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临床试验/NCT02618746
NCT02618746已完成不适用

Home Rehabilitation Via Telemonitoring of Vital Signs to Prevent Exacerbations in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Thorax Research Foundation0 个研究点目标入组 150 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
主要终点
Number of exacerbations

研究概览

简要总结

COPD is the fourth leading cause of death in the world and is the only one of the top five illnesses whose death rate is still increasing. It is mainly caused by smoking. Greece has a higher prevalence and death rate for COPD than many other countries in Europe. The disease is incurable so treatment is aimed at alleviating symptoms and slowing progression. Despite maximal medication and strategies such as pulmonary rehabilitation and home nurse support, many patients remain vulnerable, socially isolated and report difficulty in accessing their local health services. Research has shown that patients have worsening symptoms for an average of three to four days before they are admitted to hospital with an exacerbation of COPD. This suggests a window of opportunity to intervene. Early warning and contact via innovative technology may treat symptoms earlier, improve patient confidence / quality of life and simultaneously reduce health care visits or admissions. However, there is a large gap between the postulated and empirically demonstrated benefits of electronic Health Technologies. In addition, there is a lack of robust research on the risks of implementing these technologies and their cost-effectiveness has yet to be demonstrated, despite being frequently promoted by policymakers as if this was a given issue. In addition, the evidence-base for telehealth is not well-reported in peer reviewed journals and hence there continue to be difficulties experienced in convincing clinicians, hospital managers and stakeholders that investment in such technologies will enable reductions in other aspects of healthcare delivery over time.

This project attempts to provide robust justification of the effectiveness of telerehabilitation by the implementation of a randomized controlled trial blindly assigning COPD patients to: i) a home care and telerehabilitation group remotely monitored by a specialised private health care centre (Filoktitis - group A) or ii) a hospital-based rehabilitation group managed at a regular base through weekly visits by personnel at a state University rehabilitation centre (group B). iii) A third group that receives usual care (group C: control group; i.e.: neither home monitoring nor hospital based rehabilitation) is also included.

详细描述

COPD is an important health problem in Greece as the average prevalence of COPD in people > 35 years old is 8.4% (i.e.: approximately 350.000 citizens) (Tzanakis et al., 2004). Hospitalization attributed to severe exacerbations is the major cost driver of COPD. A study in Northern Greece revealed that mean actual cost per severe exacerbation of COPD is €1711, whilst only the amount of €621 is reimbursed by social security funds (Geitona et al., 2011). The observed price discrepancies between the actual and the nominal cost per patient, undoubtedly increases public debt especially when considering that patients with severe COPD suffer from acute exacerbations twice or three times per year.

Accordingly, there is urgent need to prevent exacerbations and subsequent hospitalizations in Greece. International evidence supports the concept that telemonitoring has a key role to play in systemic improvements to healthcare by reducing unplanned hospital admissions, hospital length of stay and the use of health care services, thereby making best use of scarce clinical resources and empowering individual patients. Home telemonitoring of chronic lung diseases appears as a promising patient management approach that could potentially produce accurate and reliable data, empower patients, influence their attitudes and behaviour, and improve patients medical conditions.

However, the scientific evidence in support of home telemonitoring is still weak and inconsistent, which highlights the need for more research, particularly in relation to the patient-level benefits, associated with these technologies. Furthermore, although, economic viability of telemonitoring has been observed in very few studies, in most cases no in-depth cost-minimization analyses were performed (Casas et al., 2006; Hernandez et al., 2015). Accordingly, there is a need of studies to accumulate evidence related to the interaction between the clinical effects of telemonitoring, its cost effectiveness, the impact on services utilization, and acceptance by health care providers. The project looks into the sustainability of patient telemonitoring services implemented by a private health care enterprise, namely the Filoktitis Rehabilitation Centre and its clinical effectiveness compared to a long term program of hospital-based rehabilitation (at Athens University 1st Department of Respiratory Medicine) not requiring home telemonitoring. The proposed strategy will allow the analysis and evaluation of reimbursement schemes and the design of appropriate business models.

The main idea is to initially (8-weeks) teach COPD patients techniques of self-management and improve their functional capacity by regular exercise training taking place at two different rehabilitation centres (one state hospital: Athens University Clinic of Respiratory Medicine, and one private hospital: Filoktitis Rehabilitation Centre) and subsequently either have the patients visiting the State University Hospital twice weekly for wellness and rehabilitation sessions and for regular checking of their clinical condition for 12 months or in the case of Filoktitis refer patients home to live independently whilst remotely monitoring the course of a number of vital signs that alert the physician when an exacerbation is eminent. (i.e., prematurely recognize symptoms of exacerbation). The initial 8-week sessions of rehabilitation takes place at both the University Hospital Clinic and at Filoktitis rehabilitation centre, whilst home monitoring will be implemented only to those who complete the initial 8-week phase at Filoktitis Rehabilitation Centre for a subsequent period of 12 months. Patients who complete the initial 8-week program at the University Clinic will keep visiting the centre twice weekly for 12 months. The ultimate objective of this project is to identify, in terms of health status outcomes, patient compliance and cost effectiveness, whether remote monitoring and management of patients by professionals at the private rehabilitation centre is superior to that not involving telemonitoring but regular visits to the University Hospital Clinic.

The aim of the proposed project in terms of specific patient outcome measures (namely annual rate of hospital admissions due to an exacerbation and exacerbations treated at home, emergency room visits, use of health care resources, quality of life, functional capacity and daily levels of physical activity) to test the efficacy of wireless systems for patient's home self-monitoring when this service is delivered remotely by a private rehabilitation centre compared to close monitoring of patients through regular visits to the University Hospital Clinic.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To be eligible for inclusion in this study Patients fulfil all of the following criteria:
  • Written informed consent obtained before any assessment is performed.
  • Male and female patients ≥ 40 years of age
  • Diagnosis of COPD [post-bronchodilator forced expiratory volume at one second (FEV1) <80% predicted and FEV1/ forced vital capacity (FVC) <75% without significant post-bronchodilator reversibility (<10% FEV1 % predicted normal)]
  • Optimal medical treatment according to GOLD without regular use of systemic corticosteroids
  • Current or ex-smokers with a smoking history equivalent to at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year)
  • Absence of other significant diseases that could contribute to exercise limitation
  • At least 2 COPD exacerbations the year before the time entry

排除标准

  • Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No additional exclusions are applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.
  • Orthopedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator. Specifically if the patients' condition/ co-morbidities are such that physical activity cannot be increased.
  • Respiratory diseases other than COPD (e.g. asthma)
  • Cognitive reading impairment and/or difficulties to manage electronic devices precluding interaction with the tablet, as judged by the investigator
  • Patients not on optimal pharmacotherapy
  • No COPD exacerbations the year before the time entry

结局指标

主要结局

Number of exacerbations

时间窗: 12 months

Unscheduled hospital admissions due to an exacerbation including exacerbations treated at home

次要结局

  • Functional Capacity(12 months)
  • Number of visits to Emergency Outpatient Clinic(12 months)
  • Daily physical activity levels(12 months)
  • Quality of life and symptoms(12 months)

研究者

发起方
Thorax Research Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

IOANNIS VOGIATZIS

Associate Professor

National and Kapodistrian University of Athens

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