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CFHealthHub: Development and evaluation of an intervention to support adherence to treatment in adults with Cystic Fibrosis

ACtiF Study Team Photo

CTRU and ScHARR have been awarded a prestigious five-year programme grant by the NIHR (National Institute for Health Research) Programme Grants for Applied Research. ‘Develop and evaluate an intervention to support Adherence to treatment in adults with Cystic Fibrosis’.

The lead applicant (Chief Investigator), Dr Martin Wildman (Sheffield Teaching Hospitals) and joint lead applicant Professor Alicia O’Cathain (ScHARR) collaborated with a number of colleagues including those from ScHARR (Stephen Walters, Jon Nicholl, Daniel Hind, Paul Tappenden and Daniel Beever), Sheffield Hallam University and University of Manchester to win this £2 million grant.

The aim of the programme is to develop and evaluate a complex behaviour change intervention (BCI) to support medication adherence for adults with Cystic Fibrosis (CF). The BCI includes the development of a web portal, CFHealthHub, to capture adherence data from patients’ nebulisers and display this to clinicians and patients with CF (PWCF). CFHealthHub will facilitate a range of evidence-based interventions including problem solving and setting implementation plans to increase treatment adherence.

A number of distinct work packages, outlined below, aimed to develop, iterate and test the BCI. The table below outlines the progress made with each of the work packages to date.

You can also find out more about our longer-term work on adherence, called the 'Data Observatory', by clicking here.


Developing the intervention (month 1-14) and starting the Feasibility study (month 15-19)

Work package

Expected outcomes

Planned start and end date

Outcomes achieved

WP 1 Developing the CFHH platform via programming to produce a functional website and mobile application
March 2015 - April 2016
1.1 Adherence data capture programming to allow data capture from eFlow/iNeb and dry powders. March 2015 - July 2017
Initial developments of system complete prior to start of feasibility study. Ongoing iterations to continue through to July 17 before RCT starts.
• eTrack programming complete to allow use of eTracks in Pilot study
• iNeb programming and testing started Sept16
• dry powder device negotiations ongoing
1.2 Develop CFHH web interface and website with all components (1.2a) incorporating the iterative work conducted within WP 2.2B (1.2b) March 2015 – Jan 2016 CFHH programming for the full website including a “pretty” front end user interface developed and completed over 14 months. Work completed by 30 April 2016 ready for start of the Pilot study.
The work integrated feedback from participants recruited to WP2.2b(1) and 2.2b (see below).
WP 2 Developing the behaviour change intervention: CFHH manual and training
March 2015 - April 2016
2.1a Qualitative interviews to elicit treatment views and beliefs in patients with CF (PWCF) to feed into the development of CFHH. March 2015 – August 2015
First participant recruited: 22/03/2015
Start: 01/03/2015
End: 31/08/2015
(n=18)
COMPLETE
A qualitative interview study to understand factors influencing adherence to nebuliser medication in adults with Cystic Fibrosis. Semi structured interviews conducted with 18 PWCF. Feedback incorporated into development of the intervention and website.
2.2b(1) and 2.2b Early look at adherence data within CFHH and development (2.2b1) and subsequent iterative work with PWCF to refine the intervention (2.2b) ready for the Feasibility study. 2.2B(1) REC application
First participant recruited: 04/08/2015
Start: 04/05/2015
End: 31/01/2016 (n=5)
2.2B REC application
First participant recruited: 29/09/2015
Start: 01/09/2015
End: 01/04/2016 (n=22)
COMPLETE
A study to understand how to use the eTrack nebuliser and Qulacomm Hub to support people with CF (PWCF) to adhere to their nebuliser treatment and to develop and refine the behaviour change intervention (including CFHealthHub). All work was completed as scheduled prior to the start of the Feasibility study.
Completion of the development of the behaviour change intervention to support medication adherence with 27 participants (2.2b1 n=5, 2.2b n=22). The intervention includes data displays and a website, coproduced with patients. These components of the complex intervention are useable by, as well as acceptable and appropriate to PWCF.
2.1C To produce and develop talking heads videos for CFHealthhub. The videos will tell patient stories in relation to PWCF managing medication adherence and strategies they employ to help with this. REC application
First participant recruited: 18/11/2015
Start: 25/05/2015
End: 31/08/2017
(n=14)
COMPLETE
Development and evaluation of an intervention to support adherence to treatment in adults with Cystic Fibrosis: A sub study to record patient story videos for the behaviour change intervention. Participants described their personal experiences of using nebulisers for CF, what had motivated them to want to improve their adherence, and strategies that worked for them.
2.3/2.1b Development of the intervention manual, training programme, and assessment of fidelity for use in a pilot trial n/a COMPLETE
We have developed an intervention manual which provides instructions on how to use CFHH and the tools contained within in it. It also provides a structured intervention delivery procedure, and a reporting system that forms part of the assessment of the fidelity of intervention delivery. Alongside this manual we have developed a training programme consisting of face-to-face delivery, online learning, structured tutorial support and feedback.

Month 15 to 19
WP3.1 Feasibility study with embedded pilot trial
May 2016-April 2017
3.1 Feasibility study with embedded pilot trial starting May 2016.
• an ‘external pilot RCT’ to establish the feasibility of recruitment to a larger, definitive study; and,
• a ‘process evaluation’ which will help us understand the strengths and weaknesses of both the intervention and research protocols, and ways of addressing any weaknesses
May 2016 – April 2017
Recruitment: 13 Jun 16 to 30 Sep 16
ONGOING
Feasibility outcomes achieved
• n=64 participants randomised to date within the 16 week period therefore achieving the recruitment feasibility target
Process evaluation outcome to date
• n=4 interviews completed (2 with staff and 2 with PWCF)

Work-package 3.1
Following the development of the BCI, the programme moved to test the feasibility of conducting a larger scale trial. Recruitment to the pilot trial occurred in two CF units, across three NHS organisations. Participants were randomised to receive either: (1) CFHealthHub (CFHH) – a complex intervention based on Social Cognitive Theory and Control Theory. CFHH links collection and systematic feedback of adherence data via a chipped nebuliser (eTrack) and software platform, with strategies to empower self-management delivered online and in six face-to-face meetings over 5m with trained interventionists (n=32); (2) usual care, typically face-to-face meetings every 3m with CF team (n=32). The objectives of the pilot trial were to determine whether a full scale trial was feasible in terms of recruitment and retention; test the acceptability of CFHH; and, test the procedures for a full-scale trial. The pilot trial also involved qualitative data collection from the initial intervention sessions, control arm consultations and semi structured interviews with participants in the intervention arm, control arm and interventionists. The stop-go criterion was met with 64 participants being recruited in the allocated recruitment window. The interventionists are now conducting intervention sessions and the first 5 month follow up visits are due to commence in November 2016. The main trial is feasible based on recruitment to the pilot trial between May and September 2016. Currently the retention rates and intervention acceptability are still under review.


CFHealthHub recruitment graph


This project is funded by the NIHR's Programme Grants for Applied Research.

Study Staff:

Name Role Organisation Contact
Dr Martin Wildman Chief Investigator Sheffield Teaching Hospitals NHS Foundation Trust martin.wildman@sth.nhs.uk
Professor Alicia O'Cathain Chief Investigator University of Sheffield a.ocathain@sheffield.ac.uk
Marlene Hutchings Research Physiotherapist Sheffield Teaching Hospitals NHS Foundation Trust marlene.hutchings@sth.nhs.uk
Professor Maddy Arden Behaviour Change Intervention Lead Sheffield Hallam University m.arden@shu.ac.uk
Chin Maguire Project Manager University of Sheffield c.maguire@sheffield.ac.uk
Hannah Cantrill Research Assistant University of Sheffield h.cantrill@sheffield.ac.uk
Helen Wakefield Trials Support Officer University of Sheffield h.wakefield@sheffield.ac.uk
Dr Daniel Hind CTRU oversight University of Sheffield d.hind@sheffield.ac.uk
Dan Beever Person with CF, PPI Lead University of Sheffield d.a.beever@sheffield.ac.uk
Dr Sarah Drabble Qualitative Lead University of Sheffield S.J.Drabble@sheffield.ac.uk
Professor Judy Bradley Professor of Physiotherapy and Health Services Research University of Ulster judy.bradley@qub.ac.uk
Dr Pauline Whelan Lead Software Developer/mHealth Applications Manager University of Manchester pauline.whelan@manchester.ac.uk
Ricardo Ortega Website Designer Keep It Usable ricardo@keepitusable.com
Susan Kirkpatrick Senior Qualitative Researcher University of Oxford susan.kirkpatrick@phc.ox.ac.uk

Co-applicants:

Name Position Institution
Dr John Ainsworth Senior Research Fellow The Farr Institute of Health Informatics Research, University of Manchester
Professor Iain Buchan Clinical Professor in Public Health Informatics The Farr Institute of Health Informatics Research, University of Manchester
Professor Stuart Elborn Consultant Physician, Respiratory Medicine Belfast Health and Social Care Trust
Professor Rachel Elliott Lord Trent Professor of Medicines and Health The University of Nottingham
Marie McKenniff Operations Director, Sheffield Teaching Hospitals Sheffield Teaching Hospitals NHS Foundation Trust
Professor Susan Michie Professor of Health Psychology University College London
Professor Mohammed A Mohammed Professor of Quality and Effectiveness University of Bradford
Professor Jon Nicholl Dean of School (ScHARR) ScHARR, The University of Sheffield
Dr Paul Tappenden Reader in Health Economic Modelling ScHARR, The University of Sheffield
Professor Stephen Walters Professor of Medical Statistics and Clinical Trials ScHARR, The University of Sheffield