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CFHealthHub Data Observatory

Details

Therapeutic category
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

Behavioral

Trial status

Open to recruitment

Participating Centres
Phase
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

Not Applicable

Full title

CF Health Hub Data Observatory: A quality improvement project and Trials Within Cohort platform for Cystic Fibrosis

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 four 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which may result in changes to care, such as testing new treatments.Consent in any combination can be provided and withdrawn at any time.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

95070

Trial type

Non-medication

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

Intervention
the name of the treatment or therapy being researched

Quality improvement projects

Recruitment target
the number of participants who need to be recruited for the trial in the UK

600

Last edited date

23 July 2020

CF sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

CF sponsor type

Academic

Who can take part?

Top inclusion criteria
  • Diagnosed with CF and with data within the CF registry
  • 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
  • Aged 16 years and above
Top exclusion criteria
  • Lacking in capacity to give informed consent

CF centres running this trial

Recruiting

Bristol Royal Infirmary

Address

Marlborough Street Bristol Avon BS2 8HW

Recruitment starts

June 2019

Recruitment ends

March 2025

Contact

Bateman, Kathryn

Get in touch

Recruiting

Frimley Park Hospital

Address

Portsmouth Road Frimley Camberley Surrey GU16 7UJ

Recruitment starts

December 2019

Recruitment ends

March 2024

Contact

Orchard, Chris

Get in touch

Recruiting

Glenfield Hospital

Address

Groby RoadLeicesterGroby RoadLeicestershire LE3 9QP

Recruitment starts

August 2019

Recruitment ends

March 2025

Contact

Ohri, Chandra

Get in touch

Recruiting

Nottingham University Hospitals NHS Trust

Address

Trust Headquarters City Hospital campus Hucknall Road Nottingham Nottinghamshire NG7 2UH

Recruitment starts

October 2017

Recruitment ends

March 2024

Contact

Barr, Helen

Get in touch
Show all participating centres