the type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise
the different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use
CFHealthHub Data Observatory: A quality improvement project and Trials Within Cohort platform for Cystic Fibrosis
Cystic Fibrosis (CF) affects 10000 people in the UK. The lungs of people with CF (PWCF) are prone to infections and require daily medication to stay healthy. Average adherence to medication has shown to be only 36%. Poor adherence is associated with poor clinical outcomes including distressing unscheduled hospitalisations. Previous research has been undertaken to design a website (CFHealthhub) which records personal adherence data using chipped nebulisers and understand whether this can build successful treatment habits.
In the current project we will develop CFHealthHub as a data observatory which will record adherence data and other indicators of health and patient care held in patient notes. The purpose of this is two- fold; to support local and national Quality Improvement (QI) projects aiming to improve an individual’s adherence to treatment and the quality of care delivered by the CF centre. Secondly, collecting adherence data from a large number of PWCF may support future research studies whereby CFHealthHub is used as a source of participants and data.
We aim to recruit PWCF who use chipped nebulisers from 4 CF centres across in England. PWCF will be consented to 1) share their identifiable data with their local CF team 2) share data, from which they cannot be identified, with all CF centres in the study 3) share data, from which they cannot be identified, in future research studies which result in no changes to their care and 4) share data to be included for selection to future studies which may result in changes to care, such as testing new treatments.
Consent in any combination can be provided and withdrawn at any time. Participants who consent to 'selection' for future studies will also be provided with information specific to the new study and the opportunity to decline participation, if selected from the data observatory.
Trial Reference Number
Add to watchlist
Length of participation
the length of time a participant will take part in a trial, from the first to the last appointment
Up to 6 years
the name of the treatment or therapy being researched
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.
the number of participants who need to be recruited for the trial in the UK
Last edited date
07 September 2018
Sheffield Teaching Hospitals NHS Foundation Trust
CF sponsor type