Adaptive Computerized COPD Exacerbation Self-management Support (ACCESS): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Number of exacerbation-free weeks
研究概览
简要总结
Aim is to test the effect of ACCESS ("Adaptive Computerized COPD Exacerbation Self-management Support"), a software application designed to support patients with COPD in self-management of exacerbations.
详细描述
Rationale: COPD exacerbations considerably affect patients' health status and contribute to COPD related costs. Patients often have problems in recognizing and responding promptly to exacerbations. Tools that support patients in exacerbation self-management such as paper exacerbation action plans and telemonitoring systems have shown some positive results on exacerbation related outcomes. However, many patients appear not to adhere to their action plan instructions. Besides, existing telemonitoring tools rely heavily on the input of healthcare professionals which makes it difficult to assess the true effects and cost effectiveness of telemonitoring systems.
Recently, the Radboud University has developed the "Adaptive Computerized COPD Exacerbation Self-management Support" (ACCESS) system. This software application integrates objective parameters, such as spirometry, pulse-oximetry, temperature, and self-reported symptom worsening into a Bayesian network model resulting in a weighted exacerbation risk prediction. Patients are able to monitor themselves at any given moment. The ACCESS system not only predicts whether an exacerbation is imminent, but also provides ad hoc tailored advice without interference of a healthcare professional.
Objective: In this project the primary aim is to assess the (cost-)effectiveness of the ACCESS system in the support of exacerbation self-management in patients with COPD.
Study design: A multicenter, pragmatic, two-arm, randomized controlled trial with a follow-up of 12 months per participant.
Study population: Patients with COPD, > 40 years old, with 2 or more self-reported symptom based exacerbations in the previous year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed diagnosis of COPD by spirometry (post-bronchodilator FEV1/FVC < 0.70);
- •at least 2 self-reported exacerbations in the previous 12 months, i.e. a change for ≥ 2 consecutive days in either ≥ 2 major symptoms (dyspnea, sputum purulence, sputum amount) or any 1 major symptom plus any ≥ 1 minor symptoms (colds, wheeze, sore throat, cough).
排除标准
- •severe co-morbid conditions that prohibit participation;
- •unable to communicate in the Dutch language;
- •difficulties using a smartphone;
研究组 & 干预措施
ACCESS
ACCESS is used when participants experience more COPD symptoms.
干预措施: ACCESS (Device)
paper plan
Paper exacerbation action plan is used when participants experience more COPD symptoms.
结局指标
主要结局
Number of exacerbation-free weeks
时间窗: 1 year
Measured with the Telephonic EXacerbation Assessment System (TEXAS) \[Bischoff, ERJ, 2012\]
次要结局
- Improvement in Quality of Life(1 year)
- Improvement in exacerbation-related self-management behaviour(1 year)
- Improvement in self-efficacy(1 year)
- Number of ER visits and hospital admissions(1 year)
- Cost-effectiveness of ACCESS; ratio calculated with the use of medical records and questionnaires.(1 year)