Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000649718
Ethics application status
Approved
Date submitted
20/04/2022
Date registered
3/05/2022
Date last updated
25/04/2024
Date data sharing statement initially provided
3/05/2022
Date results information initially provided
12/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Self-management package for people with pulmonary fibrosis: a study to determine feasibility and acceptability
Scientific title
Self-management package for pulmonary fibrosis: a feasibility study
Secondary ID [1] 306730 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary fibrosis 325722 0
Condition category
Condition code
Respiratory 323062 323062 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Use of self-management package with support from health professional

A self-management package developed by the research team will be provided to the participants as part of the intervention. Participants can choose to receive an electronic (i.e., PDF format) or hardcopy of the package.

The purpose of the package is to facilitate effective self-management in people with pulmonary fibrosis (PF), by providing access to reliable information and resources that empowers them with the knowledge, skills and confidence to take an active role in the management of their lung disease.

This package includes 12 modules that were considered essential for self-management in PF in a previous Delphi study. These modules cover areas such as managing symptoms, co-existing medical conditions and medications; understanding treatment options and clinical trials; role of oxygen therapy, pulmonary rehabilitation and regular physical activity; smoking cessation advice and support; accessing community support; and how to communicate with others when living with the disease.

Each module provides key information regarding the topic and provides access to external online information relevant to the topic including websites, fact sheets, booklets, videos and webinars. These external resources have been verified by the research team as reliable, current, and relevant resources to support people with PF in self-management. Participants will have direct access to these external resources from within the package through hyperlinks embedded in the title of each resource. Participants do not have to view all external resources listed in the module, they can choose the ones that are relevant to them. Depending on the number of external resources that the participant views, the estimated time required to complete a module is approximately 30 minutes to 3 hours.

In addition, this package provides guidance for participants to set personal goals for managing their health and includes a symptom diary for participants to document their symptoms.

Participants who receive an electronic or hardcopy of the package can read the package anywhere that suits them. Participants who do not have computer or internet access will be guided to use other methods such as using a mobile phone or a computer at a local library, or seeking assistance from family or friends to access the online external resources. These participants will also be offered an opportunity to use a tablet provided by the research team that can be accessed at the Alfred Centre in Melbourne, Australia.

A health professional specialised in PF care will provide support to each participant via telephone or telehealth 5 times over the 8-week intervention period, at week 1, 2, 3, 4 and 8 following randomisation. The aim of this support is to facilitate the effective use of the self-management package.

Depending on the participant’s needs, the health professional may provide guidance or assistance in identifying appropriate modules, setting and achieving health-related goals, monitoring progress, assisting with addressing possible challenges and to provide feedback or clinical recommendations throughout the 8-week intervention period.

Adherence to completing the module/s and reaching a health-related goal (if the participant has set a goal) will be monitored and documented by the health professional conducting the calls, on the study-specific telephone call record sheet.

Each session is expected to last approximately 15-30 minutes. Attendance at each of the 5 sessions, the duration of each call and the type of support provided will be documented for each session using the telephone call record sheet.

During session 1: At one week following randomisation, a health professional will support the participant in identifying the appropriate modules to access, setting a goal and building a plan to reach that. All participants in the intervention group will be encouraged to set at least one goal and choose at least one module to read throughout the 8-week intervention period.

During session 2 to 5: At weeks 2, 3, 4, and 8 following randomisation, a health professional will discuss with the participant their progress on their chosen module/s and goal plan (if they have one), their confidence in reaching the goal and managing their health, and provide feedback and clinical recommendations where appropriate.
Intervention code [1] 323177 0
Behaviour
Intervention code [2] 323178 0
Lifestyle
Intervention code [3] 323446 0
Treatment: Other
Comparator / control treatment
Participants randomised to the control group will be directed to the Lung Foundation Australia’s website (https://lungfoundation.com.au/resources/?condition=23&user_category=31) where they can access standardised information on PF.

To control for the effects of attention, participants in the control group will receive calls at the same frequency as the intervention group (at week 1, 2, 3, 4 & 8 following randomisation) via the telephone or Zoom depending on their preference. These calls will be general in nature and will be conducted by a researcher working in PF. No health advice will be provided during any of the sessions, with participants directed to their usual health professionals if health advice is needed.

The duration of each call will be recorded and is estimated at approximately 15-30 minutes, based on the discretion of the participant.
Control group
Active

Outcomes
Primary outcome [1] 330830 0
The proportion of eligible participants recruited - assessed by audit of study database
(feasibility is defined as - recruitment of at least 25% of those who meet the eligibility criteria)
Timepoint [1] 330830 0
At study completion
Primary outcome [2] 330831 0
The proportion of recruited participants who are randomised - assessed by audit of study database
(feasibility is defined as - randomisation of at least 80% of those who are recruited)
Timepoint [2] 330831 0
At study completion
Primary outcome [3] 331196 0
The proportion of participants completing baseline and post-intervention assessments - assessed by audit of study database
(feasibility is defined as - at least 80% of participants completing both baseline and post-intervention assessments)
Timepoint [3] 331196 0
At study completion
Secondary outcome [1] 407761 0
Change in self-efficacy - assessed using the General Self-efficacy Scale
Timepoint [1] 407761 0
Prior to randomisation; 8 weeks post-intervention commencement
Secondary outcome [2] 407762 0
Change in health-related quality of life - assessed using the King’s Brief Interstitial Lung Disease questionnaire
Timepoint [2] 407762 0
Prior to randomisation; 8 weeks post-intervention commencement
Secondary outcome [3] 407763 0
Change in dyspnoea - assessed using the Modified Medical Research Council dyspnoea scale
Timepoint [3] 407763 0
Prior to randomisation; 8 weeks post-intervention commencement
Secondary outcome [4] 407764 0
Change in 7-day physical activity level (steps per day) - measured using an ankle-worn STEPWatch activity monitor
Timepoint [4] 407764 0
7 days prior to randomisation; 7 days following completion of intervention
Secondary outcome [5] 407765 0
New treatments or changes to treatments for PF - by medical records review
Timepoint [5] 407765 0
8 weeks post-intervention commencement
Secondary outcome [6] 407767 0
Health care ultilisation during the study period - assessed as a composite of medical record review and patient self-report during the 8th week post-intervention commencement follow-up telephone call with a health professional
Timepoint [6] 407767 0
8 weeks post-intervention commencement
Secondary outcome [7] 409140 0
Additional primary outcome

The proportion of participants accessing a minimum of one module - assessed by audit of the telephone call record sheets
(acceptability is defined as - at least 80% of participants in the intervention group accessing a minimum of one module)
Timepoint [7] 409140 0
At study completion
Secondary outcome [8] 409141 0
Additional primary outcome

The proportion of participants setting at least one goal - assessed by audit of the telephone call record sheets
(acceptability is defined as - at least 30% setting one goal)
Timepoint [8] 409141 0
At study completion
Secondary outcome [9] 409142 0
Change in health-related quality of life - assessed using the EQ-5D-5L questionnaire
Timepoint [9] 409142 0
Prior to randomisation; 8 weeks post-intervention commencement

Eligibility
Key inclusion criteria
This study will include people aged 18 years and over with a physician confirmed diagnosis of fibrotic interstitial lung disease (ILD) (including both idiopathic pulmonary fibrosis (IPF) and non-IPF diagnoses), and able to consent to participate in the study. As the self-management package is designed in English, participants must be able to read written English or have someone reading the package for them in their preferred language. They must also be able to communicate in English as all telephone sessions will be conducted in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
This study will exclude people with PF who are unable to provide consent due to cognitive impairment or for other reasons.

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)
Participant group allocation will be concealed and stored using a password protected file accessible to only researchers involved in the study who are not required to be blinded to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using randomisation table created by computer software
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
Statistical methods / analysis
It is estimated that a sample size of 30 (15 in intervention group and 15 in control group) would be sufficient to cover a range of participants with various characteristics and to inform the feasibility and acceptability of the intervention. This is based on a previous study investigating feasibility of a non-pharmacological intervention in people with an ILD which was conducted successfully using a similar sample size.

Descriptive analysis of data will be performed using SPSS statistical analysis software. Feasibility and acceptability outcome measures will be reported as numbers of participants and percentages. All secondary outcome measures data will be analysed based on the intention-to-treat principle. The STEPWatch software will be used to retrieve data collected on the device. The device will show steps per day in a 7-day period. Five out of the seven days of data will be used for analysis, the first and last 24 hours of the activity recording data will be discarded. An average steps per day over 5 days will be calculated. The differences in measures of physical activity between baseline and completion of intervention stratified by randomised groups, will be compared by performing t-tests (for parametric data), and Mann-Whitney tests or Wilcoxon Signed-Rank tests (for non-parametric data).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/05/2022
Actual
7/06/2022
Date of last participant enrolment
Anticipated
27/01/2023
Actual
23/03/2023
Date of last data collection
Anticipated
30/06/2023
Actual
30/06/2023
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22000 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 37103 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 311061 0
University
Name [1] 311061 0
Monash University
Country [1] 311061 0
Australia
Funding source category [2] 311066 0
Charities/Societies/Foundations
Name [2] 311066 0
Lung Foundation Australia
Country [2] 311066 0
Australia
Primary sponsor type
University
Name
Monash University
Address
First floor, 24 Sports Walk
Monash University, Clayton Campus
Clayton
VIC 3800
Country
Australia
Secondary sponsor category [1] 312402 0
None
Name [1] 312402 0
Address [1] 312402 0
Country [1] 312402 0
Other collaborator category [1] 282226 0
Hospital
Name [1] 282226 0
The Alfred
Address [1] 282226 0
55 Commercial Road
Melbourne
VIC 3004
Country [1] 282226 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310606 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 310606 0
55 Commercial Road
Melbourne
VIC 3004
Ethics committee country [1] 310606 0
Australia
Date submitted for ethics approval [1] 310606 0
Approval date [1] 310606 0
02/03/2022
Ethics approval number [1] 310606 0
39/22
Ethics committee name [2] 310610 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 310610 0
First floor, 26 Sports Walk
Monash University, Clayton Campus
Clayton
VIC 3800
Ethics committee country [2] 310610 0
Australia
Date submitted for ethics approval [2] 310610 0
Approval date [2] 310610 0
15/03/2022
Ethics approval number [2] 310610 0
32211

Summary
Brief summary
This project's primary aim is to test the feasibility and acceptability of a self-management package that was specifically designed to support people with PF. The secondary aim is to collect preliminary data on clinical outcomes of using the self-management package, which include self-efficacy, health-related quality of life, dyspnoea, physical activity level, treatments for PF, and health care ultilisation.
The outcome measures will be compared between two groups: the intervention group (which receives the PF self-management package and support to facilitate the use of the package); and the control group (which receives standardised information about PF and attention control calls).
It is a randomised controlled trial that will help to determine the feasibility and acceptability to deliver the self-management package using the current study protocol. In addition, it will provide preliminary data that will inform larger trials in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118242 0
Prof Anne Holland
Address 118242 0
Level 6
The Alfred Centre
99 Commercial Road
Melbourne
VIC 3004
Country 118242 0
Australia
Phone 118242 0
+613 99030214
Fax 118242 0
Email 118242 0
Anne.Holland@monash.edu
Contact person for public queries
Name 118243 0
Prof Anne Holland
Address 118243 0
Level 6
The Alfred Centre
99 Commercial Road
Melbourne
VIC 3004
Country 118243 0
Australia
Phone 118243 0
+613 99030214
Fax 118243 0
Email 118243 0
Anne.Holland@monash.edu
Contact person for scientific queries
Name 118244 0
Prof Anne Holland
Address 118244 0
Level 6
The Alfred Centre
99 Commercial Road
Melbourne
VIC 3004
Country 118244 0
Australia
Phone 118244 0
+613 99030214
Fax 118244 0
Email 118244 0
Anne.Holland@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only group results will be presented or published.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15479Ethical approval  Anne.Holland@monash.edu



Results publications and other study-related documents

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Documents added automatically
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