Implementation of Evidence-based Breathing Retraining for Patients With Asthma in Region Zealand, Denmark
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Adoption of intervention (Uptake)
研究概览
简要总结
This study aims to implement the evidence-based intervention breathing retraining into clinical care of patients with symptomatic asthma irrespective of asthma severity or comorbidities, and in a diverse multicentre setting to evaluate implementation outcomes. This will meet patients' needs and improve health and life situation in patients with uncontrolled asthma. Further, the study will evaluate implementation outcomes.
详细描述
This study is a hybrid-designed prospective multicenter implementation evaluation study, in which the investigators secondarily will maintain measuring effectiveness of breathing retraining in a real-world setting including primary and secondary health care and add cross-sectorial co-operation. Thus, investigators include more primary outcomes.
The study is part of Exercise First-project, a collaboration of The National Health Service, Region Zealand and the research unit PROgrez, Department of Physiotherapy and Occupational Therapy at Næstved, Slagelse, Ringsted hospitals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Doctor diagnosed asthma;
- •Incompletely controlled asthma or worse: Asthma Control Questionnaire (ACQ5) score ≥0.8;
- •Residence (or asthma treatment program) in Region Zealand, Denmark;
- •Able to read and understand Danish or available assistance to help understand information material, intervention content and respond to questionnaires.
排除标准
- •Unwilling to participate;
- •Unable to participate in the intervention due to physical or mental condition.
研究组 & 干预措施
Breathing Retraining (BR)
Patients will receive three sessions (60 min, 30 min, 30 min) of breathing retraining (BR), 1-to-1 with a trained physiotherapist.
As preferred by the patient:
- Hybrid delivery mode of BR (H-BR): First session on-site at hospital/clinic for initial assessment and introduction, and following sessions online (MedComs VDX platform or equal; participants access using web cam and sound on smart phone, tablet, or pc).
- Ordinary delivery of BR: Three sessions on-site at hospital/clinic.
干预措施: Breathing Retraining (Other)
结局指标
主要结局
Adoption of intervention (Uptake)
时间窗: Through study completion, an average of 1 year
Organization-related (Pulmonologists, general practioners, physiotherapists) outcome: Proportion of general practices and of hospitals that will adopt BR.
Implementation of intervention (Fidelity)
时间窗: Through study completion, an average of 1 year
Organization-related (physiotherapists) outcome: % of contents delivered as planned assessed by a checklist of key aspects in the breathing retraining-intervention.
Feasibility of online sessions in Hybrid delivery mode of BR (H-BR) (Acceptability)
时间窗: Through study completion, an average of 1 year
Patient- and Organization-related (physiotherapists) outcome: assessed by a semi-structured interview.
Effectiveness: MiniAsthma Quality of Life Questionnaire, MiniAQLQ
时间窗: Through study completion, an average of 1 year
Patient-related outcome, disease specific quality of life questionnaire. 7-point Likert scales from 1-7, 1 = worse outcome, 7 = better outcome. Success rates of improvements minus deteriorations of individual effects, measured at 12 month follow up.
次要结局
- Objective steps per day (average)(Change from baseline to 12 month)
- MiniAsthma Quality of Life Questionnaire, MiniAQLQ(Change from baseline to 12 months)
- Objective physical activity level(Change from baseline to 12 month)
- Breathing pattern observation(Change from baseline to 12 month)