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Trial registered on ANZCTR


Registration number
ACTRN12618001949279
Ethics application status
Approved
Date submitted
29/11/2018
Date registered
30/11/2018
Date last updated
2/03/2020
Date data sharing statement initially provided
30/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Handheld fan for breathlessness in interstitial lung disease
Scientific title
Handheld fan for breathlessness in interstitial lung disease
Secondary ID [1] 296735 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Interstitial Lung Disease 310602 0
Condition category
Condition code
Respiratory 309316 309316 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to use a handheld fan for symptom management. They will be provided the fan for use at home and in the community as needed for 2 weeks. There is no specific prescription for the frequency or duration of use. Participants can use the device as much or as little as they choose. Therapy usage will be monitored using a 7-day usage diary prior to each visit and the number of operated hours of portable concentrators.
Intervention code [1] 313043 0
Treatment: Devices
Comparator / control treatment
Without intervention (i.e. without handheld fan)
Control group
Active

Outcomes
Primary outcome [1] 308281 0
Feasibility of the study design: Number of potential participants screened
Timepoint [1] 308281 0
At the study conclusion (after completion of the final patient recruited for the study)
Primary outcome [2] 308282 0
Feasibility of the study design: Number of potential participants meeting the inclusion criteria
Timepoint [2] 308282 0
At the study conclusion (after completion of the final patient recruited for the study)
Primary outcome [3] 308283 0
Feasibility of the study design: Number of participants recruited
Timepoint [3] 308283 0
At the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [1] 354505 0
Feasibility of the study design: Number of participants randomised (Primary Outcome)
Timepoint [1] 354505 0
At the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [2] 354506 0
Feasibility of the study design: Number and reasons of participants withdrawn using a study withdrawal survey either in-person or phone call (Primary Outcome)
Timepoint [2] 354506 0
At the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [3] 354507 0
Feasibility of the study design: Proportion of missing data for outcome measures (Primary Outcome)
Timepoint [3] 354507 0
At the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [4] 354508 0
Feasibility of the study design: Success of assessor blinding using the Bang's Blinding Index (Primary Outcome)
Timepoint [4] 354508 0
At the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [5] 354509 0
Feasibility of the study design: Number of participants who elect to either continue or start using a handheld fan at the end of the trial (Primary Outcome)
Timepoint [5] 354509 0
At the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [6] 354510 0
Feasibility of the study design: Number of participants in each group who would recommend participating in this trial to others in a similar situation to themselves using a semi-structured study completion interview (Primary Outcome)
Timepoint [6] 354510 0
At the study conclusion (after completion of the final patient recruited for the study)
Secondary outcome [7] 354511 0
Change in symptom from baseline: Dyspnoea-12 Questionnaire (Primary Outcome)
Timepoint [7] 354511 0
2 weeks post treatment commencement
Secondary outcome [8] 354512 0
Participants’ perspectives on use of handheld fan for managing their symptoms using a semi-structured study completion interview (Primary Outcome)
Timepoint [8] 354512 0
2 weeks post treatment commencement
Secondary outcome [9] 354513 0
Change in self-efficacy from baseline: Self-efficacy for Managing Chronic Disease 6-item Scale
Timepoint [9] 354513 0
2 weeks post treatment commencement
Secondary outcome [10] 354514 0
Change in symptom from baseline: King's Brief Interstitial Lung Disease Questionnaire
Timepoint [10] 354514 0
2 weeks post treatment commencement
Secondary outcome [11] 354515 0
Change in functional capacity from baseline: Manchester Respiratory Activities of Daily Living Questionnaire
Timepoint [11] 354515 0
2 weeks post treatment commencement
Secondary outcome [12] 354516 0
Change in functional capacity from baseline: UAB Study of Aging Life-Space Assessment
Timepoint [12] 354516 0
2 weeks post treatment commencement
Secondary outcome [13] 354517 0
Change in physical activity levels from baseline: SenseWear activity monitor
Timepoint [13] 354517 0
2 weeks post treatment commencement
Secondary outcome [14] 354518 0
Usage of handheld fan based on participants’ report using a semi-structured study completion interview
Timepoint [14] 354518 0
2 weeks post treatment commencement

Eligibility
Key inclusion criteria
• Age of 18 years or older
• Able to give written informed consent
• Diagnosis of fibrotic interstitial lung disease of any aetiology
• Modified Medical Research Council Dyspnoea Scale greater than or equal to 2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Significant communication or locomotor difficulties
• Significant co-existing chronic obstructive pulmonary disease (defined as FEV1/FVC <60% on the most recent lung spirometry or extent of emphysema greater than extent of fibrosis on the most recent CT chest)
• Unstable health condition (defined as hospitalisation for acute medical conditions) in the last 4 weeks before screening

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
This will be single-blinded study with the study assessor will be blinded to group allocation.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Level of statistical significance will be set at p = 0.05. For comparisons of two groups, t-tests or Mann-Whitney tests will be used for parametric and non-parametric data, respectively. Percentages will be calculated for categorical variables. The Chi-Square Fisher’s Exact test will be used to compare the frequencies between different groups. The Bang’s Blinding Index will be used for blinding assessment. The interview will be transcribed verbatim into word documents. Methodological principles of grounded theory will underpin analysis of the transcripts. The transcripts will be analyzed initially using open coding, where they will be read line-by-line and fragmented into descriptive codes to represent the data. Codes will then be organized hierarchically to form themes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/01/2019
Actual
11/02/2019
Date of last participant enrolment
Anticipated
Actual
6/02/2020
Date of last data collection
Anticipated
Actual
27/02/2020
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12593 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 24967 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 301315 0
Charities/Societies/Foundations
Name [1] 301315 0
Institute for Breathing and Sleep
Country [1] 301315 0
Australia
Funding source category [2] 302609 0
Charities/Societies/Foundations
Name [2] 302609 0
Lung Foundation Australia
Country [2] 302609 0
Australia
Primary sponsor type
Individual
Name
Dr Yet Hong Khor
Address
Institute for Breathing and Sleep
Austin Health
145 Studley Road, Heidelberg, 3084 VIC
Country
Australia
Secondary sponsor category [1] 300981 0
None
Name [1] 300981 0
Address [1] 300981 0
Country [1] 300981 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302057 0
Austin Human Research Ethics Committee
Ethics committee address [1] 302057 0
145 Studley Road, Heidelberg, 3084 VIC
Ethics committee country [1] 302057 0
Australia
Date submitted for ethics approval [1] 302057 0
28/09/2018
Approval date [1] 302057 0
28/11/2018
Ethics approval number [1] 302057 0
HREC/46012/Austin-2018

Summary
Brief summary
People with interstitial lung disease often have poor quality of life because of distressing breathlessness and reduced exercise tolerance. Their survival is often poor and there are limited medical treatments available. There is no proven treatment for relieving symptoms in patients with these conditions. Handheld fans have been shown to be a useful intervention for breathlessness in patients with other lung conditions and cancers. This study aims to explore the use of a handheld fan, a simple and easily portable device, for symptom management in people with interstitial lung disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88978 0
Dr Yet Hong Khor
Address 88978 0
Austin Health, 145 Studley Road, Heidelberg, 3084 VIC
Country 88978 0
Australia
Phone 88978 0
+61 39496 5000
Fax 88978 0
Email 88978 0
[email protected]
Contact person for public queries
Name 88979 0
Yet Hong Khor
Address 88979 0
Austin Health, 145 Studley Road, Heidelberg, 3084 VIC
Country 88979 0
Australia
Phone 88979 0
+61 39496 5000
Fax 88979 0
Email 88979 0
[email protected]
Contact person for scientific queries
Name 88980 0
Yet Hong Khor
Address 88980 0
Austin Health, 145 Studley Road, Heidelberg, 3084 VIC
Country 88980 0
Australia
Phone 88980 0
+61 39496 5000
Fax 88980 0
Email 88980 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
For privacy


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.