HomeBase2: An Implementation Trial to Improve Access to Pulmonary Rehabilitation in People With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 490
- 试验地点
- 13
- 主要终点
- All cause, non-elective hospitalisation
研究概览
简要总结
People with chronic obstructive pulmonary disease (COPD) experience distressing breathlessness and high health care utilisation. There is compelling evidence that pulmonary rehabilitation improves symptoms and reduces hospitalisation, but is delivered to <10% of patients who would benefit. The investigators developed a low cost model of pulmonary rehabilitation that can be delivered entirely at home. The HomeBase model had equivalent outcomes to centre-based pulmonary rehabilitation in a phase II efficacy trial, with higher completion rates. The investigators hypothesise that a patient centred model offering a choice between home or centre-based pulmonary rehabilitation may increase program completion rates, with improved outcomes for patients and the health system.
This is a cluster randomised implementation trial investigating whether offering a choice of home or centre-based pulmonary rehabilitation can reduce hospitalisation, improve pulmonary rehabilitation completion and enhance patient outcomes in people with COPD. 14 pulmonary rehabilitation programs located across Australia will each recruit 35 people with COPD. Intervention centres: People with COPD will be offered the choice of centre-based pulmonary rehabilitation or the HomeBase model. Comparison centres: Only the existing centre-based model will be offered. The primary outcome is all cause, non-elective hospitalisation at 12 months. Other outcomes are symptoms, exercise capacity and quality of life at 8 weeks and 12 months; and health care costs at 12 months for full economic evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be informed that the trial is assessing the impact of pulmonary rehabilitation models on patient and health system outcomes, but not the specific nature of the models of interest, or the intervention group to which their site has been allocated.
Assessors will be blinded to the site allocation.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Attended pulmonary rehabilitation within 1 year
- •Comorbidities which preclude exercise training.
结局指标
主要结局
All cause, non-elective hospitalisation
时间窗: 12 months after completing pulmonary rehabilitation
The number of participants hospitalised at least once will be compared between groups
次要结局
- Change in 6-minute walk distance(End of rehabilitation and 12 months later)
- Program completion(End of rehabilitation)
- Change in chronic respiratory disease questionnaire total and domain scores(End of rehabilitation and 12 months later)
- EQ-5D-5L(End of rehabilitation and 12 months later)
- Change in objectively measured physical activity(End of rehabilitation and 12 months later)
- Health care costs(12 months following pulmonary rehabilitation completion)
- Change in dyspnoea-12(End of rehabilitation and 12 months later)
研究者
Anne E Holland PhD, FThorSoc
Professor of Physiotherapy
Monash University
