Mobile Sipoo a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in blood pressure
研究概览
简要总结
Mobile Sipoo is a randomized controlled trial aiming to improve selfcare and outcomes of diabetes and hypertensive patients by introducing a remote patient monitoring system supported with automatic patient decision support. The feedback system is coupled with back-office health coaching.
详细描述
Self-monitored data from blood pressure meters (SMBP), glucometers (SMBG), scales and pedometers are transferred by mobile phone terminals to a tethered personal health record (PHR) integrated with the provider EHR. The PHR application includes tools to display of self-monitoring data.
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
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of diabetes or hypertension made at least 6 months prior to inclusion to study.
- •For hypertensive patients: Blood pressure over 140/90 mmHg (systolic and diastolic separately) treated or untreated
- •Diabetes patients: Glycohemoglobin A1c over 6.5% but lower that 11%
- •use of diabetes medication
排除标准
- •Patients who decline to participate
- •Patients specifically excluded by the health centre physician
- •Patients unable to co-operate, expected poor study compliance (IT illiterate) or reluctance to perform self monitoring
- •Pregnancy
- •Patients with a life expectance of less than one year
- •Patients with major elective surgery planned within 6 months or patient has had major surgery within last 2 months.
- •Patients with psychiatric disorders (depression), abuse of alcohol or narcotics complicating or disabling participation in the study
研究组 & 干预措施
Control group
Control group received usual care
Telemonitoring group
Intervention patients were given a remote patient monitoring toolbox that included a mobile telephone, software application, and assessment devices for measuring and remote reporting of hypertension and diabetes -related health parameters at home. The monitored parameters were body weight, steps, blood pressure and blood glucose. Based on their self-monitored data, patients received feedback that was automatically generated, theory-based, health promotion rich information that aimed at strengthening their self-care practices.
干预措施: Intervention group (Device)
结局指标
主要结局
Change in blood pressure
时间窗: 9 months
Change in Hba1c(for diabetes patients)
时间窗: 9 months
次要结局
- Change in medication(9 months)
- Change in FÍNSIK scores(9 months)
- Achieving the desired target range(9 months)
- Adverse effects(9 months)
- Hypoglycemia(9 months)
- Change in body weight(9 months)
- Change in BMI(9 months)