Plain English Summary
Background and study aims
Cystic Fibrosis (CF) is an inherited disease affecting 10000 people in the UK with an average age at death of 28 years in 2012. The lungs of people with CF (PWCF) are prone to infections. Daily physiotherapy and inhaled medications are needed to stay healthy. Around £30 million is spent annually on inhaled therapy but average adherence has been shown to be only 36%. Data suggest that adherence is better in younger children but of the most of the PWCF are now adults. PWCF who collect less than 50% of their medication cost the healthcare system significantly more than PWCF who collect more than 80% and most of the additional cost results from unscheduled emergency care and hospital admission. This unscheduled emergency care is distressing for PWCF and their families. Current research investigating whether adult PWCF can build successful, self-management, treatment habits using dose-counting nebulisers to collect adherence data, displaying this data on a website (CFHealthHub) and using a behaviour change toolkit, supported by a health professional, is ongoing. The aim of this study and the CFHealthHub is to help facilitate quality improvement projects using data from CFHealthHub about participants adherence and participant's relationship with the team.
Who can participate?
Adults aged 16 and older who are diagnosed with CF and use a nebulizer.
What does the study involve?
Participants receive a new chipped nebuliser, or have their existing nebuliser adapted to communicate with CFHealthHub. They are given a log in to the CFHealthHub system and shown how to use their device and the CFHealthHub website, by a member of their care team. This includes how to turn on and off data sharing with their clinical team. Participants are then able to use their nebuliser as normal, with the support of CFHealthHub. CFHealthHub automatically collects data on the participants use of their chipped nebuliser, specifically the time of use and duration of inhalation. The data is stored in the secure CFHealthHub server. To provide a tailored CF toolkit participant's periodically complete a questionnaire about the challenges of taking their medication.
What are the possible benefits and risks of participating?
Participants may benefit from participating as the data could lead to changes in their CF care at their own health centre. Participants may find feedback available in the CFHealthHub useful to understand their condition or form habits to take their medication. Participants may benefit from the treatment or therapy offered. There are no notable risks with participants, however participants may have to give up some time to complete the consent visit.
Where is the study run from?
This study is being run by the University of Sheffield (UK) and takes place in three hospitals in the UK
When is the study starting and how long is it expected to run for?
January 2017 to March 2025
Who is funding the study?
NHS England CQUIN (UK)
Who is the main contact?
1. Mrs Kimberley Horspool
2. Dr Martin Wildman
Mrs Kimberley Horspool
Clinical Trials Research Unit
ScHARR (School of Health and Related Research)
University of Sheffield
30 Regent Street
+44 114 222 4348
Dr Martin Wildman
Honorary Senior Clinical Lecturer Health Services Research
Clinical Lead in Service Improvement
Consultant Respiratory Medicine & Adult CF
Sheffield Adult CF Centre
Northern General Hospital
CFHealthHub Data Observatory: A Quality Improvement project and Trials within Cohort platform for Cystic Fibrosis
The aim of CFHealthHub data observatory is to explore the use of adherence data for quality improvement and as behavioural data within a cohort for future CF studies.
London-Brent Research Ethics Committee, 06/04/2017, ref: 17/LO/0032
A pragmatic development study which consists of an observational cohort study and a platform for quality improvement projects across the NHS.
Primary study design
Secondary study design
Patient information sheet
Available to download from the study website https://www.sheffield.ac.uk/scharr/sections/dts/ctru/cfhealthhub/dataobservatory
CFHealthHub is an online portal which displays adherence data and provides behaviour change resources and tools for people with Cystic Fibrosis (PWCF), these tools used alongside trained CF health professionals support changes in patient self-management (nebuliser adherence). It is available on-line via computers, tablets or mobile phones. Previous research has focused on the development of an adherence intervention for PWCF (CFHealthHub) and is subject to ongoing evaluation. These work packages have been supported by an NIHR applied programme grants (Reference RP-PG-1212-20015).
The Data Observatory facilitates quality improvement projects, which act as an intervention within the CF team. These QI projects utilise the Clinical Microsystem methodology developed by the Dartmouth Institute, USA (Nelson, Bataldan and Godfrey 2007) and adopted by the Sheffield Microsystem Coaching Academy (MCA). The Sheffield MCA (http://www.sheffieldmca.org.uk) approach advocates that complex health systems can be reduced to smaller building blocks called ‘microsystems’ where multidisciplinary teams deliver healthcare to patients. At each microsystem a number of QI projects may occur but the implementation requires the completion of four phases; Assessment, Diagnose, Treatment and Standardise, where tools such as assessment using the 5 P’s (Purpose, Patients, Professionals, Processes, Patterns) process mapping, time series measurements, Plan Do Study Act (PDSA) cycles are utilised until the change idea has been adapted or has become embedded into the microsystem.
Participants who consent to take part in the study will receive a new chipped nebuliser, or have their existing nebuliser adapted to communicate with CFHealthHub. They will be given a log in to the CFHealthHub system and shown how to use their device and the CFHealthHub website, by a member of their care team. This includes how to turn on and off data sharing with their clinical team. Participants will then be able to use their nebuliser as normal, with the support of CFHealthHub.
CFHealthHub automatically collects data on the participants use of their chipped nebuliser, specifically the time of use and duration of inhalation. The data is stored in the secure CFHealthHub server.
To provide a tailored CF toolkit participant's periodically complete a questionnaire about the challenges of taking their medication, which is entered by a member of staff into CFHealthHub, at a clinic appointment or review.
Members of the CF team will be able to view the adherence data for participants who have data sharing switched on, and identify if any participants could benefit from the behavioural intervention that is currently being tested in an RCT. The Data Observatory will not be measuring the effectiveness of this intervention. Instead, CFHealthHub will help facilitate quality improvement projects using data from CFHealthHub about participants adherence and participant's relationship with the team.
Primary outcome measures
Sophisticated normative adherence as defined by Hoo (2016)
Secondary outcome measures
1. Unadjusted adherence is measured using adherence information stored in the CFHealthHub system
2. Simple normative adherence is measured using the CFHealthHub system
3. Process data (prescription checks, duration of inhalation) is measured using data recorded on CFHealthHub
4. The rate of consent as measured by the number of completed consent forms. Rate of follow up is measured by the number of completed follow-up questionnaires, data sharing is available by extracting the number of participants with data sharing switched on or off on the CFHealthHub system.
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Diagnosed with CF and with data within the CF registry
2. Aged 16 years and above
3. Taking inhaled mucolytics or antibiotics via a chipped nebuliser (e.g. eTrack or I-Neb) or able and willing to take via eTrack or I-Neb
Target number of participants
We hope to recruit 400 PWCF across 3 centres until 2019. When the RCT is completed in 2019 patients from the 20 RCT centres will be invited to join the data observatory with the possibility that all patients using nebulisers with electronic monitoring capabilities’ will eventually join the data observatory resulting in between 5000 to 6000 adults with CF included.
Participant exclusion criteria
Lacking in capacity to give informed consent
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Sheffield Teaching Hospital NHS Foundation Trust
Cystic Fibrosis Centre Northern General Hospital Herries Rd
Trial participating centre
Nottingham University Hospital NHS Trust
East Midlands Cystic Fibrosis Adult CF Centre Nottingham University Hospitals NHS Trust City Hospital campus Hucknall Road
Trial participating centre
University Hospital Southampton NHS Foundation Trust
Adult cystic fibrosis service level C, West Wing Southampton General Hospital Tremona Rd
NHS England CQUIN funding
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal. Additional documentation is available to download from the study website https://www.sheffield.ac.uk/scharr/sections/dts/ctru/cfhealthhub/dataobservatory
IPD sharing statement:
The data-sets generated during and/or analysed during the current study will be available upon request from Dr Martin Wildman (Chief Investigator), email@example.com. The data-sets are available throughout the duration of the Data Observatory. Data available will include real time adherence data. At present the study team are refining what information will be helpful for future research, therefore contacting the study team to discuss any requests is advised. Data will only be available from participants who have consented to participate in the trials within cohorts platform. All future research using the Data Observatory platform must be ethically approved. The Data Observatory is suitable for future randomised controlled trials. However, there are two levels of consent for the trials within cohorts platform, consent to:
1. Pseudonymised data within CFHealthHub to be used for future research related to CF which has been ethically approved
2. Be included for selection in future research studies which have been ethically approved. If the participant meets the desired characteristics for the study they may be selected by chance to receive a new treatment. If they are not selected to receive the new treatment then they consent to sharing pseudonymised data without further notification. If they are selected to receive the new treatment they understand that they will be contacted and will have the opportunity to decline participation in the new study.
Intention to publish date
Participant level data
Available on request
Results - basic reporting