CHF Home Telemonitoring: A Home Telemonitoring Service for Chronic Heart Failure Patients on Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Additional costs/savings resulting from the service
研究概览
简要总结
Providing patients with chronic heart failure (CHF) access to remote monitoring, for example by telephone or telemonitoring using wireless technology, reduces deaths and hospitalisations and may provide benefits on health care costs and quality of life. Remote monitoring of patients with chronic heart failure can reduce pressure on resources, particularly for conditions like chronic heart failure, which exert a large burden on health services. These are conclusions of the Cochrane Systematic Review from 2010.
In Norway the costs for treatment of chronic heart failure are vast, both concerning hospital treatment, daily use of medication over years, and loss of quality of life for patients and their family caregivers. Generally there is little knowledge about what is gained for the billions used. In Norway no telemonitoring services are established and hence no investigations have yet been published. Thus it seems that current evidence of effectiveness and quality is insufficient to recommend usage. The structure and funding streams in Norwegian health services are different from other countries and the conventional services that the intervention has been compared to in previous studies, are most likely heterogeneous. It is thus important to investigate Norwegian conditions.
Advanced telemonitoring technology with electronic transfer of physiological data such as blood pressure and weight is currently being used in research and established routine services in several countries in Europe, amongst them the Netherlands, Germany and the United Kingdom.
The proposed project intends to introduce such a strategy as an avenue for exploring promising new services that would not otherwise be available in Norway. The service consists of daily monitoring the patients' weight and blood pressure directly from their home; automatically and securely transmit the values to a server at the University Hospital of North Norway (UNN); and monitor the values by a trained nurse at the Heart polyclinic.
The primary objective of this study is thus to explore whether, as compared to current care from the Heart Polyclinic, the introduction of home telemonitoring will reduce hospital readmissions and will, in addition, be cost-effective. This is in line with current directions of European telemonitoring programmes for patients with chronic heart failure. This result may define if the telemonitoring of heart failure patients is feasible for Norway or not at all.
详细描述
All data collected by the equipment placed at the patient's home will be directly and securely transferred to the Heart polyclinic of the University Hospital of North Norway (UNN). All data is anonymous as explained below, only the weight and the codes with the answers to the questionnaire are send.
Each day a nurse is assigned as responsible for the heart remote monitoring system. The nurse in charge must read the heart remote monitoring email in the morning every day, seven days a week. If an alert email has been received, then the nurse logs into the system's dashboard and reads the data displayed there for that patient. Then the nurse will try to phone the patient to clarify the situation. Until this moment the procedure protocol differs from the ordinary routines as the notification of a case is usually raised by a phone call from the patient or a hospitalisation. But from this moment on, the procedure protocol is the same as for all patients treated by the Heart polyclinic, i.e. if the nurse evaluates the situation to need a further follow-up, then the nurse contacts the patient's general practitioner (GP) by phone (as said this is procedure as usual). The hospital's Heart polyclinic has the same responsibility for the treatment of the patients, both in the intervention arm and the control arm.
Each one of the patients assigned to the intervention arm will be following this procedure during 6 months. For the patients assigned to the control arm they will receive treatment as usual also during a period of 6 months. Data stored in the system is anonymised. All patients are uniquely identified by a number, the Unique Identifier (UID), in the system, the connection between the UID and the real identity being only stored in a file in a secured personal computer unconnected from any network, staying in an office at the heart polyclinic. Once a week, the UIDs' file stored in the study personal computer at the Heart polyclinic is transferred to a hardware protected pen drive. The pen drive in then placed in another building at the UNN. This procedure is of the responsibility of the UNN's department for "E-health and information and communications technology (ICT)". In this way only two copies of the file are stored in separate buildings. No reference to the study name is mentioned in this file.
As a pilot study, a prototype of the platform was built. It consisted of a wireless weight scale and also a blood pressure meter prepared to send the values through the home Wi-Fi network to a connected portable computer. The portable computer could then send the encrypted measurements to a server at UNN.
After the first two months of pilot testing, the patient was satisfied with the usability of the solution and the reliability of the service was proven.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of CHF signs and symptoms such as dyspnoea and peripheral or pulmonary oedema requiring diuretic administration (New York Heart Association [NYHA] functional class II-IV); and ejection fraction (EF) under 40% combined or not with a left ventricular filling pattern supporting the presence of diastolic dysfunction, according to the American College of Cardiology/American Heart Association Guidelines for chronic heart failure.
排除标准
- •Severe psychiatric disturbance diagnosed by DSM-IV-TR criteria. Any disability that may prevent the subject from completing the informed consent form or other study requirements.
- •Medication or drug dependency or abuse (except for nicotine). Inability to handle the technological devices included in the study, for some other reason.
研究组 & 干预措施
Usual care (control)
Patients assigned to the control arm receive treatment as usual, consisting of a recommendation to weigh themselves at home, using their own weight scale, and to report by phone to the polyclinic if there is a significant change in weight.
Telemonitoring (intervention)
an intervention arm testing the proposed telemonitoring service and a control arm with the current treatment.
Patients assigned to the intervention arm receive a home telemonitoring kit consisting of a tablet, a wireless weight scale and a portable blood pressure meter. The patient is asked to weigh him- or herself every day and the monitoring procedure happens as previously described. In addition a measurement of the blood pressure is also made.
干预措施: Home telemonitoring (Device)
结局指标
主要结局
Additional costs/savings resulting from the service
时间窗: 6 months
Defined as the difference in the costs of medical care during the study, identified through a cost analysis, between the intervention and control arms
Heart failure related hospital readmissions
时间窗: Intervention period (6 months)
Calculated as the proportion of patients readmitted to hospital at least once during the period of follow-up
次要结局
- Assessment of Quality of Life(At baseline and end of study (6 months))
- Length of stay(6 months)
研究者
Artur Serrano
Senior Research Scientist
University Hospital of North Norway