Development of a protocol to analyze the effects of digital healthcare on healthy life and disease prevention of COPD patients

Hanyang University0 个研究点目标入组 72 人开始时间: 待定最近更新: 2023年12月19日

适应症

试验速览

暂无简介。

•1. Adults 19 years of age or older
•2. If all of the following criteria are met among those in need of respiratory rehabilitation treatment due to respiratory symptoms or difficulties in daily life
•(1) Those with a modified Medical Research Council Dyspnea Scale (mMRC) of 1 or higher
•(2) In the case of one of the following (lung function in the last 1 year, chest CT at least once)
•? Those who are being treated for COPD
•? Post-bronchodilator FEV1/FVC less than 0.7
•? Those whose pulmonary diffusivity (DLCO) is less than 80% of the normal predicted value
•? Those with at least one of emphysema, air-trapping, and bronchial abnormalities on chest CT
•? Those with more than 1 of mMRC = 2, CAT = 10, acute exacerbation = 1 time/year
•(3) Those who have an Android smartphone (OS 8.0 or higher, internal memory (HDD) 32G or higher) or iPhone (iOS 13.0 or higher, internal memory (HDD) 32GB or higher)
•(4) Those who can effectively use smartphones/mobile software/wearable devices
•(5) A person who has no difficulty in carrying a smartphone while walking during the clinical trial period (12 weeks)
•(6) Those who voluntarily decided to participate in this clinical trial and agreed in writing to the subject's explanation and consent form
•(7) A person who is willing to comply with the clinical trial protocol

•1. Persons with respiratory muscle dysfunction such as neuromuscular disease, spinal cord injury, or respiratory failure due to thoracic deformity
•2. Those who have participated in respiratory rehabilitation within six months from the screening date
•3. A person who is unable to perform a gait test as of the screening date
•4. Persons with unstable cardiovascular disease (unstable angina pectoris, acute myocardial infarction, severe aortic stenosis, etc.)
•5. Those with uncontrolled pulmonary arterial hypertension
•6. Persons unable to participate in respiratory rehabilitation due to physical (e.g., lower extremity joint surgery performed within three months, neurological limitations) or cognitive reasons (e.g., severe mental illness, etc.)
•7. Pregnant or lactating women or women of childbearing potential who plan to become pregnant
•8. Those who cannot read or have limited communication skills
•9. Those who are currently participating in other clinical trials or have experience participating in other clinical trials within 90 days from the screening date
•10. In other cases, when the investigator judges that participation in the clinical trial is inappropriate because it may affect the clinical trial results or ethically
•11. Those who find it challenging to wear wearable devices continuously

发起方