跳至主要内容
临床试验/NCT04217330
NCT04217330进行中(未招募)不适用

HomeBase2: An Implementation Trial to Improve Access to Pulmonary Rehabilitation in People With Chronic Obstructive Pulmonary Disease

Monash University13 个研究点 分布在 1 个国家目标入组 490 人开始时间: 2021年3月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne E Holland PhD, FThorSoc

Professor of Physiotherapy

Monash University

研究点 (13)

Loading locations...

相似试验