Nakken Nienke, Janssen Daisy J A, van den Bogaart Esther H A, Vercoulen Jan H, Wouters Emiel F M, Spruit Martijn A
Department of Research and Education, CIRO+, Centre of Expertise for Chronic Organ Failure, Horn, The Netherlands.
Department of Research and Education, CIRO+, Centre of Expertise for Chronic Organ Failure, Horn, The Netherlands Centre of expertise for palliative care, Maastricht University Medical Centre+ (MUMC+), Maastricht, The Netherlands.
BMJ Open. 2014 Nov 10;4(11):e006098. doi: 10.1136/bmjopen-2014-006098.
Chronic obstructive pulmonary disease (COPD) represents an important public health challenge. Patients are confronted with limitations during activities of daily living (ADLs). Resident loved ones of patients with COPD may be uniquely positioned to witness these limitations. COPD may have an impact on not only the patients' life, but also on the lives of the resident loved ones. Furthermore, COPD exacerbation-related hospital admissions often occur in patients with COPD. However, whether and to what extent these admissions influence resident loved ones' burden and health status remains currently unknown. Therefore, the primary objectives of this study are to investigate the differences between patients with COPD and resident loved ones' perceptions of patients' health status and problematic ADLs and to study prospectively the effects of a COPD exacerbation on resident loved ones' perceptions of patients' health status and problematic ADLs.
An observational, longitudinal study will be performed in 192 patients with COPD and their 192 resident loved ones. Primary outcomes are daily functioning, ADL, disease-specific health status, generic health status and dyspnoea. These will be assessed during home visits at baseline and after 12 months. Additional home visits will be performed when a COPD exacerbation-related hospital admission occurs during the 12-month follow-up period.
This protocol was approved by the Medical Ethics Committee of the Catharina Hospital Eindhoven, the Netherlands (NL42721.060.12/M12-1280) and is registered in the Dutch Trial Register (NTR3941).
慢性阻塞性肺疾病（COPD）是一项重大的公共卫生挑战。患者在日常生活活动（ADL）中面临诸多限制。慢性阻塞性肺疾病患者的常住亲人可能处于独特的位置，能够见证这些限制。慢性阻塞性肺疾病不仅可能影响患者的生活，还会影响常住亲人的生活。此外，慢性阻塞性肺疾病急性加重相关的住院情况在慢性阻塞性肺疾病患者中经常发生。然而，这些住院情况是否以及在多大程度上影响常住亲人的负担和健康状况，目前尚不清楚。因此，本研究的主要目的是调查慢性阻塞性肺疾病患者与常住亲人对患者健康状况和有问题的日常生活活动的认知差异，并前瞻性地研究慢性阻塞性肺疾病急性加重对常住亲人对患者健康状况和有问题的日常生活活动认知的影响。
将对192例慢性阻塞性肺疾病患者及其192名常住亲人进行一项观察性纵向研究。主要结局包括日常功能、日常生活活动、疾病特异性健康状况、一般健康状况和呼吸困难。将在基线时和12个月后进行家访时对这些指标进行评估。在12个月的随访期内，如果发生与慢性阻塞性肺疾病急性加重相关的住院情况，将进行额外的家访。
本方案已获得荷兰埃因霍温卡塔琳娜医院医学伦理委员会批准（NL42721.060.12/M12 - 1280），并已在荷兰试验注册中心注册（NTR3941）。
