Proof of Concept (Proof of Intervention Principles) Study Assessing Effects of Technology-Assisted Respiratory Adherence Prototype Version 3 (a Digital Behaviour Change Intervention, DBCI) on Proximal Clinical Outcomes and Mediators (Psychological Mediators, Self-management Behaviours) in Individuals With COPD (IwCOPD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Number of Subjects With Increase From Baseline in the CRQ-SAI Dyspnea Domain Score at 12 Weeks of at Least 0.5
研究概览
简要总结
The study's primary aim is to assess whether there is a clinically significant reduction in breathlessness in symptomatic individuals with chronic obstructive respiratory disease (IwCOPD) following engagement with Technology-Assisted Respiratory Adherence prototype 3.
The study's secondary aim is to assess whether there is an associated maintenance or increase in activities of daily living to support a positive benefit of Technology-Assisted Respiratory Adherence prototype 3 on breathlessness and whether there is an improvement in the physical activity experience of the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Subjects With Increase From Baseline in the CRQ-SAI Dyspnea Domain Score at 12 Weeks of at Least 0.5
时间窗: Baseline (week 0) and Week 12.
Number of subjects with increase from baseline in the CRQ-SAI dyspnea domain score at 12 weeks of at least 0.5, the minimal clinically important difference (MCID). The CRQ-SAI questionnaire first asks participants to mark important, frequent activities that made them feel out of breath during the last 2 weeks. Participants are then asked to select the most important activities from the list, up to a maximum of 5 activities. Next, for each of these activities, which correspond to questions 1-5, the participants will mark their level of shortness of breath; there are 7 possible answers, ranging from 1 (being the worst: "extremely short of breath') to 7 (being the best: "not at all short of breath"). For each participant, the CRQ-SAI dyspnea domain score was calculated as the mean of numerical answers to the questions 1, 2, 3, 4, 5, excluding those questions not answered. Change was calculated as \[score at 12 weeks\] - \[score at baseline\].
Change From Baseline in the Chronic Respiratory - Self Administered Individualized (CRQ-SAI) Dyspnea Domain Score at 12 Weeks
时间窗: Baseline (week 0) and Week 12.
The CRQ-SAI questionnaire first asks participants to mark important, frequent activities that made them feel out of breath during the last 2 weeks; they can select these activities from a list, and they can also add additional activities to the list. Participants are then asked to select the most important activities from the list, up to a maximum of 5 activities. Next, for each of these activities, which correspond to questions 1-5, the participants will mark their level of shortness of breath; there are 7 possible answers, ranging from 1 (being the worst: "extremely short of breath') to 7 (being the best: "not at all short of breath"). For each participant, the CRQ-SAI dyspnea domain score was calculated as the mean of numerical answers to the questions 1, 2, 3, 4, 5, excluding those questions not answered. Change was calculated as \[score at 12 weeks\] - \[score at baseline\].
次要结局
- Change From Baseline in the Difficulty Domain of the Clinical Visits PROactive Physical Activity in COPD Instrument (C-PPAC) at Week 12(Baseline (week 0) and Week 12.)
- Change From Baseline in Average Number of Steps Measured by the Activity Tracker at Week 12(Baseline (week 0) and Week 12.)
- Change From Baseline in Average Cadence (Steps/Min) Measured by the Activity Tracker at Week 12(Baseline (week 0) and Week 12.)