Implementation of Telemonitoring in the Management of Acute Exacerbations of Chronic Heart Failure and Respiratory Failure/Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 3
- 主要终点
- Time to first event
研究概览
简要总结
The aims of the study are to:
- Implement a telemonitoring programme in heart failure and obstructive pulmonary disease (COPD) /chronic respiratory patients by assessing the real world impact of on readmissions, consults, home visits, quality of life and economic endpoints.
- Explore the effects of telemonitoring across heart and respiratory groups with respect to i) factors that influence how patients integrate telemonitoring into their daily routines and self care behaviour and ii) how healthcare professionals use telemonitoring to aid decision- making.
- Understand the impact of telemonitoring on a variety of care pathways.
详细描述
BACKGROUND
Heart failure exacerbations consume 60-70% of costs for the condition and COPD exacerbations lead to 1:8 admissions so are costly to the NHS. The roll-out of telemonitoring in chronic disease is in line with NHS policy (Building Telecare in England; High Quality Care for All, national health service (NHS) next stage Darzi review).
Despite systematic reviews, the Whole System Demonstrator programme and randomised control trial (RCT) evidence in heart failure, the outcome of implementing telemonitoring is unclear, the evidence base in COPD is less consistent, and few studies have included economic analysis or investigated cross speciality implementation. An Italian trial found that telemedicine reduces chronic respiratory admissions by a third, but the Italian health service differs from the united kingdom (UK) system. The european union (EU) Commission Communication on telemedicine 2009 has stressed the need for new deployments to contribute to the evidence base in respiratory disease, and include a detailed analysis of the process changes that determine success. Our group has previously shown that telemonitoring reduces unplanned admissions in heart failure patients, and that elderly patients were able to cope well with the equipment. The investigators have also had experience with telesupport in chronic respiratory patients.
RATIONALE FOR CURRENT STUDY
The study will assess the implementation of a telemonitoring programme to demonstrate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart failure patients: age > 18 years who were in New York Heart Association class II-IV at time of discharge diagnosed by ESC guidelines.
- •Respiratory patients: age > 18 years with diagnosis of COPD or respiratory insufficiency due to chronic respiratory disorder diagnosed by Consultant Respiratory Physician (eg. bronchiectasis, chest wall disease, neuromuscular disorder) and arterial oxygen saturation value during most recent admission for exacerbation of 90% or below (or partial pressure of oxygen in arterial blood (PaO2) 8.0 kilopascal (kPa) or below) on air, or who fulfill criteria for, and receive long term oxygen therapy.
排除标准
- •Age <18 years.
- •Cognitive impairment sufficient to interfere with use of telemonitoring system.
结局指标
主要结局
Time to first event
时间窗: at 6 months
Acute admission coded as due to acute exacerbation of heart failure/COPD, respiratory failure or mortality from heart failure/respiratory failure/COPD.
次要结局
- Focus interviews(6 and 12 months after completion of the study)
- Health care contacts(0,1,2,3,4,5,6,7,8,9,10,11 and 12 months)
- Hospital Anxiety and Depression Score (HADS)(0, 3, 6, 9 and 12 months)
- Compliance with telemonitoring(averaged over the expected 6 month period)
- Chronic Respiratory Disease Questionnaire (CRQ)(0, 3, 6, 9 and 12 months)
- Self Efficacy(0, 3, 6, 9 and 12 months)
- Minnesota Living with Heart Failure questionnaire(0, 3, 6, 9 and 12 months)
- The EuroQOL five dimensions questionnaire (EQ 5D)(0, 3, 6, 9 and 12 months)