ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622001501730

Ethics application status

Approved

Date submitted

10/11/2022

Date registered

1/12/2022

Date last updated

26/11/2023

Date data sharing statement initially provided

1/12/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Implementing Pulmonary Rehabilitation in Primary care: Feasibility, acceptability, and safety

Scientific title

Implementing Pulmonary Rehabilitation in Primary care: Feasibility, acceptability, and safety

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

PURE PRIME

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic obstructive pulmonary disease (COPD)

Condition category

Condition code

Respiratory

Chronic obstructive pulmonary disease

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The aim of this study is to investigate whether upskilling private practice physiotherapists and accredited exercise physiologists (AEP) to provide pulmonary rehabilitation (PR) in the primary care setting is feasible to implement, acceptable to stakeholders and effective in achieving the known beneficial outcomes of PR. The study consists of two parts.

Part one:
Clinician participants will be given access to the Lung Foundation Australia Pulmonary Rehabilitation Online Training Program. The program is a 6-8 hour online training program that aims to increase the knowledge and confidence of health professionals to deliver evidence-based PR. The course includes modules on:
• Establishing a pulmonary rehabilitation program
• The respiratory system and COPD
• Comprehensive patient assessment
• Patient assessment – Spirometry
• Patient assessment – Assessing exercise capacity
• Patient Assessment – Quality of life
• Exercise training
• Patient education
• Program evaluation and troubleshooting

The online training will be delivered online on a learning platform with interactive infographics, text and animation. Participants will complete the course at their own pace within the 3 weeks prior to their practical module. The program duration is approximately 6-8 hours. Completion of modules will be monitored by the learning platform analytics.

After completion of the online training program, participants will attend a practical face-to-face module. Attendance will be monitored by session attendance logs. The practical module will be a group session, delivered by experts in pulmonary rehabilitation. It is estimated to that practical module will be a single 3-4 hour session. The maximum participants to facilitator ratio will be 3:1. The practical module will focus on practical aspects of content from the online program, including:
• Performing exercise capacity tests
• Exercise prescription
Participants will be followed up 3-months after completing the training, prior to commencing Part Two of the study.

Part two:
Patient participants in the intervention group will undertake twice weekly PR at an allocated physiotherapy / exercise physiology practice for 8-weeks. After Visit 1 is completed, participants will be booked into the next available spot in the PR program. Private practice PR programs can be rolling or cohort programs with a minimum of 3 and a maximum of 8 participants in any one cohort. There should not be more than 2 weeks between Visit 1 and the commencement of the intervention.

PR sessions will follow the Australian and New Zealand Pulmonary Rehabilitation guidelines and consist of at a minimum 30 minutes of lower limb endurance training, strength training and a home exercise program. Physiotherapists or AEPs delivering the intervention will prescribe each participant’s exercise program for each PR session in accordance with the current evidence-based practice guidelines. As per the training clinician participants were given in Part one of the study, participants will be prescribed lower limb endurance exercise intensity based on their baseline exercise capacity assessment. Intensity will be progressed throughout the intervention based on symptoms (measured by Borg dyspnoea scale). Upper and lower limb strength exercises will be prescribed from symptoms, measured by Borg scale. Exact exercises will be left to the physiotherapist or AEPs discretion and will consider existing exercise equipment at their practice, participant goals and past medical history. All intervention sessions must contain a walking exercise component, either treadmill walking or ground walking. Other examples of exercises may be stationary cycling, upper and lower limb strengthening exercises using resistance bands or free weights. Clinicians must document the mode, duration, intensity, type, and progression for each exercise prescribed. Frequency should be defined in the home exercise program.

The home exercise program will be individualised and progressive. Home exercise programs will be performed at a minimum of once per week, the content of the home exercise program will be determined by the treating clinician.

Session attendance logs and participant exercise logs will be used to monitor intervention fidelity.

Intervention code [1]

Rehabilitation

Comparator / control treatment

Participants in Part One will undergo pre-training program assessments, these will be used for comparison to the post-program assessments.

The control group in Part Two will continue to receive usual care from their GP throughout participation in the trial. After completion of all study procedures at Visit 2, participants will be able to commence PR at the service where they were originally referred.

Control group

Active

Outcomes

Primary outcome [1]

Part One: Change in participant content knowledge as measured by knowledge questionnaire before and after training course. The knowledge questionnaire has been designed specifically for this study.

Timepoint [1]

Prior to and at the completion of the training program

Primary outcome [2]

Part Two: Proportion of randomised participants who complete the intervention by audit of session logs

Timepoint [2]

Conclusion of the study

Primary outcome [3]

Part One: Change in participant self-rated confidence, knowledge and skills questionnaire before and after training course. The questionnaire has been designed specifically for this study.

Timepoint [3]

Prior to and at the completion of the training program

Secondary outcome [1]

Part One: Proportion of participants meeting proficiency threshold in practical skills assessment. Proficiency will be measured by a competency rubric specifically designed for this study.

Timepoint [1]

Completion of training program

Secondary outcome [2]

Part One: Maintenance of participant knowledge 3 months post training program measured by the knowledge questionnaire designed for this study.

Timepoint [2]

3 months after completion of training program

Secondary outcome [3]

Part One: Proportion of participants meeting proficiency threshold in knowledge questionnaire. The knowledge questionnaire was design specifically for this study.

Timepoint [3]

Prior to, at the completion of and at 3 months after the training program

Secondary outcome [4]

Part One: Change in participant self-rated confidence, knowledge, and skills questionnaire. This questionnaire was designed specifically for this study.

Timepoint [4]

3 months after the training program

Secondary outcome [5]

Part Two: Proportion of eligible participants randomised. Measured by audit of screening log.

Timepoint [5]

Conclusion of the study

Secondary outcome [6]

Part Two: Proportion of PR sessions where private practice clinicians provide exercise prescriptions of appropriate intensity and duration. This will be assessed through audit of participant exercise logs.

Timepoint [6]

Conclusion of study

Secondary outcome [7]

Part Two: Proportion of missing data, measured by audit of study databases.

Timepoint [7]

Conclusion of study

Secondary outcome [8]

Part Two: Change in exercise capacity (6-minute walk test OR incremental shuttle walk test, 1-minute sit-to-stand test)

Timepoint [8]

Prior to and after 8-week PP PR intervention or 8-week control period

Secondary outcome [9]

Part Two: Number of adverse events. Adverse events will be assessed or recorded during study visits and intervention sessions. Adverse events may be illnesses that occur outside of the study or any adverse events that occur during the intervention, for example musculoskeletal injury.

Timepoint [9]

Conclusion of the study

Secondary outcome [10]

Qualitative outcomes: Patient participant experience of participating in the trial measured by one-on-one semi-structured interviews with a member of the research team.

Timepoint [10]

Conclusion of the study

Secondary outcome [11]

Part Two: Change in HRQoL (St George’s Respiratory Questionnaire)

Timepoint [11]

Prior to and after 8-week PP PR intervention or 8-week control period

Secondary outcome [12]

Part Two: Change in Health status (COPD Assessment Test)

Timepoint [12]

Prior to and after 8-week PP PR intervention or 8-week control period

Secondary outcome [13]

Qualitative outcomes: Clinician participant experience of participating in the trial measured by one-on-one semi-structured interviews with a member of the research team.

Timepoint [13]

Conclusion of the study

Secondary outcome [14]

Qualitative outcomes: Barriers and facilitators to trial participation and completion measured by one-on-one semi-structured interviews with a member of the research team.

Timepoint [14]

Conclusion of the study

Secondary outcome [15]

Qualitative outcomes: Exploration of intervention feasibility from a business model perspective measured by one-on-one semi-structured interviews with a member of the research team.

Timepoint [15]

Conclusion of the study

Eligibility

Key inclusion criteria

Clinician participants:
• AHPRA registered physiotherapist or Exercise & Sports Science Australia accredited exercise physiologist
• Working in private practice where:
o At least two staff (clinical or administrative) are present during assessments or group exercise sessions
o There is adequate space for group exercise (minimum 3 participants) to occur
o Accessible for people with chronic respiratory disease
• Willing to provide intervention for part two of study (twice weekly PR for 8-weeks)
• Have or be willing to obtain current CPR training prior to assessing any study participants

Patient participants:
• Age greater than 18 years
• Diagnosis of COPD (confirmed by spirometry or diagnosis by medical doctor, symptomatically breathless and smoking history) or diagnosis of interstitial lung disease (ILD) (diagnosis by medical doctor)
• Referred to pulmonary rehabilitation at Sydney Local Health District, South Eastern Sydney Local Health District or South Western Sydney Local Health District and on the waiting list
• Willing to attend twice weekly PR for 8 weeks in a private practice setting

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Clinician participants:
• Physiotherapists or AEPs with significant prior PR experience (more than one rotation as Level 1 clinician, or delivery of Lungs in Action)
• Physiotherapists or AEPs with post-graduate cardiopulmonary qualifications

Patient participants:
• Exacerbation of respiratory disease within 4 weeks prior to recruitment
• Completed PR in the past year
• Prescribed home supplemental oxygen or requiring supplemental oxygen for exercise (desaturates < 80% SpO2 on field walking test)
• Medical conditions that contraindicate safe group exercise outside hospital setting (e.g. unstable cardiac disease, severe musculoskeletal impairments)
• Unable to provide informed consent

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Participants will be randomised in a de-identified manner using a central randomisation process by computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Random allocation 1:1 ratio to the intervention group or the control group. Randomisation will be stratified according to exercise capacity and FEV1.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Sample size calculation
Part one:
We aim to recruit 15 participants to detect a 7.6-point change in participant knowledge post-training with 80% power and a standard deviation of 4.3 points, accounting for 20% attrition.
Part two:
As this is a feasibility trial designed to test the feasibility for a future definitive trial, a formal sample size calculation is not appropriate. However, Browne et al. recommend a minimum of 30 participants per study arm to estimate a parameter for any future sample size calculation. Therefore, allowing for 20% attrition rate, 76 participants will be recruited.

Statistical analysis plan
Part one:
Quantitative data will be first summarised using descriptive statistics. Likert scales will be analysed as ordinal scales, 5-point scales will have values from -2 to +2 assigned. Change data will be analysed over all timepoints using ANOVA, followed by t-tests to determine where significant change occurred.

Part two:
Data will be analysed in accordance with CONSORT extension for randomised pilot and feasibility trials guidelines. Intention-to-treat analysis will be used. Feasibility outcomes will be described using proportions and corresponding 95% confidence intervals (CI), or for continuous variables means, standard deviations and ranges. The proportion of missing data will be summarised for each clinical outcome at each timepoint. Where possible, reasons for missing data will be recorded. Descriptive statistics will summarise clinical outcomes and effect sizes estimated. Change data for field walking tests (6MWT and ISWT) will be presented as percentage changes. The proportion of participants who meet the minimum important differences for each test will be calculated. For all other clinical outcomes change data will be presented as absolute changes. Between group differences will be calculated with 95% CI but keeping with the feasibility design, inferential statistics will not be used.

Qualitative data analysis:
Semi-structured interviews will be transcribed verbatim. Interview transcripts will be examined for emergent themes using an inductive thematic analysis by five key stages. These stages are familiarisation, coding, theme development, defining themes and reporting. NVivo will be used to assist analysis. Recruitment for interviews will continue until data saturation is achieved.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

27/03/2023

Actual

25/05/2023

Date of last participant enrolment

Anticipated

31/10/2025

Actual

Date of last data collection

Anticipated

31/12/2025

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [2]

Liverpool Hospital - Liverpool

Recruitment hospital [3]

Prince of Wales Hospital - Randwick

Recruitment hospital [4]

The Sutherland Hospital - Caringbah

Recruitment postcode(s) [1]

2050 - Camperdown

Recruitment postcode(s) [2]

2170 - Liverpool

Recruitment postcode(s) [3]

2031 - Randwick

Recruitment postcode(s) [4]

2229 - Caringbah

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Better Breathing Foundation

Address [1]

7 Blaxland St, Hunters Hill, NSW, 2110

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Lung Foundation Australia

Address [2]

Level 2, 11 Finchley St, Milton, Queensland, 4064

Country [2]

Australia

Primary sponsor type

University

Name

University of Sydney

Address

University of Sydney, Camperdown, NSW, 2006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District - RPAH Zone

Ethics committee address [1]

Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/11/2022

Approval date [1]

24/02/2023

Ethics approval number [1]

Summary

Brief summary

This study aims to investigate whether pulmonary rehabilitation (PR) can be conducted in private physiotherapy and exercise physiology practices. The study consists of two parts, part one involves training clinician participants in PR and part two involves provision of PR by those clinicians upskilled in part one to provide PR to patient participants. In part one, clinician participants will undertake a training program in PR. This will be evaluated using short questionnaires and practical assessment of skills, knowledge and confidence before, after and 3-month following the training program. In part two, people with COPD will be randomly allocated to either an 8-week private practice PR program or usual care. We will measure the feasibility to provide PR in this setting as well as measuring clinical outcomes such as exercise capacity and health-related quality of life. Both patient and clinician participants will be invited to complete semi-structured interviews.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Sarah Dennis

Address

Level 7, Susan Wakil Health Building,
University of Sydney, NSW, 2006

Country

Australia

Phone

+61459898398

Fax

[email protected]

Contact person for public queries

Name

Jessica Walsh

Address

Susan Wakil Health Building,
University of Sydney, NSW, 2006

Country

Australia

Phone

+61 481127212

Fax

[email protected]

Contact person for scientific queries

Name

Sarah Dennis

Address

Level 7, Susan Wakil Health Building,
University of Sydney, NSW, 2006

Country

Australia

Phone

+61459898398

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
17428	Study protocol			[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically