![](https://hhtu.hull.ac.uk/wp-content/uploads/2024/05/Picture1.png)
Study Design: Randomised Controlled Trial (Multicentre, parallel-group, open-label, randomised controlled, hybrid Type-I effectiveness-implementation feasibility study)
Disease Area: Respiratory
Funder: Research for Patient Benefit (RfPB)
Sponsor: Hull University Teaching Hospitals (HUTH)
Chief Investigator: Dr Michael G Crooks
Trial registration: ISRCTN36893888
Fan Feasibility Randomised Controlled Trial (RCT) for people living with COPD and high SABA intake (FanFIRST)
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Project overview
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Trial Team
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Participating Sites
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Patient Information
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Dissemination
Summary
Chronic obstructive pulmonary disease (COPD) is a lung disease that tends to affect older adults. Breathlessness is the most common symptom which greatly impairs quality of life. COPD is mainly treated using inhalers taken once-or-twice every day, but another type of inhaler, called a short-acting beta agonist (SABA), provides short-term symptom relief. SABA inhalers are only meant to be used when needed. However, people with COPD often don’t know how best to manage their breathlessness and can become reliant on their SABA, using it too frequently and risking side effects such as worse breathlessness, or increased likelihood of COPD ‘flare-ups’. We believe that teaching COPD patients how to use a hand-held-fan (HHF), and other techniques to manage their breathlessness (the FanFIRST intervention*), may improve their breathlessness and reduce how often they need their SABA. Furthermore, SABA inhalers contain a strong greenhouse gas that contributes to global warming. Therefore, reducing how many SABA inhalers are used each year has potential dual-benefits to both COPD patients and the environment. A large trial is needed to tell if the FanFIRST intervention can help people manage their breathlessness and reduce SABA inhaler use.
*The FanFIRST intervention takes about 10-minutes and includes providing a fan and teaching people how to use it, alongside guidance on positions and breathing techniques to help manage breathlessness. Written information about breathlessness and anxiety and how to manage this will also be provided.
However, before we start there are a number of questions which need to be answered. For example:
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- Can we recruit enough people to a trial?
- What sort of health services are best to recruit people from?
- Do people like the FanFIRST intervention?
- What do people with COPD (and their carers) think about the trial design, and the questions that it is designed to answer?
To answer these questions and more, we will first undertake a smaller study called a feasibility trial. The results of the feasibility study will tell us two important things. First, whether a larger trial is possible, and if so, how best to run it. Second, if provisional results are deemed effective, how best to roll-out the FanFIRST intervention across the NHS.
What we plan to do
During the feasibility trial, we aim to recruit 80 COPD patients that use their SABA inhaler frequently. Participants will be randomised to receive either the FanFIRST intervention, or usual care. All participants will be provided with sensors that attach to their SABA inhaler to record usage. Participants will complete a number of measures every 28 days, including measures of breathlessness, quality of life and healthcare contacts. Initial SABA usage e.g., at baseline, will be compared with usage between days 56 to 84.
We will also be conducting a sub-study which will recruit 20 participants randomised to the FanFIRST intervention (and their carers if
indicated) to take part in an interview with a researcher. In addition, 20 participants from a range of health care professions, involved in the delivery of the FanFIRST intervention will also be invited to take part in an interview with a researcher. These interviews will be used to explore participants and healthcare practitioners experiences of the study, the FanFIRST intervention, and whether there is a good indication of potential for scaled implementation across the NHS.
Chief Investigator
Dr Michael Crooks Professor of Respiratory Medicine, Clinical Lead for the Humber and North Yorkshire Respiratory Network - Hull University Teaching Hospitals
HHTU Study team
Saphsa Codling - Trial Manager
Judith Cohen - Director
Beccy Acaster - Data Manager
Sarah Sumpter - Senior Data Manager
Kerri Morris - Trial Administrator
Collaborators
Alex Wilkinson Respiratory Consultant, Clinical Lead for Respiratory Infection and TB East and North Hertfordshire NHS Trust
Email address
fanfirst@hyms.ac.uk
Participating Sites and their Project Investigators
Hull, Castle Hill Hospital - Dr Micheal Crooks
You can read the Patient information documents by clicking the links below.
Watch this space.
Collaborators
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