitals(from enrollment at 12-month)
- Body weight(from enrollment at 12 month)
- Ambulatory blood pressure readings(from enrollment at 12-month)
- Satisfaction with HealthCap(from enrollment at 12 month)
- Visit to emergency department(from enrollment at 12-month)
- Hospitalization(from enrollment at 12-month)
- Visit to general outpatient clinics (GOPC)(from enrollment at 12-month)
- Type of antihypertensive drug use(from enrollment at 12-month)
研究者
Lee Kam Pui
Clinical associate professor
Chinese University of Hong Kong
研究点 (2)
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