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ACtiF - RCT and parallel process evaluation (WP 3.2 and 3.3)

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

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

Development and evaluation of an intervention to support Adherence to treatment in adults with 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 been shown to be only 36%. Poor adherence is associated with poor clinical outcomes including distressing unscheduled hospitalisations. We have designed an intervention that will feedback adherence data to PWCF using chipped nebulisers displaying real time treatment use on smartphones and the website (CFHealthhub). Feedback is a powerful support to habit formation and the interventionist will use CFHealthHub and a behaviour change manual to support PWCF in building successful treatment habits. This work package follows on from a successful Pilot and Feasibility (WP 3.1) study that successfully met the recruitment target to deem the main RCT feasible. This was based on recruiting 64 PWCF over four months at two CF centres (across three NHS Trusts) between June and September 2016. For this main RCT we aim to recruit PWCF for seven months at up to 20 CF units. We intend to recruit 688 PWCF overall. A computer will decide whether people who consent to be in the study will receive usual care alone or also receive the intervention. Both groups have a short period of two to four weeks when data is collected through their nebulisers and fed back to the website. It is only after that period that those allocated to the intervention are allowed to use the website and receive enhanced care from the interventionist. After that point, all participants are followed up for 12 months. Participants will complete a series of questionnaires at the outset and at 12 months.

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

12 months

Intervention
The name of the treatment or therapy being researched

complex intervention or usual care.

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

688

Last edited date

18 September 2017

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Sponsor type

Academic

Who can take part?

Top inclusion criteria
  • Diagnosed with CF and within CF registry
  • Aged 16 years and above
  • Willing and able to taking inhaled mucolytics or antibiotics via a chipped nebuliser (e.g. eTrack or bi-Neb)
Top exclusion criteria
  • Post-lung transplant or People on the active lung transplant list
  • Participants using dry powder devices to take antibiotics or mucolytics
  • Participants who lack capacity to give informed consent

CF centres running this trial

Recruiting

Heart of England NHS Foundation Trust

Address

Birmingham Heartlands Hospital Bordesley Green East Birmingham West Midlands B9 5SS

Recruitment starts

September 2017

Recruitment ends

April 2018

Contact

Nash, Edward

Get in touch

Recruiting

King's College Hospital NHS Foundation Trust

Address

Denmark Hill London Greater London SE5 9RS

Recruitment starts

September 2017

Recruitment ends

December 2019

Contact

Elston, Caroline

Get in touch

Recruiting

Royal Brompton and Harefield NHS Foundation Trust

Address

Royal Brompton Hospital Sydney Street London Greater London SW3 6NP

Recruitment starts

October 2017

Recruitment ends

April 2018

Contact

Elborn, Stuart

Get in touch

Recruiting

University Hospital of North Midlands NHS Trust (Royal Stoke)

Address

Royal Stoke University Hospital Hartshill Stoke on Trent Staffordshire ST4 6QG

Recruitment starts

September 2017

Recruitment ends

April 2018

Contact

McGowan , Angela

Get in touch
Show all participating centres