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| Name | Class |
|---|---|
| Institute for Breathing and Sleep, Australia | OTHER |
| University of Melbourne | OTHER |
| La Trobe University | OTHER |
| Thoracic Society of Australia and New Zealand |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Pulmonary rehabilitation programs assigned to the intervention group will offer eligible participants the choice of participating in an 8-week program of either home-based pulmonary rehabilitation or traditional centre-based pulmonary rehabilitation. |
|
| Control | Active Comparator | Pulmonary rehabilitation programs assigned to the control group will offer eligible participants the opportunity to participate in an 8-week centre-based pulmonary rehabilitation program, as per current practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Choice of home-based or centre-based pulmonary rehabilitation | Behavioral | Participants will be offered the choice of HomeBase, a home-based pulmonary rehabilitation program, or the traditional centre-based pulmonary rehabilitation program. |
| Measure | Description | Time Frame |
|---|---|---|
| All cause, non-elective hospitalisation | The number of participants hospitalised at least once will be compared between groups | 12 months after completing pulmonary rehabilitation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6-minute walk distance | Distance walked in 6 minutes | 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 |
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Inclusion criteria for pulmonary rehabilitation programs:
• Outpatient pulmonary rehabilitation programs that admit at least 50 people with COPD each year.
Inclusion criteria for participants:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Holland | Monash University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Sydney | New South Wales | 2050 | Australia | ||
| Mount Druitt Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36890526 | Derived | Cox NS, Holland AE, Jones AW, McDonald CF, O'Halloran P, Mahal A, Hepworth G, Lannin NA. Implementation of offering choice of pulmonary rehabilitation location to people with COPD: a protocol for the process evaluation of a cluster randomised controlled trial. Trials. 2023 Mar 8;24(1):173. doi: 10.1186/s13063-023-07179-2. | |
| 35410931 |
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The investigators will make individual participant data available to other researchers for related projects with appropriate ethical oversight. The data provided would be in re-identifiable form with no identifying information provided. Access will only be granted to researchers who agree to preserve the confidentiality of the information. Access will require approval from the research team as well as approval from a Human Research Ethics Committee.
After publication of the main trial results, for 7 years.
Access will only be granted to researchers who agree to preserve the confidentiality of the information. Access will require approval from the research team as well as approval from a Human Research Ethics Committee
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| UNKNOWN |
| Lung Foundation Australia | UNKNOWN |
Cluster randomized trial
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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.
| Centre-based pulmonary rehabilitation | Behavioral | Participants will be offered a traditional centre-based pulmonary rehabilitation program |
|
| 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 | 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 | End of rehabilitation and 12 months later |
| Change in objectively measured physical activity | Objective measure of physical activity using the actigraph | 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 | 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). | End of rehabilitation |
| 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 | 4032 | 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 |
| Western Health | Melbourne | Victoria | Australia |
| Holland AE, Jones AW, Mahal A, Lannin NA, Cox N, Hepworth G, O'Halloran P, McDonald CF. Implementing a choice of pulmonary rehabilitation models in chronic obstructive pulmonary disease (HomeBase2 trial): protocol for a cluster randomised controlled trial. BMJ Open. 2022 Apr 11;12(4):e057311. doi: 10.1136/bmjopen-2021-057311. |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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