Feasibility and Effect of a Follow up Tele-rehabilitation Program for Chronic Obstructive Lung Disease vs. Standard Follow up
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- 6 minute walk test
研究概览
简要总结
Introduction In order to guarantee chronic patients & elderly a high quality service from health care organizations in the coming decades, new technologies have been implemented to treat patients from a distance. There is still a need for more studies on the efficacy and cost-effectiveness of tele-rehabilitation (TR) and its long-term effects needs also to be determined. To guarantee individuals with chronic obstructive pulmonary diseases (COPD) a high quality service from health care organizations in the coming decades and economically save the national health systems for an expensive bill for the treatment of COPD, new actions plans has to be taken into use. Hereby, more patients can be treated with less human resources while still sustaining or even improving today's services. The importance of such welfare action plans has to maintain a high quality of service that individuals with COPD are willing to accept. Here, TR seems to be a good welfare action plans. Despite proof of improved cost-effectiveness, no studies support the benefits of TR in COPD patient with respect to adherence, security, treatment efficacy and improved quality of life.
Aim To assess and compare the feasibility and effect of a tele-rehabilitation program with a new and innovative TR platform (NITRP) compared to standard treatment with respect to exercise capacity, quality of life and activities of daily living in patients with COPD.
Method and material The study is a prospective randomized controlled trial comparing the effects of a follow-up tele-rehabilitation program and conventional follow-up rehabilitation in patients with severe COPD. 54 patients fulfilling the inclusion criteria will be randomized in two groups to either an 8 week follow-up tele-rehabilitation program or to standard follow up after rehabilitation. Participants will be tested at baseline, after 8 weeks and 6 months after cessation of the training programs. In the intervention group, a real- and a virtual physiotherapist agent will facilitate the rehabilitation.
Ethical considerations This study will not pose any risk to the patient as compared to current practice. Participation is voluntary and the patient may at any time withdraw from the study without consequences for future care or treatment. The questionnaires and the test methods used are clinically recognized instruments. Signed informed consent will be obtained from the all participants after verbal and written information and before the study starts. The study will not be initiated before approval from the Ethics Committee and the Data Protection Agency has been obtained. The study will follow the general research ethical rules as expressed in the Helsinki Declaration II.
详细描述
Intro
To guarantee chronic patients and elderly a high quality service from health care organizations in the coming decades, new technologies has been implemented to treat patients from a distance. This document reflects the latest research studies based on tele-rehabilitation (TR), its application in chronic lung diseases and the topics that still needs to be investigated.
TR Studies of TR in patients with lymphedema (Galiano-Castillo et al., 2014) or COPD (Paneroni et al., 2014)(Tousignant et al., 2012)(Dinesen, Seeman, and Gustafsson, 2011)(Dinesen, Huniche, and Toft, 2013) or in the orthopedic areas as, lower back (Palacín-Marín et al., 2013), knee (Cabana et al., 2010) (Tousignant, Moffet, et al., 2011) (Tousignant, Boissy, et al., 2011) and shoulder (Eriksson et al., 2009)(Eriksson, Lindström and Ekenberg, 2011) show that tele-technology has been developed to a level where it is possible to treat, test and follow-up patients from a distance. Patients who have not been offered such solutions face increased risks of hospital-acquired infections (Dancer, 2009) and longer travel and waiting time to get treated. The public sector expects higher expenditure due to treatment and transportation cost, specifically in chronic patients and the elderly whose numbers tends to increase according to demographics trend (Palacín-Marín et al., 2013)(Barros et al., 2011)(Parker and Thorslund, 2007)(Yach, Hawkes, Gould, and Hofman, 2004). Such facts points to the need of creating and improving solution that overcome such health care challenges.
TR seems to be a good approach to reach patients in low inhabited areas (Hill and Sppath, 2010), changing health care to self-care (Haarder, 2011), empowering patient's awareness on their disease and increasing the flexibility patients need to acquire to obtain healthier behaviors. Although the interest in TR research is high, there is still a need for more studies on the efficacy (Paneroni et al., 2014) and cost-effectiveness of TR (Paneroni et al., 2014) (Langberg, Lindahl, Kidholm, and Dinesen, 2014) just as the long-term effects of TR have to be determined (Langberg et al., 2014).
Chronic obstructive pulmonary disease (COPD) COPD is among the most resource costly diseases we face in our century (Kjøller, Juel and Kamper-Jørgensen, 2007). In Denmark, approximately 430,000 people have COPD of which around 50,000 have severe COPD (Kirkegaard N, Brandt A, Timm H, 2013)(Mannino, Doherty and Sonia Buist, 2006). Eriksen (Eriksen and Vestbo, 2010) states that up to 42.3% of patients with COPD discharged from hospitals are readmitted the following year, and 17% of patients treated in emergency departments require hospitalization. Danish pulmonary physicians concluded that COPD cost the Danish society three billion DKK in 2002 (Hos, 2007) where up to 20% of the most severe COPD patients consume over 70% of the total health expenditure (Jansson et al., 2002). Nowadays, some municipalities have already problems with offering rehabilitation services to all COPD patients in some areas in Denmark (Kjøller, Juel and Kamper-Jørgensen, 2007). Actions implementing TR for COPD patients have been started and research begins to show some improvements.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable COPD
- •Signed informed consent
- •Completion of the standard rehabilitation program
- •Permanent oxygen therapy is not an obstacle for participation.
排除标准
- •The patient has significant musculoskeletal disorders that limit his / her function levels to a degree that is not caused by dyspnea
- •The patient has pronounced dizziness, significant sensory or motor disability, dementia or terminal malignant disease
- •Serious comorbidities (unstable heart disease, irregular diabetes, known malignant disease, another disease that makes the patient unfit to participate in the study).
- •Non-compliant patient (eg. Nursing Homes Residents)
- •Participation in another project within the last 30 days
- •Mini-Mental State Examination score less than 24 points
- •Severe vision or hearing loss.
- •Non-Danish speaking.
- •Lack of will to implement the protocol.
- •Motor or sensory disease, which makes it impossible for walk training
- •Have experienced a worsening in the last 4-6 weeks
- •Musculoskeletal disorders
- •Serious heart diseases (ejection fraction <30%, daily angina, or as indicated by treating the cardiologist)
- •Can not understand informed consent
- •Other factors that inhibit the use of telerehabilitation
研究组 & 干预措施
Control group
There is no conventional rehabilitation follow up program, but all patients are encouraged to continue training
Intervention group
The intervention group will obtain telerehabilitation
干预措施: Tele rehab (Behavioral)
结局指标
主要结局
6 minute walk test
时间窗: measured at week 8
Change in the 6 minute walk test
次要结局
- 6 minute walk test(6 months after cessation)
- Health-related quality of life(8 weeks, and 6 months after cessation)
- Generalised Anxiety Disorder Assessment (GAD-7)(8 weeks, and 6 months after cessation)
- health-related quality of life measured by SGRQ(6 months after cessation)
- Cost tele-rehab(6 months)
