Julius Center for Health Sciences and Primary care, University Medical Center Utrecht, PO box 85500, Stratenum 6,131, 3508, AB, Utrecht, the Netherlands.
BMC Public Health. 2012 May 28;12:385. doi: 10.1186/1471-2458-12-385.
Exercise reduced tolerance and breathlessness are common in the elderly and can result in substantial loss in functionality and health related quality of life. Heart failure (HF) and chronic obstructive pulmonary disease (COPD) are common underlying causes, but can be difficult to disentangle due to overlap in symptomatology. In addition, other potential causes such as obesity, anaemia, renal dysfunction and thyroid disorders may be involved.We aim to assess whether screening of frail elderly with reduced exercise tolerance leads to high detection rates of HF, COPD, or alternative diagnoses, and whether detection of these diseases would result in changes in patient management and increase in both functionality and quality of life.
METHODS/DESIGN: A cluster randomized diagnostic trial. Primary care practices are randomized to the diagnostic-treatment strategy (screening) or care as usual.
Frail (defined as having three or more chronic or vitality threatening diseases and/or receiving five or more drugs chronically during the last year) community-dwelling persons aged 65 years and older selected from the electronic medical files of the participating general practitioners. Those with reduced exercise tolerance or moderate to severe dyspnoea (≥2 score on the Medical Research Counsel dyspnoea scale) are included in the study.The diagnostic screening in the intervention group includes history taking, physical examination, electrocardiography, spirometry, blood tests, and echocardiography. Subsequently, participants with new diagnoses will be managed according to clinical guidelines. Participants in the control arm receive care as usual. All participants fill out health status and other relevant questionnaires at baseline and after 6 months of follow-up.
This study will generate information on the yield of screening for previously unrecognized HF, COPD and other chronic diseases in frail elderly with reduced exercise tolerance and/or exercise induced dyspnoea. The cluster randomized comparison will reveal whether this yield will result in subsequent improvements in functional health and/or health related quality of life.
ClinicalTrials.gov NCT01148719.
运动耐量降低和呼吸困难在老年人中很常见，会导致功能和健康相关生活质量的显著下降。心力衰竭（HF）和慢性阻塞性肺疾病（COPD）是常见的潜在病因，但由于症状学的重叠，很难将其区分开来。此外，肥胖、贫血、肾功能障碍和甲状腺疾病等其他潜在病因也可能涉及其中。我们旨在评估对运动耐量降低的虚弱老年人进行筛查是否会导致 HF、COPD 或其他诊断的高检出率，以及这些疾病的检出是否会导致患者管理的改变，从而提高功能和生活质量。
方法/设计：一项聚类随机诊断试验。初级保健机构被随机分配到诊断-治疗策略（筛查）或常规护理。
从参与的全科医生的电子病历中选择 65 岁及以上的虚弱（定义为患有三种或三种以上慢性或威胁生命的疾病，或在过去一年中慢性使用五种或五种以上药物）、社区居住的人群。那些运动耐量降低或中度至重度呼吸困难（呼吸困难量表上得分为≥2）的人将被纳入研究。干预组的诊断性筛查包括病史采集、体格检查、心电图、肺功能检查、血液检查和超声心动图。随后，将根据临床指南对新诊断的参与者进行管理。对照组的参与者接受常规护理。所有参与者在基线和 6 个月随访时填写健康状况和其他相关问卷。
这项研究将提供有关在运动耐量降低和/或运动诱发呼吸困难的虚弱老年人中筛查先前未被识别的 HF、COPD 和其他慢性疾病的效果的信息。聚类随机比较将揭示这种效果是否会导致随后的功能健康和/或健康相关生活质量的改善。
ClinicalTrials.gov NCT01148719。
