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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
Date results information initially provided
2/03/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Handheld fan for breathlessness in interstitial lung disease
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Scientific title
Handheld fan for breathlessness in interstitial lung disease
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Secondary ID [1]
296735
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Interstitial Lung Disease
310602
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Condition category
Condition code
Respiratory
309316
309316
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
313043
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Treatment: Devices
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Comparator / control treatment
Without intervention (i.e. without handheld fan)
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Control group
Active
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Outcomes
Primary outcome [1]
308281
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Feasibility of the study design: Number of potential participants screened
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Assessment method [1]
308281
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Timepoint [1]
308281
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At the study conclusion (after completion of the final patient recruited for the study)
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Primary outcome [2]
308282
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Feasibility of the study design: Number of potential participants meeting the inclusion criteria
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Assessment method [2]
308282
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Timepoint [2]
308282
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At the study conclusion (after completion of the final patient recruited for the study)
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Primary outcome [3]
308283
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Feasibility of the study design: Number of participants recruited
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Assessment method [3]
308283
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Timepoint [3]
308283
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At the study conclusion (after completion of the final patient recruited for the study)
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Secondary outcome [1]
354505
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Feasibility of the study design: Number of participants randomised (Primary Outcome)
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Assessment method [1]
354505
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Timepoint [1]
354505
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At the study conclusion (after completion of the final patient recruited for the study)
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Secondary outcome [2]
354506
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Feasibility of the study design: Number and reasons of participants withdrawn using a study withdrawal survey either in-person or phone call (Primary Outcome)
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Assessment method [2]
354506
0
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Timepoint [2]
354506
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At the study conclusion (after completion of the final patient recruited for the study)
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Secondary outcome [3]
354507
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Feasibility of the study design: Proportion of missing data for outcome measures (Primary Outcome)
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Assessment method [3]
354507
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Timepoint [3]
354507
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At the study conclusion (after completion of the final patient recruited for the study)
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Secondary outcome [4]
354508
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Feasibility of the study design: Success of assessor blinding using the Bang's Blinding Index (Primary Outcome)
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Assessment method [4]
354508
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Timepoint [4]
354508
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At the study conclusion (after completion of the final patient recruited for the study)
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Secondary outcome [5]
354509
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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)
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Assessment method [5]
354509
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Timepoint [5]
354509
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At the study conclusion (after completion of the final patient recruited for the study)
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Secondary outcome [6]
354510
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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)
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Assessment method [6]
354510
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Timepoint [6]
354510
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At the study conclusion (after completion of the final patient recruited for the study)
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Secondary outcome [7]
354511
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Change in symptom from baseline: Dyspnoea-12 Questionnaire (Primary Outcome)
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Assessment method [7]
354511
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Timepoint [7]
354511
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2 weeks post treatment commencement
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Secondary outcome [8]
354512
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Participants’ perspectives on use of handheld fan for managing their symptoms using a semi-structured study completion interview (Primary Outcome)
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Assessment method [8]
354512
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Timepoint [8]
354512
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2 weeks post treatment commencement
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Secondary outcome [9]
354513
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Change in self-efficacy from baseline: Self-efficacy for Managing Chronic Disease 6-item Scale
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Assessment method [9]
354513
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Timepoint [9]
354513
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2 weeks post treatment commencement
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Secondary outcome [10]
354514
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Change in symptom from baseline: King's Brief Interstitial Lung Disease Questionnaire
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Assessment method [10]
354514
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Timepoint [10]
354514
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2 weeks post treatment commencement
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Secondary outcome [11]
354515
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Change in functional capacity from baseline: Manchester Respiratory Activities of Daily Living Questionnaire
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Assessment method [11]
354515
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Timepoint [11]
354515
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2 weeks post treatment commencement
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Secondary outcome [12]
354516
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Change in functional capacity from baseline: UAB Study of Aging Life-Space Assessment
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Assessment method [12]
354516
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Timepoint [12]
354516
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2 weeks post treatment commencement
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Secondary outcome [13]
354517
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Change in physical activity levels from baseline: SenseWear activity monitor
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Assessment method [13]
354517
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Timepoint [13]
354517
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2 weeks post treatment commencement
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Secondary outcome [14]
354518
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Usage of handheld fan based on participants’ report using a semi-structured study completion interview
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Assessment method [14]
354518
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Timepoint [14]
354518
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2 weeks post treatment commencement
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
This will be single-blinded study with the study assessor will be blinded to group allocation.
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Phase
Not Applicable
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Type of endpoint/s
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
14/01/2019
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Actual
11/02/2019
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Date of last participant enrolment
Anticipated
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Actual
6/02/2020
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Date of last data collection
Anticipated
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Actual
27/02/2020
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Sample size
Target
30
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Accrual to date
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Final
30
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
12593
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Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
24967
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3084 - Heidelberg
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Funding & Sponsors
Funding source category [1]
301315
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Charities/Societies/Foundations
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Name [1]
301315
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Institute for Breathing and Sleep
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Address [1]
301315
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145 Studley Road, Heidelberg, 3084 VIC
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Country [1]
301315
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Australia
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Funding source category [2]
302609
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Charities/Societies/Foundations
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Name [2]
302609
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Lung Foundation Australia
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Address [2]
302609
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Level 2, 11 Finchley St, Milton QLD 4064
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Country [2]
302609
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Australia
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Primary sponsor type
Individual
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Name
Dr Yet Hong Khor
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Address
Institute for Breathing and Sleep
Austin Health
145 Studley Road, Heidelberg, 3084 VIC
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Country
Australia
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Secondary sponsor category [1]
300981
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None
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Name [1]
300981
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Address [1]
300981
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Country [1]
300981
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302057
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Austin Human Research Ethics Committee
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Ethics committee address [1]
302057
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145 Studley Road, Heidelberg, 3084 VIC
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Ethics committee country [1]
302057
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Australia
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Date submitted for ethics approval [1]
302057
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28/09/2018
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Approval date [1]
302057
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28/11/2018
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Ethics approval number [1]
302057
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HREC/46012/Austin-2018
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
88978
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Dr Yet Hong Khor
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Address
88978
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Austin Health, 145 Studley Road, Heidelberg, 3084 VIC
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Country
88978
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Australia
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Phone
88978
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+61 39496 5000
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Fax
88978
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Email
88978
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[email protected]
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Contact person for public queries
Name
88979
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Dr Yet Hong Khor
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Address
88979
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Austin Health, 145 Studley Road, Heidelberg, 3084 VIC
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Country
88979
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Australia
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Phone
88979
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+61 39496 5000
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Fax
88979
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Email
88979
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[email protected]
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Contact person for scientific queries
Name
88980
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Dr Yet Hong Khor
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Address
88980
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Austin Health, 145 Studley Road, Heidelberg, 3084 VIC
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Country
88980
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Australia
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Phone
88980
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+61 39496 5000
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Fax
88980
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Email
88980
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
For privacy
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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.
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