Feasibility & Effect of a Tele-rehabilitation Program for Chronic Obstructive Pulmonary Disease vs. Standard Rehabilitation
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- 6 Minutes Walk Test
研究概览
简要总结
Introduction In order to guarantee chronic patients and 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 tele-rehabilitation and conventional rehabilitation in patients with severe COPD. 54 patients fulfilling the inclusion criteria will be randomized in two groups to either a 8 week tele-rehabilitation program or a conventional COPD rehabilitation program at the hospital. Participants will be tested at baseline, 8 weeks, 3 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
Introduction
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.
Tele-rehabilitation 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, Esteban-Moreno, Olea, Herrera-Viedma, & Arroyo-Morales, 2013), knee (Cabana et al., 2010) (Tousignant, Moffet, et al., 2011) (Tousignant, Boissy, et al., 2011) and shoulder (Eriksson, Lindström, Gard, & Lysholm, 2009)(Eriksson, Lindström, & 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, Francisco, Zanchetta, & César, 2011)(Parker & Thorslund, 2007)(Yach, Hawkes, Gould, and Hofman, 2004). Such facts points to the need of creating and improving solutions 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 of 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 et al., 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
- •A diagnosis of COPD (FEV1/FVC < 70% in a stable phase of the disease)
- •Age > 18 years
- •Referred for conventional COPD rehabilitation
- •Compliant patient willing to fulfill the study requirements
- •Signed informed consent (Oxygen therapy is not an obstacle for participation).
排除标准
- •Musculoskeletal disorders limiting training
- •Dizziness, significant sensory or motor disabilities, dementia or terminal malignant disease precluding training
- •Severe comorbidities such as i.e. unstable heart disease, dysregulated diabetes, known malignant disease, any other illness making the patient inappropriate for participating in the study
- •Non-compliant patient
- •Severe vision or hearing impairment
- •Non-Danish speaking
- •Unwillingness or inability to follow the protocol
- •COPD exacerbation in the preceding 6 weeks
研究组 & 干预措施
Intervention group "tele-rehabilitation"
Video Consultation (VC) Sessions: Each patient will have the opportunity to have minimum one VC per week the first month, one VC each second week the second month one VC a month Retraining breath: Patients will also be instructed to use different techniques to breath during the video consultations with the physiotherapist. Chat Sessions: Each patient has the opportunity to chat with the physiotherapist any time via the chat module of the system. Workout Sessions with a Virtual Physiotherapist Agent (VPA):
The patient will train according to what is decided by the physiotherapist and the patient in the VC or chat meetings. Normally, the patients will train 10-20 minutes daily at home with its individual and tailored VPA. Patients' security: In order to minimize the risks of possible accidents while performing the exercises, the patient will answer questions before and after each exercise performance that the physiotherapist can follow in real time.
干预措施: Tele Rehab (Combination Product)
Control
COPD patients in the control group will undergo the conventional standardized rehabilitation program as implemented at the Department of Respiratory Medicine and Allergy, Aarhus University Hospital. The program is an 8 weeks program consisting of 2 weekly group training sessions at the hospital with instruction by a physiotherapists and 6 hours of education about COPD and its treatment.
干预措施: Tele Rehab (Combination Product)
结局指标
主要结局
6 Minutes Walk Test
时间窗: 9 weeks
Change in the 6MWT measured at week 9
次要结局
- 6 Minutes Walk Test(3 and 6 months after cessation of the tele-rehabilitation program)
- Health-related quality of life SGRQ (in total score)(at week 9, and 3 and 6 months after cessation of the tele-rehabilitation program)
- Health-related quality of life GAD-7(at week 9, and 3 and 6 months after cessation of the tele-rehabilitation program)
- Health-related quality of life SGRQ (symptoms, activity & impact)(at week 9, and 3 and 6 months after cessation of the tele-rehabilitation program)
- Cost of the tele-rehabilitation program(at week 9)
