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Trial registered on ANZCTR


Registration number
ACTRN12614000525684
Ethics application status
Approved
Date submitted
28/11/2012
Date registered
16/05/2014
Date last updated
16/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
FAB study: Fan, Activity and Breathlessness: assessing the fan’s capacity to increase physical activity in patients with breathlessness and reducing carer anxiety
Scientific title
In people with intractable breathlessness, is a low or high speed hand held battery-operated fan with advice on management of breathlessness more effective than advice on management of breathlessness only in improving activity levels?
Secondary ID [1] 279931 0
Nil
Universal Trial Number (UTN)
Trial acronym
FAB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breathlessness 285842 0
Physical activity 285843 0
Self management 285857 0
Self-efficacy - care givers 285858 0
Condition category
Condition code
Respiratory 286023 286023 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be allocated to receive:

Fan A: a hand held, battery-operated fan that generates a low air flow rate and general advice about breathlessness management and exercise.; or

Fan B: a hand held, battery-operated fan that generates a high air flow rate (three bladed hand held battery operated Cooler Multi Function Personal Mini Fan by Design Go) and general advice about breathlessness management and exercise.

Intervention participants will be taught how to use the hand held battery operated fan in the context of general advice about breathlessness management and exercise.

Participants will be encouraged to use the fan when they feel breathless e.g. in relation to waking, exercise and other daily activities over the following 28 days.
Intervention code [1] 284256 0
Treatment: Devices
Comparator / control treatment
The control goup will be given information leaflets outlining practical advice on managing breathlessness including breathing control exercises, positions for recovery from breathlessness, advice about the importance of exercise and some simple exercises to try will be provided to all participants.
Control group
Active

Outcomes
Primary outcome [1] 286512 0
The primary outcome measure will be activity levels over 7 days, measured by the activPAL (Trademark) monitor.
Timepoint [1] 286512 0
Change in total physical activity over 7 days from prior to randomisation (Day -8 till Day 0) to Day 21-28 (the week prior to study end).
Secondary outcome [1] 296047 0
Changes in Function, as measured by 6 Minute Walk Test (6MWT) and Life-Space Assessment
Timepoint [1] 296047 0
Changes in function, at Baseline and Day 28.
Secondary outcome [2] 296051 0
Change in unpleasantness of breathlessness on a (0-10 numerical rating scale, 0 = none; 10 worst imaginable)
Timepoint [2] 296051 0
Symptom Assessment at Baseline, Day 7, 14, 21 and 28
Secondary outcome [3] 296052 0
Changes in patient self-efficacy as measured by COPD Self Efficacy Scale and General Self Efficacy Scale (GSES), Patient questionnaire regarding fan use
Timepoint [3] 296052 0
Patient self efficacy at Baseline and Day 28
Secondary outcome [4] 308091 0
Carer self efficacy and carer burden as measured by General Self Efficacy Scale and Zarit Care Giver Burden short form
Timepoint [4] 308091 0
Carer self efficacy and burden at Baseline and Day 28
Secondary outcome [5] 308092 0
Health Service Utilisation
Timepoint [5] 308092 0
Health Service Utilisation at Baseline, Day 7, Day 14, Day 21 and Day 28, recorded via patient verbal report and via patient medical records
Secondary outcome [6] 308195 0
Change in intensity of breathlessness (0-10 numerical rating scale, 0 = none; 10 worst imaginable)
Timepoint [6] 308195 0
Symptom assessment at Baseline, Day 7, Day 14, Day 21 and Day 28

Eligibility
Key inclusion criteria
Over 18

Able to provide verbal or written consent to take part in the study

Living in the community with or without a carer

Intractable breathlessness from all causes, for whom all reversible components of breathlessness have been addressed

Level 3 or higher on the modified Medical Research Council (mMRC) Dyspnoea scale; and

Have not used the hand held fan for breathlessness during the past week.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Too breathless to participate in study in the opinion of investigator and/or patient

Cognitively impaired and unable to understand the study

Medical Research Council (MRC) Dyspnoea scale < 3

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)
Potentially eligible participants will be approached by the patient’s usual clinician and referred to the study nurse or clinician investigator if agreeable to finding out more about the fan study. Potential participants will then be contacted by a member of the investigating team to discuss participation in the study. Eligibility will be assessed at this time and the potential participant provided with a participant information sheet. Case identification in outpatient and inpatient clinics will also occur with case note review.

In the UK the allocation of the randomisation codes will be held in the oncology clinical trials unit in Hull and in Australia these codes will be held in the Sacred Heart Clinical Trials Unit, in Darlinghurst, NSW.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated by block randomisation (1:1:2) to receive one of the three study arms. The Central Registry will be responsible for generating the block randomisation tables and will provide each site with the required number of randomisation sequence contained within sequentially numbered, opaque, sealed envelopes.


The allocation will be recorded on the schedule along with the date of allocation, and the participant ID number. On randomisation of a participant, the study nurse or trials unit manager at each centre will email a notification to the Australian coordinating site, using study number only. This notice will be monitored alongside the participant eligibility as entered onto the on-line data base from CRF A by the study nurse.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a feasibility study aiming to generate basic information on outcome estimates for powering the Phase III study no hypothesis will be tested. However, the following simple analyses will be conducted:
1. Descriptive analysis on recruitment per site per unit time
2.Descriptive analysis on the completion of endpoints
3.Comparison of ”fan” or “no fan” groups, irrespective of flow rate, with regard to activity as measured by the activPAL (Trademark) monitor.
4.To estimate the magnitude of outcome measures as well as to calculate the corresponding variance associated with these estimates.
5.Differences in the primary study outcome between the low flow and high flow fan groups.
6.Feasibility analysis regarding the percentage of people who completed all measures and study withdrawal rates.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/07/2012
Actual
11/03/2013
Date of last participant enrolment
Anticipated
30/03/2014
Actual
20/02/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 2412 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 8049 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 8050 0
5041 - Daw Park
Recruitment outside Australia
Country [1] 6033 0
United Kingdom
State/province [1] 6033 0
Hull UK
Country [2] 6046 0
United Kingdom
State/province [2] 6046 0
Scarborough

Funding & Sponsors
Funding source category [1] 284702 0
Other
Name [1] 284702 0
Sacred Heart Clinical Trials Unit, The Cunningham Centre for Palliative Care
Country [1] 284702 0
Australia
Primary sponsor type
University
Name
The University of Notre Dame Australia,
Address
160 Oxford Street Darlinghurst NSW 2010.
Country
Australia
Secondary sponsor category [1] 287844 0
Hospital
Name [1] 287844 0
Hull and East Yorkshire Hospitals NHS Trust
R&D Department
Address [1] 287844 0
Office 13, 2nd Floor Daisy Building, Castle Hill Hospital, Castle Rd, Cottingham, East Yorkshire HU16 5JQ. UNITED KINGDOM
Country [1] 287844 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286705 0
St Vincents Hospital Human Research and Ethics Committee
Ethics committee address [1] 286705 0
Level 6, de Lacy Building
St Vincents Hospital
390 Victoria Street,
Darlinghurst NSW 2010
Ethics committee country [1] 286705 0
Australia
Date submitted for ethics approval [1] 286705 0
23/11/2011
Approval date [1] 286705 0
04/06/2012
Ethics approval number [1] 286705 0
HREC/11/SVH/202

Summary
Brief summary
Many people live with the distress and difficulties arising from breathlessness which continues despite treatment of the disease which is causing it.
Exercise is known to be important and helpful for breathlessness, but the breathlessness itself, inevitably triggered by exertion, often puts people off persisting with this. Simple measures such as the use of a hand held battery operated fan to give cool airflow to the face can be helpful in easing breathlessness. The fan is cheap, easy to use and to carry around and something that both patient and their carer can manage, but it has never been assessed to see whether such a simple device could support people to exercise more as part of their daily routine. However, it is likely that in order to test this question, we will need a big study with several research teams who have an interest in the area working together.
This study is the first step in planning such a study involving colleagues in the UK and Australia. This first stage, therefore, is to see how we should set up such a study with regard to the following:
1. Will patient participants find the study we propose acceptable and practical?
2. What are the practicalities of working together with colleagues from the UK?
3. What number of participants would we need to make the full study able to answer our research question and is it possible to recruit sufficient numbers?
Trial website
Nil - at this stage
Trial related presentations / publications
Nil - at this stage
Public notes

Contacts
Principal investigator
Name 33770 0
Prof Jane Phillips
Address 33770 0
University of Notre Dame, Australia,
160 Oxford St,
Darlinghurst, NSW. 2010
Country 33770 0
Australia
Phone 33770 0
+ 61 41 1100 617
Fax 33770 0
+61 2 83829518
Email 33770 0
[email protected]
Contact person for public queries
Name 17017 0
Professor Jane Phillips
Address 17017 0
University of Notre Dame, Australia,
160 Oxford St,
Darlinghurst, NSW. 2010
Country 17017 0
Australia
Phone 17017 0
+61 2 04 11100 617
Fax 17017 0
+61 2 83829444
Email 17017 0
[email protected]
Contact person for scientific queries
Name 7945 0
Professor Jane Phillips
Address 7945 0
University of Notre Dame, Australia,
160 Oxford St,
Darlinghurst, NSW. 2010
Country 7945 0
Australia
Phone 7945 0
+61 2 04 11100 617
Fax 7945 0
+61 2 83829518
Email 7945 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseContributions of a hand-held fan to self-management of chronic breathlessness.2017https://dx.doi.org/10.1183/13993003.00262-2017
N.B. These documents automatically identified may not have been verified by the study sponsor.