Clinical trial NCT04217330: An Implementation Trial to Improve Access to Pulmonary Rehabilitation in People With COPD
Official title: HomeBase2: An Implementation Trial to Improve Access to Pulmonary Rehabilitation in People With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Pulmonary rehabilitation
Implementation
COPD
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: Institute for Breathing and Sleep, Australia
name: University of Melbourne
name: La Trobe University
name: Thoracic Society of Australia and New Zealand
name: Lung Foundation Australia
First posted: 2020-01-03
Enrollment: 490
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized trial
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion criteria for pulmonary rehabilitation programs:

• Outpatient pulmonary rehabilitation programs that admit at least 50 people with COPD each year.

Inclusion criteria for participants:

* Diagnosis of COPD confirmed on spirometry
* Able to read, write and speak English
* Able to provide informed consent.

Exclusion Criteria:

* Attended pulmonary rehabilitation within 1 year
* Comorbidities which preclude exercise training.

Primary outcomes:
measure: All cause, non-elective hospitalisation
timeFrame: 12 months after completing pulmonary rehabilitation
Secondary outcomes:
measure: Change in 6-minute walk distance
timeFrame: End of rehabilitation and 12 months later
measure: Change in chronic respiratory disease questionnaire total and domain scores
timeFrame: End of rehabilitation and 12 months later
measure: EQ-5D-5L
timeFrame: End of rehabilitation and 12 months later
measure: Change in dyspnoea-12
timeFrame: End of rehabilitation and 12 months later
measure: Change in objectively measured physical activity
timeFrame: End of rehabilitation and 12 months later
measure: Health care costs
timeFrame: 12 months following pulmonary rehabilitation completion
measure: Program completion
timeFrame: End of rehabilitation
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Mount Druitt Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Darwin
country: Australia
facility: Top End Health Service
state: Northern Territory
city: Brisbane
country: Australia
facility: Prince Charles Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Central Adelaide Local Health Network
state: South Australia
city: Adelaide
country: Australia
facility: Southern Adelaide Local Health Network
state: South Australia
city: Melbourne
country: Australia
facility: Peninsula Health
state: Victoria
city: Melbourne
country: Australia
facility: St John of God Frankston Rehabilitation
state: Victoria
city: Melbourne
country: Australia
facility: Western Health
state: Victoria
Study officials:
affiliation: Monash University
name: Anne Holland
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.