|
|
 |
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), conducting the Feasibility study (month 15-19), and the RCT
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 | |||
| WP 3 | 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 |
COMPLETE
|
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 conducted intervention sessions during the follow up period and completed the research follow up visits 5 months after entry into the study. The main trial is feasible based on recruitment to the pilot trial between May and September 2016, and participant retention and study procedures were satisfactory.
Work-package 3.2
Following the successful pilot trial, a large scale RCT is currently being conducted. The aim of this 19 centre RCT is to determine whether the complex intervention is more effective than standard care in improving outcomes for PWCF and to determine the best way to deliver the intervention. As with the pilot trial, participants were randomised to receive either: (1) CFHealthHub (CFHH) – a complex intervention (n=308); (2) usual care, typically face-to-face meetings every 3m with CF team (n=300). The objectives of the RCT are to determine the effect of the intervention on both clinical and participant related outcomes. In addition a process evaluation is underway which will facilitate interpretation of the RCT results and offer insights about how best to deliver the intervention in the real world. The RCT involves semi-structured interviews with participants in the intervention arm, interventionists and the PI. The RCT closed to recruitment on 31st May 2018, having successfully passed the original recruitment target of 556 participants, recruiting 608 participants in total. The trial is currently in follow up. Following the final 12-month research visit, some additional data collection will continue, with participant’s permission until, 30th June 2019. At this point, the study closes and the involvement of all participants ceases. After the trial ends (30/06/19), participants will have the option to enter into further CFHealthHub research should they wish.
This project is funded by the NIHR's Programme Grants for Applied Research.
Study Staff:
|
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 |