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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- rate of retention
研究概览
简要总结
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
- •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
排除标准
- •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,
结局指标
主要结局
rate of retention
时间窗: baseline, 6-month
number of dropouts during the 6-month study period
rate of recruitment
时间窗: baseline
number of patients recruited per month during the recruitment period
acceptability
时间窗: at 6-month
interview of around 20 patients in the intervention group
次要结局
- blood pressure levels on 24-hour ambulatory blood pressure(baseline, 6-month)
- eHealth literacy(baseline, 6-month)
- healthcare utilization(6-month)
- health literacy(baseline, 6-month)
- medication and diet adherence(baseline, 6-month)
- exercise level(baseline, 6-month)
- self-efficacy scale(baseline, 6-month)
研究者
Lee Kam Pui
Clinical Assistant Professor
Chinese University of Hong Kong