Digital Therapy in Self-management of Chronic Obstructive Pulmonary Disease Patients：A Prospective, Open-labled, Multicenter Randomized Controlled Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- severe exacerbation
研究概览
简要总结
This project adopts a whole-process digital therapy intervention package composed of an inhalation technique assessment device, an electronic inhalant medication monitoring device and digital software to guide patients use the inhaler correctly personalizedly, record and manage the behavior data of chronic obstructive pulmonary disease (COPD) patients during the use of inhalant medication, and provide personalized reminders and feedback to patients according to the data. The purpose is to analyze whether this digital intervention scheme can reduce the number of acute exacerbations of COPD, improve the management effect of COPD, and reduce the burden of disease by improving the medication compliance of COPD patients.
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
- •Patients diagnosed with COPD
- •Aged 40 and above
- •Had one or more severe acute exacerbations in the past year, and be in stable condition for the last 4 weeks
- •Can operate a smartphone proficiently
- •Take inhalation medication suits for the inhalation monitoring device as treatment
- •Fully understand and be willing to sign the informed consent form
排除标准
- •Certain comorbidities (e.g. unstable coronary complications)
- •Undergone thoracic, abdominal or ophthalmic surgery in recent 3 months
- •Pregnant or lactating women
- •ABS allergy history
结局指标
主要结局
severe exacerbation
时间窗: 12 month
Proportion of patients with severe acute exacerbation of COPD pulmonary disease during the follow-up period.
次要结局
- First Second Forced Expiratory Volume/ Forced Vital Capacity(12 month)
- First Second Forced Expiratory Volume percentage of estimated(12 month)
- peak expiratory flow(12 month)
- COPD Assessment Test score(12 month)
- modified Medical Research Council scale(12 month)
- St. George's Respiratory Questionnairefor chronic obstructive pulmonary disease (SGRQ) score(12 month)
- peak inspiratory flow rate(12 month)
- mild and moderate exacerbation(12 month)
研究者
Hongtao Niu
PhD
China-Japan Friendship Hospital