Nyberg André, Wadell Karin, Lindgren Helena, Tistad Malin
Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.
Department of Computing Science, Umeå University, Umeå, Sweden.
BMJ Open. 2017 Aug 1;7(7):e016851. doi: 10.1136/bmjopen-2017-016851.
INTRODUCTION: The use of adequate self-management strategies for people with chronic obstructive pulmonary disease (COPD) reduces healthcare use, improves health-related quality of life (HRQoL) and recovery after acute exacerbations. However, not many people with COPD receive support that promotes the use of such strategies and therefore new methods to facilitate and promote the use of self-management strategies are highly warranted. This pilot trial aims to evaluate the feasibility of the study design and study procedures considering effectiveness of the novel intervention, METHODS AND ANALYSIS: The overall design is a pragmatic controlled pilot trial with preassessments and postassessments and a parallel process evaluation. Patients with the diagnosis of COPD will be eligible for the study. The intervention group will be recruited when visiting one of the six participating primary care units in Sweden. The control group will be identified from the unit's computerised registers. The intervention, the COPD-web, is an interactive web page with two sections; one directed at people with COPD and one at healthcare professionals. The sections aim to support patients' self-management skills-and to facilitate the provision of support for self-management strategies, respectively. Effectiveness with regard to patients' symptoms, HRQoL, knowledge of and readiness for COPD-related self-management, health literacy, self-efficacy for physical activity and time spent in physical activity and time being sedentary, and further, healthcare professionals' knowledge of and readiness to support COPD-related self-management strategies will be assessed using questionnaires at 3 and 12 months. The process evaluation will include observations and interviews. ETHICS AND DISSEMINATION: Ethical approval has been obtained. Findings will be presented at conferences, submitted for publication in peer-reviewed publications and presented to the involved healthcare professionals, patients and to patient organisations. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT02696187.
引言：慢性阻塞性肺疾病（COPD）患者采用适当的自我管理策略可减少医疗保健的使用，提高健康相关生活质量（HRQoL）并促进急性加重后的恢复。然而，没有多少COPD患者获得促进此类策略使用的支持，因此，非常有必要采用新方法来促进和推动自我管理策略的使用。这项试点试验旨在评估考虑到新型干预措施有效性的研究设计和研究程序的可行性。 方法与分析：总体设计是一项实用的对照试点试验，包括预评估和后评估以及并行的过程评估。诊断为COPD的患者将符合该研究的条件。干预组将在访问瑞典六个参与的初级保健单位之一时招募。对照组将从该单位的计算机登记册中确定。干预措施COPD-web是一个交互式网页，有两个部分；一部分针对COPD患者，另一部分针对医疗保健专业人员。这些部分旨在分别支持患者的自我管理技能，并促进为自我管理策略提供支持。将在3个月和12个月时使用问卷评估患者症状、HRQoL、COPD相关自我管理的知识和准备情况、健康素养、身体活动的自我效能以及身体活动时间和久坐时间方面的有效性，此外，还将评估医疗保健专业人员对COPD相关自我管理策略的知识和支持准备情况。过程评估将包括观察和访谈。 伦理与传播：已获得伦理批准。研究结果将在会议上展示，提交给同行评审出版物发表，并向相关医疗保健专业人员、患者和患者组织展示。 试验注册号：ClinicalTrials.gov：NCT02696187。
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