Chronic Obstructive Pulmonary DiseaseHomeBase2NCT04217330
An Implementation Trial to Improve Access to Pulmonary Rehabilitation in People With COPD
A study testing Choice of home-based or centre-based pulmonary rehabilitation and Centre-based pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Monash University at 11 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Choice of home-based or centre-based pulmonary rehabilitation and Centre-based pulmonary rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 439 participants
- Where
- 11 sitesAustralia
- Study dates
- 1 Mar 2021to 10 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Outpatient pulmonary rehabilitation programs that admit at least 50 people with COPD each year.
- Diagnosis of COPD confirmed on spirometry
- Able to read, write and speak English
- Able to provide informed consent.
Who cannot join
- Attended pulmonary rehabilitation within 1 year
- Comorbidities which preclude exercise training.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Australia11 sites
Central Adelaide Local Health Network
Adelaide, South Australia
Southern Adelaide Local Health Network
Adelaide, South Australia
Prince Charles Hospital
Brisbane, Queensland, 4032
Top End Health Service
Darwin, Northern Territory
Peninsula Health
Melbourne, Victoria
St John of God Frankston Rehabilitation
Melbourne, Victoria
Western Health
Melbourne, Victoria
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
Mount Druitt Hospital
Sydney, New South Wales
Prince of Wales Hospital
Sydney, New South Wales
Westmead Hospital
Sydney, New South Wales
About this study
Official title: HomeBase2: An Implementation Trial to Improve Access to Pulmonary Rehabilitation in People With Chronic Obstructive Pulmonary Disease
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Choice of home-based or centre-based pulmonary rehabilitation, Centre-based pulmonary rehabilitation
- Keywords
- Pulmonary rehabilitation, Implementation, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choice of home-based or centre-based pulmonary rehabilitationBehavioural
Participants will be offered the choice of HomeBase, a home-based pulmonary rehabilitation program, or the traditional centre-based pulmonary rehabilitation program.
Centre-based pulmonary rehabilitationBehavioural
Participants will be offered a traditional centre-based pulmonary rehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Choice of home-based or 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. Receives: Behavioral: Centre-based pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause, non-elective hospitalisation
The number of participants hospitalised at least once will be compared between groups
Measured: 12 months after completing pulmonary rehabilitation
Secondary outcomes (7)
Change in 6-minute walk distance
Distance walked in 6 minutes
Measured: 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
Measured: 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
Measured: 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
Measured: End of rehabilitation and 12 months later
Change in objectively measured physical activity
Objective measure of physical activity using the actigraph
Measured: 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
Measured: 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).
Measured: End of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start1 Mar 2021
- Primary completion10 Apr 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Breathing and Sleep, Australia, University of Melbourne, La Trobe University, Thoracic Society of Australia and New Zealand, Lung Foundation Australia
- Responsible party
- Principal investigator, Anne E Holland PhD, FThorSoc, Monash University
- Investigators
- Anne Holland, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217330
- Sponsor's protocol ID
- 55803
- Acronym
- HomeBase2
- Status last verified
- Oct 2026
- First submitted
- 17 Dec 2019
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36890526Holland 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.
PubMed 35410931
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HomeBase2: An Implementation Trial to Improve Access to Pulmonary Rehabilitation in People With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04217330
- Acronym / sponsor ID
- HomeBase2 / 55803
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Pulmonary rehabilitation, Implementation, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- Institute for Breathing and Sleep, Australia, University of Melbourne, La Trobe University, Thoracic Society of Australia and New Zealand, Lung Foundation Australia
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Choice of home-based or centre-based pulmonary rehabilitationPulmonary 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 | Behavioral: Centre-based pulmonary rehabilitationPulmonary 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Outpatient pulmonary rehabilitation programs that admit at least 50 people with COPD each year.
- Diagnosis of COPD confirmed on spirometry
- Able to read, write and speak English
- Able to provide informed consent.
Key exclusion criteria (2 listed)
- Attended pulmonary rehabilitation within 1 year
- Comorbidities which preclude exercise training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Choice of home-based or centre-based pulmonary rehabilitationParticipants will be offered the choice of HomeBase, a home-based pulmonary rehabilitation program, or the traditional centre-based pulmonary rehabilitation program. | Behavioural | Intervention |
| Centre-based pulmonary rehabilitationParticipants will be offered a traditional centre-based pulmonary rehabilitation program | Behavioural | Control |
Primary outcome
All cause, non-elective hospitalisation
Time frame: 12 months after completing pulmonary rehabilitation
The number of participants hospitalised at least once will be compared between groups
7 secondary outcomes
Change in 6-minute walk distance
Time frame: End of rehabilitation and 12 months later
Change in chronic respiratory disease questionnaire total and domain scores
Time frame: End of rehabilitation and 12 months later
EQ-5D-5L
Time frame: End of rehabilitation and 12 months later
Change in dyspnoea-12
Time frame: End of rehabilitation and 12 months later
Change in objectively measured physical activity
Time frame: End of rehabilitation and 12 months later
Health care costs
Time frame: 12 months following pulmonary rehabilitation completion
Program completion
Time frame: End of rehabilitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Derived from this study: PubMed 36890526Cox 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.
- Derived from this study: PubMed 35410931Holland 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Holland principal investigator
Monash University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Choice of home-based or centre-based pulmonary rehabilitation and Centre-based pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Monash University at 11 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause, non-elective hospitalisation (time frame: 12 months after completing pulmonary rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04217330, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.