Choyce Jocelyn, Shaw Karen L, Sitch Alice J, Mistry Hema, Whitehouse Joanna L, Nash Edward F
West Midlands Adult CF Centre, Heart of England NHS Foundation Trust, Bordesley Green East, Birmingham, B9 5SS, UK.
Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
BMC Pulm Med. 2017 Jan 23;17(1):22. doi: 10.1186/s12890-017-0366-x.
Home monitoring has the potential to detect early pulmonary exacerbations in people with cystic fibrosis (CF), with consequent improvements in health outcomes and healthcare associated costs. This study aims to assess the effects of home monitoring on hospital admissions, quality of life, antibiotic requirements, exacerbation frequency, lung function, nutritional outcomes, anxiety, depression, costs and health outcomes, as well as the qualitative effects on the patient experience.
This randomised controlled mixed-methods trial aims to recruit 100 adults with CF cared for in one large regional CF centre. Participants are randomly allocated 1:1 to the intervention group (twice-weekly home monitoring of symptoms measured by the Cystic Fibrosis Respiratory Symptom Diary - Chronic Respiratory Infection Symptom Score (CFRSD-CRISS) and Forced Expiratory Volume in one second (FEV)) or a control group (routine clinical care) for the 12-month study period. Measurements are recorded at study visits at baseline, 3, 6, 9 and 12 months. Spirometry, body weight, co-morbidities, medications, hospital inpatient days, courses of antibiotics (oral and intravenous), pulmonary exacerbations (defined by the modified Fuchs criteria) are recorded at each study visit. Health status, capability and health economics are measured at each study visit by the Hospital Anxiety and Depression Scale (HADS), the ICEpop CAPability measure for Adults (ICECAP-A), EuroQol 5 dimensions (EQ-5D-5L) questionnaire and an adapted resource use questionnaire. The patient experience is assessed by semi-structured qualitative interviews at baseline and 12 months.
Results from this study will help to determine the effect of home monitoring on inpatient bed days and quality of life in adults with CF, as well as other relevant health and health economic outcomes.
This study protocol is registered with Clinicaltrials.gov ( NCT02994706 ), date registered 16 July 2014.
家庭监测有潜力在囊性纤维化（CF）患者中检测出早期肺部恶化情况，从而改善健康结局并降低医疗相关成本。本研究旨在评估家庭监测对住院率、生活质量、抗生素需求、恶化频率、肺功能、营养状况、焦虑、抑郁、成本和健康结局的影响，以及对患者体验的定性影响。
这项随机对照混合方法试验旨在招募100名在一个大型地区CF中心接受治疗的成年CF患者。参与者按1:1随机分配至干预组（通过囊性纤维化呼吸症状日记 - 慢性呼吸道感染症状评分（CFRSD - CRISS）和一秒用力呼气量（FEV）每周两次在家监测症状）或对照组（常规临床护理），为期12个月的研究期。在基线、3、6、9和12个月的研究访视时记录测量数据。每次研究访视时记录肺功能测定、体重、合并症、药物、住院天数、抗生素疗程（口服和静脉）、肺部恶化情况（根据改良的富克斯标准定义）。每次研究访视时通过医院焦虑和抑郁量表（HADS）、成人ICECAP能力量表（ICECAP - A）、欧洲五维健康量表（EQ - 5D - 5L）问卷和一份改编的资源使用问卷来测量健康状况、能力和健康经济学。在基线和12个月时通过半结构化定性访谈评估患者体验。
本研究结果将有助于确定家庭监测对成年CF患者住院天数和生活质量的影响，以及其他相关的健康和健康经济学结局。
本研究方案已在Clinicaltrials.gov注册（NCT02994706），注册日期为2014年7月16日。
