Title: Managing abnormal glucose in cystic fibrosis (MAGIC)- the development of a self-management education programme for people with cystic fibrosis related diabetes
Funder: Health Education England

Abstract: Background to the research Cystic fibrosis related diabetes (CFRD) affects 45-50% of adults with cystic fibrosis over 30 years. Its presence has a significant impact on nutritional status, respiratory function, morbidity and mortality. There are currently no self-management education programmes for patients with CFRD. It is unclear what the barriers and facilitators are to help patients manage the additional demands of CFRD, and specifically what interventions are needed to help improve self-management of CFRD. AimsThis study will develop an evidence-based self-management education programme for people with CFRD (MAGIC Managing Abnormal Glucose in Cystic Fibrosis) which will address the question: what are the educational/self-management requirements for people with CFRD and how can we best meet them? CHAR(13) + CHAR(10)Plan of investigation This study will be conducted in two stages. It is underpinned by the Medical Research Council's framework for the development of complex interventions. Stage 1a is a meta-ethnographical systematic review of qualitative literature; this will establish what is known about the experience of living with and managing CFRD from current literature. Stage 1b is a qualitative study guided by the principles of interpretative phenomenological analysis (IPA). IPA is an intricate method of qualitative analysis concerned with understanding and exploring the lived experience and how participants themselves make sense of their experiences. Up to ten participants with CFRD will take part in semi-structured interviews. These qualitative accounts from people with CFRD will provide insight into barriers and facilitators affecting self-management. It will establish what educational input people with CFRD would like and identify the skills and knowledge people with CFRD require. Stage 1a and b will take 20 months to complete. The results from stage one inform stage two. Stage two will be carried out by establishing a working group of ten lay representatives and ten healthcare professionals (HCP) to assist with developing the MAGIC programme. The Diabetes Manual will be the starting point for the programme; this is a structured type 2 diabetes patient-directed intervention, underpinned by self-efficacy theory for 1:1 delivery at home. Due to cross-infection risks patients with CF cannot mix together and therefore require 1:1 support. The working group will meet on four occasions, with contact between meetings maintained via email and telephone. The MAGIC programme will be developed as an e-learning platform, which is flexible for the lives of adults with CFRD, although this assumption (and others) will be tested in Sage 1b. Stage two will take 11 months to complete. Summary of potential benefits to patients and NHS The results of stage one of the proposed project will be disseminated at conferences and published in peer-reviewed open access journals thereby increasing the knowledge of HCP working with CF patients. The public and patients will also be informed of the results through Trust newsletters, web-pages and social networking. This study will produce an evidence-based programme designed by and for people with CFRD that will help improve self-care. It is anticipated this will have an impact on health by reducing morbidity, mortality and the risk of long-term diabetic complications. Patients won't have to attend hospitals to access this e-learning programme and this will reduce impact upon NHS time and resources. This study will generate a specific CFRD PPI community that can further inform the development of research in this area. Once the MAGIC programme has been developed it will be trialled out with a small number of patients within the hospital, this will help inform research protocols for a feasibility study and if appropriate, a randomised control trial for evaluating the effectiveness and impact of the MAGIC programme at a national level.

Lay abstract: Background to research Cystic fibrosis (CF) is a life-shortening genetic disease that damages many of the body's organs, including the lungs, pancreas and digestive system. Cystic fibrosis related diabetes (CFRD) is the most common complication of CF, affecting 45-50% of adults over 30 years. CFRD is different from type 1 and 2 diabetes and requires specialist dietary and clinical management. CFRD has a large impact on nutrition, lung function and survival. On average death is 3.5 times greater in people with CFRD. The need to educate people with CFRD is important because, keeping blood glucose controlled results in improvements in nutrition, and reduces the development of long term complications from CFRD, including death. The National Institute of Clinical Excellence recommends that everyone with diabetes should be offered a place on a diabetes self-management education programme. However, there are currently no diabetes self-management education programmes specifically for people with CFRD. Aim This study aims to develop an evidence-based self-management education programme for people with CFRD that will be called MAGIC (Managing Abnormal Glucose In Cystic fibrosis). Design and method This study will follow the Medical Research Council's framework for developing complex interventions this is considered the best way to develop a patient education programme. Stage one will find out all that is known about living with, and managing CFRD. A synthesis of the published qualitative literature will be carried out using an approach called a meta-ethnographical systematic review'. This is an effective approach that is widely used across social sciences. This part of the project will take 11 months Stage one will also include a qualitative study to collect data about living with and managing CFRD from up to ten patients. An interview schedule will be used to guide these discussions. Patients will be encouraged to tell their experiences in their own words. We are specifically interested in the ways in which people with CFRD make sense of their own experience of living with and managing CFRD and what help they need with self-management. This stage will use interpretative phenomenological analysis (IPA), which is a very detailed method of analysing qualitative data. The part of the project will take 9 months. Stage one will inform stage two. Stage two will develop the MAGIC programme. The patient interviews from stage one will provide insight into what helps with self-management. This will help establish what educational input people with CFRD want and identify the skills and knowledge required. A working group of ten patients, carers and patient/public involvement representatives, and ten healthcare professional will be set up to assist with developing the MAGIC programme. The starting point for the programme will be the Diabetes Manual, a widely used, type 2 diabetes patient learning package for 1:1 home use. Patients with CF cannot mix together due to cross-infection and therefore need 1:1 support. The working group will meet four times, with contact between meetings maintained via email and telephone. The MAGIC programme will be developed as an e-learning resource. It will be accessible via computers and mobile devices to limit hospital attendance, although this idea will be reviewed in stage one when we talk to the patients with CFRD. This part of the project will take 11 months. Once the MAGIC programme has been developed we will trial it with some patients within the hospital. This will help inform future studies required to evaluate how effective it is (feasibility study), and if appropriate a randomised control trial for evaluating the cost-effectiveness and the impact on well-being and survival of the MAGIC programme at a national level. Patient and public involvementPatients, carers and patient/public involvement representatives, will be involved in designing, planning and reporting of results of the MAGIC programme. Indeed the programme is an active partnership between healthcare professionals and the patients it aims to empower. This project will bring together a community of people focused on CFRD that can inform research in this area. There are many things we do not know about the best ways to care for, and treat CFRD. The group will tell us their priorities, and what needs to be developed to benefit CFRD patients. Dissemination The results from stage one will be disseminated at conferences and published in peer-reviewed open access journals. We will also inform the public and patients through Trust newsletters, web-pages and social networking. This study will produce an evidence-based programme (stage 2) designed by and for people with CFRD that will help improve their self-care.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: CONGENITAL DISORDERS;METABOLIC AND ENDOCRINE