DRKS00032311招募中Unknown
Effects of app-based pulmonary rehabilitation teletherapy in combination with videotherapy following discharge of patients* after acute COPD exacerbation on their physical performance, quality of life, exacerbation and hospitalization rates: a randomized, controlled, exploratory study. - DIGI-PuRe
Breathment GmbH0 个研究点目标入组 44 人开始时间: 2023年9月28日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 40 Years 至 one(—)
- 性别
- All
入选标准
- •The target group is male and female COPD patients after exacerbation-related inpatient stay, >/= 40 years of all COPD stages and all health insurance companies with access to a smartphone and the competence to use an app.
- •Women of childbearing age must have a negative pregnancy test prior to entering the study
- •COPD patients who are willing and able to sign an informed consent form for the use of their pseudonymized clinical data in this intervention study
- •Diagnosis of COPD, defined as forced expiratory volume in 1s/forced vital capacity (FEV1/FVC) <70% predicted, FEV1 <80% predicted after bronchodilation, with or without chronic symptoms (cough, sputum production) corresponding to a GOLD stage II-IV.
- •Completion of the screening period and fulfillment of randomization criteria specified in the protocol
- •Ability to use a smartphone and smartphone apps
- •Knowledge of the German language to understand study materials, assessments, and therapy app content.
排除标准
- •Patient* is unable to complete the training program for physical, cognitive, or safety reasons as determined by the investigator, e.g., lower extremity joint surgery within the past three months, unstable cardiac disease, prevalent neurological limitations, planned surgical procedures, or other interventions that interfere with the study intervention.Lack of German language skills Lack of ability to use e-health technologies.Significant psychiatric disorders, immaturity, or impaired judgment. Participation in another clinical trial with an investigational drug within 30 days prior to study entry.
研究者
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