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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
490
Participants will be offered the choice of HomeBase, a home-based pulmonary rehabilitation program, or the traditional centre-based pulmonary rehabilitation program.
Participants will be offered a traditional centre-based pulmonary rehabilitation program
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Mount Druitt Hospital
Sydney, New South Wales, Australia
Prince of Wales Hospital
Sydney, New South Wales, Australia
Westmead Hospital
Sydney, New South Wales, Australia
Top End Health Service
Darwin, Northern Territory, Australia
Prince Charles Hospital
Brisbane, Queensland, Australia
Central Adelaide Local Health Network
Adelaide, South Australia, Australia
Southern Adelaide Local Health Network
Adelaide, South Australia, Australia
Peninsula Health
Melbourne, Victoria, Australia
St John of God Frankston Rehabilitation
Melbourne, Victoria, Australia
...and 1 more locations
All cause, non-elective hospitalisation
The number of participants hospitalised at least once will be compared between groups
Time frame: 12 months after completing pulmonary rehabilitation
Change in 6-minute walk distance
Distance walked in 6 minutes
Time frame: End of rehabilitation and 12 months later
Change in chronic respiratory disease questionnaire total and domain scores
Disease-specific health-related quality of life measure; scores range 1-7, higher scores indicate better health-related quality of life
Time frame: End of rehabilitation and 12 months later
EQ-5D-5L
Generic health-related quality of life measure to inform economic analysis; 5 dimensions each scored 1-5 with lower values indicating better health-related quality of life
Time frame: End of rehabilitation and 12 months later
Change in dyspnoea-12
Global measure of breathlessness; total scores range from 0 to 36, with higher scores corresponding to greater severity of dyspnoea
Time frame: End of rehabilitation and 12 months later
Change in objectively measured physical activity
Objective measure of physical activity using the actigraph
Time frame: End of rehabilitation and 12 months later
Health care costs
Health care costs in Australian dollars will be calculated using health care utilisation data including hospitalisation, primary care visits and medication use
Time frame: 12 months following pulmonary rehabilitation completion
Program completion
The number of participants who complete their allocated rehabilitation program (attend at least 70% of planned sessions).
Time frame: End of rehabilitation
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