Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000867796
Ethics application status
Approved
Date submitted
26/03/2022
Date registered
17/06/2022
Date last updated
14/01/2024
Date data sharing statement initially provided
17/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of telehealth physiotherapy for adults with bronchiectasis
Scientific title
Feasibility of telehealth physiotherapy for adults with bronchiectasis
Secondary ID [1] 306096 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 324760 0
Condition category
Condition code
Respiratory 322213 322213 0 0
Other respiratory disorders / diseases
Physical Medicine / Rehabilitation 323214 323214 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be offered up to four individualised telehealth sessions over 12 months, guided by minimum number recommended; the schedule will be determined by the clinician and participant, with each session approximately 90 minutes in duration. The same physiotherapist (with 20 years’ experience) will deliver the intervention to participants.
Physiotherapy sessions will consist of a personalised and pragmatic approach to assessment and treatment within each consultation to meet individual participants needs. Assessment and intervention will be specified using a fidelity checklist, and will include air way clearance technique prescription, including frequency and duration, with video resources accessed from Bronchiectasis Toolbox and Lung Foundation Australia websites. Recommendations for exercise therapy and self-management will be included as required. Airway clearance devices (OPEP devices – PARI, Aerobika) and exercise equipment (Theraband) will be provided to patients based on individual assessment of need. Advice for managing comorbidities which are amenable to physiotherapy interventions will be provided and referrals to services (Pain management, Falls and Balance, Pulmonary Rehabilitation) will be made as appropriate. Referrals to other healthcare professionals for managing other comorbidities (continence, sinusitis) will be completed.
Overall, the focus of assessment and treatment interventions included in the sessions align with recommendations for physiotherapy practice.
Attendance rates and compliance with intervention will be measured by the completion of a patient diary and by the treating physiotherapist. Fidelity will be assessed by the recording of treatment sessions and analysis by an independent investigator in line with a fidelity checklist
Intervention code [1] 322508 0
Treatment: Other
Comparator / control treatment
For participants who elect to be in the control group, they will be encouraged to continue with their usual medical and physiotherapy regimen for 12 months (standard care). They will not be provided any physiotherapy intervention during this time frame via telehealth (current practice in patient recruitment pool ). Should they be admitted to hospital with an acute exacerbation, they will receive the necessary physiotherapy care.
Control group
Active

Outcomes
Primary outcome [1] 330363 0
Feasibility of provision of physiotherapy using a Telehealth model..
This will be determined by a review of (as a composite):
1) Participants meeting eligibility criteria from within Monash Health Respiratory outpatient clinics.

2) Uptake of telehealth by eligible participants including recording reasons for declining the intervention at the point of recruitment into the study

3) Patient satisfaction : using telehealth patient satisfaction questionnaire and 90minute semi-structured recorded phone interview by independent researcher at end of 12mth intervention (intervention group only)

4) Engagement : Data will be collected for the number of intervention sessions completed per participant will be collected by audit of physiotherapy attendance records, and number of participants who complete the program (intervention group only).
Timepoint [1] 330363 0
Baseline and 12mths after recruitment
Secondary outcome [1] 410590 0
Clinical outcomes: Disease specific QOL: Quality of Life (Bronchiectasis) (QOL - B) tool completed by both intervention and control group participants
Timepoint [1] 410590 0
Baseline and 12 months after recruitment
Secondary outcome [2] 410591 0
Clinical outcomes: Bronchiectasis Exacerbations and Symptoms Tool (BEST) tool. Daily completion of BEST tool by both intervention and control group participants over 12mth recruitment period. Exacerbation will be classified by a 4-point rise in daily score
Timepoint [2] 410591 0
12mths after recruitment
Secondary outcome [3] 410592 0
Clinical Outcomes: Cough related QOL : Leicester Cough Questionnaire (LCQ) - intervention and control group participants
Timepoint [3] 410592 0
Baseline and 12mths after recruitment
Secondary outcome [4] 410593 0
Hospital admissions : via audit of patient records & monthly phone calls to intervention and control participants
Timepoint [4] 410593 0
12mths after recruitment
Secondary outcome [5] 410594 0
Adverse events : recorded by
1) Therapist providing intervention (recorded as part of fidelity checklist at each intervention & during physiotherapist telehealth session)
2) Monthly phone call by independent investigator of each intervention participant from
Timepoint [5] 410594 0
From recruitment over 12mths of intervention
Secondary outcome [6] 410595 0
Fidelity of intervention : sessions recorded and checked against fidelity checklist following each intervention
Timepoint [6] 410595 0
Following completion of intervention (4th telehealth session)

Eligibility
Key inclusion criteria
Adults aged over 18 diagnosed with bronchiectasis according to high resolution computed tomography (HRCT) who have access to the internet and video conferencing facilities and understand spoken and written English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Primary diagnosis of a respiratory condition other than bronchiectasis such as cystic fibrosis, chronic obstructive pulmonary disease (smoking history of greater than 10 years or evidence of emphysema on HRCT), asthma (clinical diagnosis and reversibility >12%) or interstitial lung disease.
Adults with bronchiectasis with an established relationship with a community-based or private practice physiotherapist for airway clearance therapy at the time of recruitment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To detect a difference in LCQ total score between groups following the intervention, 14 participants per group are required. This assumes a minimal important difference of 1.3 points in LCQ total score and a standard deviation of 3.8,37 (power of 80% and a significance level of p<0.05). Allowing for 20% attrition, 18 participants per group will be recruited.

Quantitative data will be presented using mean (SD) for normally distributed data or median (IQR) for non-normally distributed data. Differences between groups for the primary and secondary outcomes will be analysed using intention-to-treat principles, with comparisons undertaken using repeated measures analysis of variance. Comparisons of times to first recurrence of an exacerbation following baseline data collection over the 12 months will be analysed using Kaplan Meier survival curves. All analyses will be performed using SPSS V.26 (SPSS, Chicago, Illinois, USA). Alpha will be set at 0.05.

Qualitative Data: All participants will be provided with a study ID. Following transcription, interview transcripts will be stored and organised using a computer software program (QSR NVivo version 9, Doncaster). The interview transcripts will be independently examined by an investigator not involved with delivery of intervention. The transcripts will be first read line-by-line and fragmented into descriptive codes to represent data (open coding). Codes will then be organised hierarchically to form themes and the original transcripts will be searched to refine the relationship between themes and codes (axial coding).
The final themes will be agreed through iterative discussion between the two investigators. Direct quotes from participants will be extracted to support themes but will only be identified by a study ID. Data analysis will commence during the period that interviews will be conducted, so that preliminary analysis could inform the ongoing interview process. Data collection will continue until saturation is achieved.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/06/2022
Actual
15/09/2022
Date of last participant enrolment
Anticipated
31/01/2024
Actual
Date of last data collection
Anticipated
26/07/2024
Actual
Sample size
Target
36
Accrual to date
21
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21652 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 21653 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [3] 21654 0
Dandenong Hospital- Monash Health - Dandenong
Recruitment hospital [4] 21655 0
Casey Hospital - Berwick
Recruitment hospital [5] 26018 0
Eastern Health - Box Hill
Recruitment hospital [6] 26019 0
Maroondah Hospital - Ringwood East
Recruitment hospital [7] 26020 0
Angliss Hospital - Upper Ferntree Gully
Recruitment hospital [8] 26021 0
Healesville & District Hospital - Healesville
Recruitment postcode(s) [1] 36696 0
3168 - Clayton
Recruitment postcode(s) [2] 36697 0
3165 - East Bentleigh
Recruitment postcode(s) [3] 36698 0
3175 - Dandenong
Recruitment postcode(s) [4] 36699 0
3806 - Berwick
Recruitment postcode(s) [5] 41864 0
3128 - Box Hill
Recruitment postcode(s) [6] 41865 0
3135 - Ringwood East
Recruitment postcode(s) [7] 41866 0
3156 - Upper Ferntree Gully
Recruitment postcode(s) [8] 41867 0
3777 - Healesville

Funding & Sponsors
Funding source category [1] 310440 0
Hospital
Name [1] 310440 0
Monash Lung and Sleep Institute research grant / Monash Health
Country [1] 310440 0
Australia
Primary sponsor type
Individual
Name
Dr Annemarie Lee
Address
Monash University (Peninsula Campus : Faculty of Medicine, Nursing and Health Sciences)
Moorooduc Hwy,
Frankston
VIC 3199
Country
Australia
Secondary sponsor category [1] 311991 0
None
Name [1] 311991 0
Address [1] 311991 0
Country [1] 311991 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310079 0
Monash Health Human Research Ethics Low Risk Review Panel
Ethics committee address [1] 310079 0
Ethics committee country [1] 310079 0
Australia
Date submitted for ethics approval [1] 310079 0
19/01/2022
Approval date [1] 310079 0
23/03/2022
Ethics approval number [1] 310079 0
ERM Reference Number: HREC/76959/MonH-2022-297971(v1) Monash Health Reference: RES-22-0000038L
Ethics committee name [2] 310646 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 310646 0
Ethics committee country [2] 310646 0
Australia
Date submitted for ethics approval [2] 310646 0
25/03/2022
Approval date [2] 310646 0
25/03/2022
Ethics approval number [2] 310646 0
32424

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

Contacts
Principal investigator
Name 116406 0
Dr Annemarie Lee
Address 116406 0
School of Primary and Allied Health Care
Faculty of Medicine, Nursing and Health Science
Monash University
PO Box 527, Frankston, VIC, 3199
Country 116406 0
Australia
Phone 116406 0
+61 3 9904 4121
Fax 116406 0
Email 116406 0
[email protected]
Contact person for public queries
Name 116407 0
Annemarie Lee
Address 116407 0
School of Primary and Allied Health Care
Faculty of Medicine, Nursing and Health Science
Monash University
PO Box 527, Frankston, VIC, 3199
Country 116407 0
Australia
Phone 116407 0
+61 3 9904 4121
Fax 116407 0
Email 116407 0
[email protected]
Contact person for scientific queries
Name 116408 0
Annemarie Lee
Address 116408 0
School of Primary and Allied Health Care
Faculty of Medicine, Nursing and Health Science
Monash University
PO Box 527, Frankston, VIC, 3199
Country 116408 0
Australia
Phone 116408 0
+61 3 9904 4121
Fax 116408 0
Email 116408 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To comply with privacy laws, individual data is unable to be available, however group data will be available in presentations and publication.


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.