Development and Feasibility Testing of Digital Theory-based Pursed Lip Breathing in Stable Patients With COPD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Retention rate
研究概览
简要总结
The goal of this pre-post design clinical trial is to develop a digital, theory-based Pursed Lip Breathing intervention protocol software system installed on smartphones (DT-PLB) and to preliminarily evaluate its feasibility and effects in stable Chronic Obstructive Pulmonary Disease (COPD). The main objectives are:
- To develop a digital, theory-based Pursed Lip Breathing intervention protocol software system installed on smartphones for managing breathing exercises in stable COPD patients.
- To pilot the methodological procedures of the pre-post study.
- To determine the recruitment rate, retention rate, attrition rate, and software usage compliance during the subject recruitment and follow-up process of the pre-post study.
- To evaluate the perception and satisfaction of COPD patients using the DT-PLB.
- To preliminarily examine the effects of using the DT-PLB intervention on COPD patients, including the six-minute walking test, FEV1% predicted, FEV1/FVC, mMRC scale, COPD assessment test scale, and health points.
- To identify any potential adverse events associated with the implementation of DT-PLB.
Participants will perform the following tasks during the intervention:
- Register a personal account on the DT-PLB software.
- Acquire knowledge and skills related to Pursed Lip Breathing by watching instructional videos.
- Practice Pursed Lip Breathing for 10 minutes per session, three times daily for eight weeks, as per reminders and guidance provided by the software.
- Earn health points by completing specific actions as instructed.
- Optionally post individual texts on the peer forum for peer support within the DT-PLB software.
- Complete two outcome assessments as scheduled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with COPD satisfying GOLD criteria (Agusti, 2022) ;
- •Being Chinese;
- •Able to understand, speak, and hear;
- •Clinically stable for at least three months prior to enrollment (Soler-Cataluna et al., 2018) ;
- •The classification of GOLD grades for patients is mild, moderate, and severe, which means: FEV1/FVC<70%, FEV1>30%pre (Agusti, 2022) ;
- •Participants who were mindful about the IT technology and known how to use a smartphone.
排除标准
- •Impaired hand function causing inability to use the application;
- •Have disorders in pleural effusion, pulmonary malignancy, heart diseases, stroke with sequels;
- •Patients who have oral or nasal diseases cannot complete the exercise.
结局指标
主要结局
Retention rate
时间窗: From baseline (T1) to the completion of the 8-week intervention (T2)
The number of subjects who complete the study divided by the number of subjects who participate in the study
Attrition rate
时间窗: From baseline (T1) to the completion of the 8-week intervention (T2)
The number of subjects who drop out after participation divided by the number of subjects who participate in the study
Adverse events associated with the DT-PLB intervention
时间窗: Immediately after completion of the 8-week intervention
In each DT-PLB session, the participants during the intervention will record whether they had any uncomfortable feelings
Software usage Compliance
时间窗: Immediately after completion of the 8-week intervention
The compliance rate is one of compliance outcomes, reflecting the level of patient engagement in the intervention. Overall compliance will be defined as the compliance averaged in all patients. Compliance rate = (actual number of participation in the intervention/planned number of sessions)x 100%. In addition, minutes-consuming recorded on the software for participants during the research will be used to complement outcome measures of compliance.
Recruitment rate
时间窗: From baseline (T1) to the completion of the 8-week intervention (T2)
The number of participants who participate in the study divided by the number of participants eligible for participation
次要结局
- Participants overall satisfaction(Immediately after completion of the 8-week intervention (T2))
- Health points obtained by each participant performing formulated operations(Immediately after completion of the 8-week intervention)
- CAT scale(From baseline (T1) to the completion of the 8-week intervention (T2))
- mMRC Dyspnea Scale(From baseline (T1) to the completion of the 8-week intervention (T2))
- The System Usability Scale(Immediately after completion of the 8-week intervention (T2))
- Pulmonary function index:FEV1%predicted, FEV1/FVC(From baseline (T1) to the completion of the 8-week intervention (T2))
- Six-minute-walking test(From baseline (T1) to the completion of the 8-week intervention (T2))
研究者
Houqiang Huang
A postgraduate researcher in the School of Nursing & Public Health
Manchester Metropolitan University