Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital, North Zealand, Dyrehavevej 29, 3400, Hillerød, Denmark.
National Institute of Public Health, Copenhagen, Denmark.
Trials. 2023 Feb 6;24(1):86. doi: 10.1186/s13063-023-07099-1.
Individuals with severe chronic obstructive pulmonary disease (COPD) are often at risk of undernutrition with low health-related quality of life (HRQoL). Undernutrition can worsen COPD and other comorbidities, be an independent predictor of morbidity and functional decline resulting in increased healthcare consumption and increased risk of death. Especially exacerbations and acute infections result in unintentional weight loss. The aim is to investigate the effect of an individualized nutritional intervention among individuals with severe COPD.
An open-label randomized controlled trial with two parallel groups. Participants are recruited from the pulmonary outpatient clinic at the Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital, North Zealand, Denmark, and randomly allocated to either the intervention (intervention + standard of care) or control group (standard of care). The intervention has a duration of 3 months and combines individual nutritional care with adherence support and practical tools. It contains 4 elements including an individual nutritional plan, regular contacts, adherence support, and weight diary. The primary outcome is a difference in HRQoL (EQ-5D-5L) between the intervention and control group 3 months after baseline. Difference in functional capacity (grip strength, 30-s stand chair test, and physical activity), disease-specific quality of life (COPD Assessment Test), anxiety and depression (Hospital Anxiety and Depression Scale), nutritional parameters (energy and protein intake), anthropometry (weight, body mass index, waist, hip, and upper arm circumference), body composition (total fat-free and fat mass and indices), and prognosis (exacerbations, oxygen therapy, hospital contacts, and mortality) 3 months after baseline will be included as secondary outcomes. Data will be collected through home visits at baseline and 1 and 3 months after baseline.
Currently, nutritional care is a neglected area of outpatient care among individuals with severe COPD. If this patient-centered approach can demonstrate a positive impact on HRQoL, mortality, and hospital contacts, it should be recommended as part of end-of-life care for individuals with severe COPD.
ClinicalTrials.gov NCT04873856 . Registered on May 3, 2021.
患有严重慢性阻塞性肺疾病（COPD）的个体通常存在营养不良和健康相关生活质量（HRQoL）降低的风险。营养不良会加重 COPD 和其他合并症，是发病率和功能下降的独立预测因素，导致医疗保健消费增加和死亡风险增加。特别是加重和急性感染会导致非自愿性体重减轻。目的是研究个体化营养干预对严重 COPD 患者的影响。
一项开放标签随机对照试验，分为两组平行组。参与者从丹麦北西兰哥本哈根大学医院肺部门诊诊所招募，并随机分配到干预组（干预+标准护理）或对照组（标准护理）。干预持续 3 个月，将个体营养护理与依从性支持和实用工具相结合。它包含 4 个元素，包括个体营养计划、定期联系、依从性支持和体重日记。主要结局是干预组和对照组在基线后 3 个月时 HRQoL（EQ-5D-5L）的差异。功能能力（握力、30 秒站立椅测试和体力活动）、特定疾病的生活质量（COPD 评估测试）、焦虑和抑郁（医院焦虑和抑郁量表）、营养参数（能量和蛋白质摄入）、人体测量学（体重、体重指数、腰围、臀围和上臂围）、身体成分（总去脂和脂肪量及指数）以及预后（加重、氧疗、住院接触和死亡率）的差异也将作为次要结局。数据将通过基线和基线后 1 个月和 3 个月的家访收集。
目前，营养护理是严重 COPD 门诊护理中被忽视的领域。如果这种以患者为中心的方法能够对 HRQoL、死亡率和住院接触产生积极影响，它应该被推荐作为严重 COPD 患者临终关怀的一部分。
ClinicalTrials.gov NCT04873856。注册于 2021 年 5 月 3 日。
