Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001296527
Ethics application status
Approved
Date submitted
28/09/2024
Date registered
25/10/2024
Date last updated
25/10/2024
Date data sharing statement initially provided
25/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of implementing a treatable traits approach on care of high risk chronic respiratory disease (the TAPPET trial)
Scientific title
Targeted Approach for Preventing Pulmonary and Extra-pulmonary Traits: the TAPPET trial
Secondary ID [1] 313056 0
105170
Universal Trial Number (UTN)
Trial acronym
TAPPET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 335303 0
Bronchiectasis 335304 0
Chronic Obstructive Pulmonary Disease 335305 0
Condition category
Condition code
Respiratory 331874 331874 0 0
Asthma
Respiratory 331875 331875 0 0
Chronic obstructive pulmonary disease
Respiratory 331876 331876 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Medical management of asthma, bronchiectasis or COPD according to local standard of care and receive an 8-week intervention consisting of home pulmonary rehabilitation and self-management. The 8-week intervention will include:

Home visits: The program will commence with a home visit (within 2 weeks of study enrolment, 60 to 120 minutes) by a physiotherapist, exercise physiologist or nurse who will establish exercise goals and supervise the first exercise session. The home visit will also undertake a review of inhaler technique and airway clearance. Participants will complete a modified incremental step test (MIST) in the initial home visit to support exercise prescription. Participants will have a second home visit at 8 weeks where the physiotherapist will reassess exercise capacity using the MIST and discuss a long-term exercise plan including referral to local maintenance exercise programs.

Unsupervised exercise training: The program will deliver an unsupervised aerobic and strength training program for 8 weeks to target key sources of systemic inflammation (skeletal muscle and adipose tissue). For the aerobic training, a walking program will be prescribed with participants set a walking distance to be completed in a given time, with distance measurement aided by pedometers. At least 30 minutes of aerobic exercise is recommended for each session, for at least 5 sessions per week. Strength training will utilise functional activities and equipment that are readily accessible at home (e.g. sit-to-stand from a dining chair), with at least two upper-limb and two lower-limb exercises prescribed for completion twice weekly (15 to 30 minutes total per session).

Home exercise diary: Exercise goals and details of completed unsupervised exercise sessions will be documented in a home exercise diary each week. Prior to each unsupervised exercise session, participants will be prompted to complete a checklist (based on signs of a moderate or severe exacerbation e.g. increased dyspnoea, cough or sputum, using more reliever medication) in the diary to ensure clinical stability. Participants will be instructed to contact their local clinician if they have symptoms of an exacerbation to ensure appropriate exercise participation during and following chest infections.

Weekly telephone calls: The initial home visit will be followed by seven once-weekly telephone calls (approximately 30 minutes each) by a physiotherapist. The physiotherapist will: (1) review symptoms and facilitate self-management of exacerbations as per the diary checklist; (2) review the home exercise diary; (3) progress the exercise prescription; and (4) deliver self-management education targeting systemic inflammation and chest infections including diet and weight management, understanding medications and infection control. Each physiotherapist will maintain a call log and complete a summary at the end of the intervention to report on intervention delivery including number and duration of telephone calls, exercise progression, goals set and achieved, self-management education, referrals to other treatments and services and long-term exercise plan.

Action plans: Asthma Australia and Lung Foundation Australia have designed action plans that when completed with a health professional help people with asthma, bronchiectasis and COPD recognise early symptoms of an exacerbation and outline the actions to take. These action plans will be checked by the clinician during the initial home visit and re-visited during the telephone calls. If a participant does not have an action plan and/or existing rescue pack of antibiotics and/or oral corticosteroids to be used in conjunction with their action plan the local research team will coordinate an action plan and/or script to be prepared by the site principal Investigator or other local site physician where applicable. If any participants prefer for this to be completed in consultation with their local GP, the local research team will provide a letter for the participant to take to their GP confirming study participation and requirement for review of action plan and rescue pack script.

Disease management checklists: Asthma Australia and Lung Foundation have designed checklists to optimise self-management of asthma, bronchiectasis or COPD. These cover aspects of exercise, inhaler technique, airway clearance, review of medications, comorbidities, smoking cessation, vaccinations, nutrition or mental health support. The local site team will review the relevant checklist with the participant during the second home visit including additional treatment referrals at the local health service partner or other services provided by Asthma Australia and Lung Foundation Australia.

Educational resources: Our previous trials in COPD have provided printed educational resources of ‘Better Living with Exercise’ and ‘Better Living with COPD’ developed by Lung Foundation Australia. The provision of resources will be expanded to include written and printed educational material on asthma and bronchiectasis from Asthma Australia and Lung Foundation Australia respectively.
Intervention code [1] 329623 0
Rehabilitation
Comparator / control treatment
Medical management of asthma, bronchiectasis or COPD according to local standard of care which may include, but not limited to, inhaled bronchodilators and/or corticosteroids, biologics, macrolides, mucolytics, oxygen therapy, immunisations, referral to non-pharmacological treatments and services, or prescription of antibiotics and/or corticosteroids for an acute exacerbation of lung disease.
Control group
Active

Outcomes
Primary outcome [1] 339486 0
All-cause, non-elective hospitalisation over 12 months: the proportion of participants hospitalised at least once in the 12-month follow-up period. This primary outcome will be a composite of inpatient admissions and emergency department visits.
Timepoint [1] 339486 0
12 months following baseline (at the conclusion of the study)
Secondary outcome [1] 440169 0
All-cause non-elective inpatient admission only: the proportion of participants admitted as an inpatient at least once in the 12-month follow-up period
Timepoint [1] 440169 0
12 months following baseline (at the conclusion of the study)
Secondary outcome [2] 440170 0
All-cause non-elective inpatient admission only: total number of inpatient admissions in the 12-month follow-up period
Timepoint [2] 440170 0
12 months following baseline
Secondary outcome [3] 440172 0
All-cause emergency department visits only: the proportion of participants attending the emergency department at least once in the 12-month follow-up period
Timepoint [3] 440172 0
12 months following baseline (at the conclusion of the study)
Secondary outcome [4] 440173 0
All-cause emergency department visits only: total number of emergency department visits in the 12-month follow-up period
Timepoint [4] 440173 0
12 months following baseline
Secondary outcome [5] 440174 0
Length of stay for all-cause hospital admissions: the length of stay for inpatient admissions in the 12-month follow-up period
Timepoint [5] 440174 0
12 months following baseline
Secondary outcome [6] 440175 0
Acute exacerbations: proportion of participants to have at least one course of systemic antibiotics and/or corticosteroids but no hospitalisation for acute symptoms in the 12-month follow-up period
Timepoint [6] 440175 0
12 months following baseline (at the conclusion of the study)
Secondary outcome [7] 440176 0
Acute exacerbations: Total number requiring systemic antibiotics and/or corticosteroids but no hospitalisation for acute symptoms in the 12-month follow-up period
Timepoint [7] 440176 0
12 months following baseline
Secondary outcome [8] 440177 0
Systemic inflammation: change in C-reactive protein
Timepoint [8] 440177 0
Screening/baseline and at 10 weeks and 12 months following baseline
Secondary outcome [9] 440178 0
Systemic inflammation: change in total white blood cell count
Timepoint [9] 440178 0
Screening/baseline and at 10 weeks and 12 months following baseline
Secondary outcome [10] 440179 0
Change in differential white blood cell count: neutrophils
Timepoint [10] 440179 0
Screening/baseline and at 10 weeks and 12 months following baseline
Secondary outcome [11] 440180 0
Change in differential white blood cell count: lymphocytes
Timepoint [11] 440180 0
Screening/baseline and at 10 weeks and 12 months following baseline
Secondary outcome [12] 440195 0
Change in differential white blood cell count: monocytes
Timepoint [12] 440195 0
Screening/baseline and at 10 weeks and 12 months following baseline
Secondary outcome [13] 440196 0
Change in differential white blood cell count: eosinophils
Timepoint [13] 440196 0
Screening/baseline and at 10 weeks and 12 months following baseline
Secondary outcome [14] 440197 0
Change in differential white blood cell count: basophils
Timepoint [14] 440197 0
Screening/baseline and at 10 weeks and 12 months following baseline

Eligibility
Key inclusion criteria
i. clinical diagnosis of asthma, bronchiectasis and/or chronic obstructive pulmonary disease (COPD)
ii. two or more courses of systemic antibiotics and/or corticosteroids in the previous 12 months
iii. white blood cell count > 9 × 10^9/L or plasma CRP concentration > 3 mg/L
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. less than 4 weeks following an exacerbation of their respiratory disease (requiring hospitalisation or treatment with systemic antibiotics or corticosteroids)
ii. comorbidities which preclude exercise training
iii. inability to read, write or speak English
iv. have undergone a pulmonary rehabilitation program in the previous 12 months

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)
Cluster randomisation of programs will be used to minimise the risk of contamination across
intervention and control groups. Health facilities/hospitals will be randomised using a web-based randomisation program managed by an independent agency.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sixteen clusters will be randomised 1:1 to intervention or control using computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The trial will be reported in accordance with the CONSORT extension for cluster randomised trials. Binary clinical outcomes, including the primary outcome, will be analysed using log-binomial regression models fit via generalised estimating equations with an exchangeable working correlation structure to account for clustering by site and presented as relative risks and risk differences. Small numbers of clusters will be accounted for using small sample corrections. Changes in CRP and white blood cell counts, and the logarithm of hospital length of stay will be analysed via mixed linear regression models. Analyses will be based on intention-to-treat with level of significance set at p < 0.05. A full statistical analysis plan will be developed prior to the final database lock and made publicly available.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
448
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317498 0
Government body
Name [1] 317498 0
Medical Research Future Fund (MRFF) on behalf of the Department of Health and Aged Care
Country [1] 317498 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 319814 0
None
Name [1] 319814 0
Address [1] 319814 0
Country [1] 319814 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316209 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316209 0
Ethics committee country [1] 316209 0
Australia
Date submitted for ethics approval [1] 316209 0
06/03/2024
Approval date [1] 316209 0
28/06/2024
Ethics approval number [1] 316209 0
143/24

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

Contacts
Principal investigator
Name 137154 0
Dr Arwel Jones
Address 137154 0
Respiratory Research@Alfred, School of Translational Medicine, Monash University, Level 6 Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004
Country 137154 0
Australia
Phone 137154 0
+61 3 9903 0842
Fax 137154 0
Email 137154 0
arwel.jones@monash.edu
Contact person for public queries
Name 137155 0
Arwel Jones
Address 137155 0
Respiratory Research@Alfred, School of Translational Medicine, Monash University, Level 6 Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004
Country 137155 0
Australia
Phone 137155 0
+61 3 9903 0842
Fax 137155 0
Email 137155 0
arwel.jones@monash.edu
Contact person for scientific queries
Name 137156 0
Arwel Jones
Address 137156 0
Respiratory Research@Alfred, School of Translational Medicine, Monash University, Level 6 Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004
Country 137156 0
Australia
Phone 137156 0
+61 3 9903 0842
Fax 137156 0
Email 137156 0
arwel.jones@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data exported from trial database (no access to Services Australia data).
When will data be available (start and end dates)?
Following publication of trial results; no end date.
Available to whom?
Accessible to other researchers upon reasonable request to Principal Investigator (case-by-case basis).
Available for what types of analyses?
Related research questions that have permission from an appropriately constituted Human Research Ethics Committee.
How or where can data be obtained?
Stored securely in repository provided by Monash University. Access subject to permission by Principal Investigator (arwel.jones@monash.edu) and appropriate ethical oversight.


What supporting documents are/will be available?

No Supporting Document Provided



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.