Benefits and Costs of Home-based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 4
- 主要终点
- Change in 6-minute walk test
研究概览
简要总结
Pulmonary rehabilitation is an effective treatment for people with chronic obstructive pulmonary disease (COPD) which improves symptoms, reduces hospitalisation and lowers healthcare costs. However less than 1% of Australians with COPD receive pulmonary rehabilitation each year, due to poor access to programs and high levels of disability. This randomised controlled trial will examine the benefits and costs of a novel, entirely home-based pulmonary rehabilitation program for COPD. We hypothesise that home-based pulmonary rehabilitation can deliver equivalent clinical outcomes at lower cost than the centre-based program.
We will randomly allocate 144 people with COPD to undertake either standard pulmonary rehabilitation in a hospital setting, or a low-cost home-based program. Those who undertake pulmonary rehabilitation in the hospital setting will attend the hospital twice each week for eight weeks for supervised exercise training and education. People in the home pulmonary rehabilitation group will receive one home visit and weekly telephone calls for eight weeks, for supervision and mentoring of exercise and provision of education. We will compare the number of people who complete the program in each setting. We will also test whether the groups have similar results for the standard pulmonary rehabilitation outcomes of breathlessness, quality of life and exercise capacity, at the end of the program and 12 months later. We will compare health care costs and personal costs between groups after 12 months.
If home-based pulmonary rehabilitation can improve uptake of this important treatment, deliver good clinical outcomes and reduce costs this will have significant and long-lasting benefits for patients, the community and the health system
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
- Single (Outcomes Assessor)
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
- •current or former smokers of at least 10 packet years
- •aged 40 years or over
- •diagnosis of COPD confirmed on spirometry.
排除标准
- •previous diagnosis of asthma
- •have attended a pulmonary rehabilitation program in the last two years
- •exacerbation of COPD within the last four weeks
- •have comorbidities which prevent participation in an exercise training program
结局指标
主要结局
Change in 6-minute walk test
时间窗: Baseline, 8 weeks and 12 months
Testing equivalence between groups
次要结局
- Cost-effectiveness(12 months)
- Program completion rate(8 weeks)
- SF-36 v2(Baseline, 8 weeks and 12 months)
- Change in Chronic Respiratory Disease Questionnaire(Baseline, 8 weeks and 12 months)
- Change in Modified Medical Research Council Scale(Baseline, 8 weeks and 12 months)
研究者
Anne Holland
Associate Professor
La Trobe University