Wright Caroline, Hart Simon P, Allgar Victoria, English Anne, Swan Flavia, Dyson Judith, Richardson Gerry, Twiddy Maureen, Cohen Judith, Hussain Jamilla, Johnson Miriam, Hargreaves Ian, Crooks Michael G
Respiratory Research Group, Hull York Medical School, Cottingham, UK.
Health Sciences, University of York, York, UK.
ERJ Open Res. 2019 Oct 21;5(4). doi: 10.1183/23120541.00186-2019. eCollection 2019 Oct.
Idiopathic pulmonary fibrosis (IPF) is a chronic and progressive lung disease that causes breathlessness and cough that worsen over time, limiting daily activities and negatively impacting quality of life. Although treatments are now available that slow the rate of lung function decline, trials of these treatments have failed to show improvement in symptoms or quality of life. There is an immediate unmet need for evidenced-based interventions that improve patients' symptom burden and make a difference to everyday living. This study aims to assess the feasibility of conducting a definitive randomised controlled trial of a holistic, complex breathlessness intervention in people with IPF.
The trial is a two-centre, randomised controlled feasibility trial of a complex breathlessness intervention compared with usual care in patients with IPF. 50 participants will be recruited from secondary care IPF clinics and randomised 1:1 to either start the intervention within 1 week of randomisation (fast-track group) or to receive usual care for 8 weeks before receiving the intervention (wait-list group). Participants will remain in the study for a total of 16 weeks. Outcome measures will be feasibility outcomes, including recruitment, retention, acceptability and fidelity of the intervention. Clinical outcomes will be measured to inform outcome selection and sample size calculation for a definitive trial.
Yorkshire and The Humber - Bradford Leeds Research Ethics Committee approved the study protocol (REC 18/YH/0147). Results of the main trial and all secondary end-points will be submitted for publication in a peer-reviewed journal.
特发性肺纤维化（IPF）是一种慢性进行性肺部疾病，可导致呼吸急促和咳嗽，且随着时间推移会逐渐加重，限制日常活动并对生活质量产生负面影响。尽管目前已有治疗方法可减缓肺功能下降速度，但这些治疗方法的试验未能显示出症状或生活质量的改善。当下迫切需要有循证依据的干预措施来减轻患者的症状负担并改善日常生活。本研究旨在评估对IPF患者进行一项全面、复杂的呼吸急促干预的确定性随机对照试验的可行性。
该试验是一项两中心的随机对照可行性试验，将一种复杂的呼吸急促干预措施与IPF患者的常规护理进行比较。将从二级护理IPF诊所招募50名参与者，并按1:1随机分组，一组在随机分组后1周内开始干预（快速通道组），另一组在接受干预前先接受8周的常规护理（等待名单组）。参与者将总共参与研究16周。结局指标将是可行性指标，包括招募、留存、干预措施的可接受性和保真度。还将测量临床结局，为确定性试验的结局选择和样本量计算提供信息。
约克郡和亨伯 - 布拉德福德利兹研究伦理委员会批准了研究方案（REC 18/YH/0147）。主要试验结果和所有次要终点结果将提交至同行评审期刊发表。
