Trial Review

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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] 308216 0
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) 327974 0
Condition category
Condition code
Respiratory 325031 325031 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 325032 325032 0 0
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] 324678 0
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] 332849 0
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] 332849 0
Prior to and at the completion of the training program
Primary outcome [2] 332850 0
Part Two: Proportion of randomised participants who complete the intervention by audit of session logs
Timepoint [2] 332850 0
Conclusion of the study
Primary outcome [3] 333202 0
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] 333202 0
Prior to and at the completion of the training program
Secondary outcome [1] 414867 0
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] 414867 0
Completion of training program
Secondary outcome [2] 414961 0
Part One: Maintenance of participant knowledge 3 months post training program measured by the knowledge questionnaire designed for this study.
Timepoint [2] 414961 0
3 months after completion of training program
Secondary outcome [3] 414962 0
Part One: Proportion of participants meeting proficiency threshold in knowledge questionnaire. The knowledge questionnaire was design specifically for this study.
Timepoint [3] 414962 0
Prior to, at the completion of and at 3 months after the training program
Secondary outcome [4] 414963 0
Part One: Change in participant self-rated confidence, knowledge, and skills questionnaire. This questionnaire was designed specifically for this study.
Timepoint [4] 414963 0
3 months after the training program
Secondary outcome [5] 414964 0
Part Two: Proportion of eligible participants randomised. Measured by audit of screening log.
Timepoint [5] 414964 0
Conclusion of the study
Secondary outcome [6] 414965 0
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] 414965 0
Conclusion of study
Secondary outcome [7] 414966 0
Part Two: Proportion of missing data, measured by audit of study databases.
Timepoint [7] 414966 0
Conclusion of study
Secondary outcome [8] 414967 0
Part Two: Change in exercise capacity (6-minute walk test OR incremental shuttle walk test, 1-minute sit-to-stand test)

Timepoint [8] 414967 0
Prior to and after 8-week PP PR intervention or 8-week control period
Secondary outcome [9] 414968 0
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] 414968 0
Conclusion of the study
Secondary outcome [10] 414969 0
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] 414969 0
Conclusion of the study
Secondary outcome [11] 416129 0
Part Two: Change in HRQoL (St George’s Respiratory Questionnaire)
Timepoint [11] 416129 0
Prior to and after 8-week PP PR intervention or 8-week control period
Secondary outcome [12] 416130 0
Part Two: Change in Health status (COPD Assessment Test)
Timepoint [12] 416130 0
Prior to and after 8-week PP PR intervention or 8-week control period
Secondary outcome [13] 416133 0
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] 416133 0
Conclusion of the study
Secondary outcome [14] 416134 0
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] 416134 0
Conclusion of the study
Secondary outcome [15] 416135 0
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] 416135 0
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?
No
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
91
Accrual to date
26
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23423 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 23426 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 24926 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 25723 0
The Sutherland Hospital - Caringbah
Recruitment postcode(s) [1] 38825 0
2050 - Camperdown
Recruitment postcode(s) [2] 38828 0
2170 - Liverpool
Recruitment postcode(s) [3] 40578 0
2031 - Randwick
Recruitment postcode(s) [4] 41548 0
2229 - Caringbah

Funding & Sponsors
Funding source category [1] 312474 0
Charities/Societies/Foundations
Name [1] 312474 0
Better Breathing Foundation
Country [1] 312474 0
Australia
Funding source category [2] 312492 0
Charities/Societies/Foundations
Name [2] 312492 0
Lung Foundation Australia
Country [2] 312492 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney, Camperdown, NSW, 2006
Country
Australia
Secondary sponsor category [1] 314165 0
None
Name [1] 314165 0
Address [1] 314165 0
Country [1] 314165 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311817 0
Sydney Local Health District - RPAH Zone
Ethics committee address [1] 311817 0
Ethics committee country [1] 311817 0
Australia
Date submitted for ethics approval [1] 311817 0
28/11/2022
Approval date [1] 311817 0
24/02/2023
Ethics approval number [1] 311817 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122470 0
Prof Sarah Dennis
Address 122470 0
Level 7, Susan Wakil Health Building,
University of Sydney, NSW, 2006
Country 122470 0
Australia
Phone 122470 0
+61459898398
Fax 122470 0
Email 122470 0
sarah.dennis@sydney.edu.au
Contact person for public queries
Name 122471 0
Jessica Walsh
Address 122471 0
Susan Wakil Health Building,
University of Sydney, NSW, 2006
Country 122471 0
Australia
Phone 122471 0
+61 481127212
Fax 122471 0
Email 122471 0
jwal2265@uni.sydney.edu.au
Contact person for scientific queries
Name 122472 0
Sarah Dennis
Address 122472 0
Level 7, Susan Wakil Health Building,
University of Sydney, NSW, 2006
Country 122472 0
Australia
Phone 122472 0
+61459898398
Fax 122472 0
Email 122472 0
sarah.dennis@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17428Study protocol  jwal2265@uni.sydney.edu.au



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.