Research: Development of a research proposal to test the feasibility of an e-learning package for Cystic Fibrosis Related Diabetes
2016/73 - Paula Dyce
Cystic fibrosis (CF) is the United Kingdom’s (UK) most common genetic disorder affecting over 10,000 people (CF Trust, 2015). Patients are now living longer and developing further complications of the disease. Cystic fibrosis-related diabetes (CFRD) has become the most common co-morbidity of CF occurring in approximately 40-50% of patients (Moran et al 2009). CFRD differs from type 1 and type 2 diabetes and is often not differentiated by healthcare professionals. Due to this, there is currently no form of structured CFRD education for this specialised condition. A research proposal was devised, the aim of which is to test the feasibility of an specialist E-learning package. The importance of effective diagnosis and treatment for CFRD has been highlighted as the co-existence of CF and diabetes has been associated with worse lung function and poorer nutritional status when compared to non-diabetic patients with cystic fibrosis (Lanng et al 1992). Furthermore, evidence has shown stability and improvement in pulmonary function with good glucose control (Nousia et al 2001). CFRD has also been linked to an increase in early mortality of up to six fold (Rodman 1986) which again highlights the need for effective management of this growing complication of CF.
The study aims to help patients to improve their management of Cystic Fibrosis Related Diabetes by developing a structured educational package and an associated measure of CFRD knowledge.
The analysis of the proposed study will be multifaceted. Knowledge would be tested pre and post intervention (the e-learning package) by means of a specialist designed CFRD knowledge questionnaire. Clinical outcomes will be explored such as weight, glycosylated haemoglobin levels (HbA1c), lung function (predicted forced expiratory volume Fev1), and the amount of time with elevated glucose levels measured by a continuous glucose monitor for 5 days. Overall feasibility of the study will be tested and analysed using the following process described below;
Outcome measures for evaluation
- Exploration of how participants have found the process – survey monkey for e-learning group.
- Positive and Negative aspects of the e-learning programme – survey monkey questionnaire for e-learning group.
- Exploration of how participants found the programme - survey monkey questionnaire for e-learning group
- Ease of use/navigation
- Timing – length of programme
- Appropriateness of the programmes content
- Participation – Determining future sample size
- Willingness of participants
- Reasons why participants refuse recruitment
- What guides their behavioural choices
- Number of I pads/ resources available
- If the E-Learning is transferrable to other settings (i.e. community setting).
- How the programme would fit into existing clinical practice
- Length of time of the E learning programme takes to complete
- How many participants per clinic and are there time or resource restraints (room availability)
- Longitudinal – Part of annual screening system for CFRD
- Potential barriers to participation
- How well the intervention worked in different demographic groups
- Costs to organisation
- Has the programme covered conventional CFRD education
- Continuous glucose monitoring (primary method) statistical measurements of interstitial glucose over 5 days.
- Pulmonary function pre and post intervention- Association and correlation with diabetes/ infection and weight.
- HbA1c pre and post intervention – limitations of HbA1c in CF (justification why CGM is primary method of testing.
- Weight pre and post intervention – Weight in relation to CF and the difficulties of weight maintenance/ gain and association with diabetes and lung function.
- Patient diabetic knowledge questionnaire pre and post e-learning intervention – to ensure outcome measures are reliable and valid using an established psychometric test.
This study aims to test out how an e-learning intervention for CFRD would be received and if it has the potential to be efficacious in this specialised group of patients. Methodology choice was found to be of key importance when developing the research proposal with many of the supervisors for the study having conflicting views. Difficulties occurred when the original idea for research proposal didn’t appear to “fit” into the feasibility study model that the supervisory team were suggesting. The components in the study implied that the methodological approach was more likened to a pilot study. Education in CFRD using e-learning is a new intervention which has not previously been tested. Additionally, some of the tools which will be used to identify potential efficacy have no previous published data relating to the intervention. The supervisory team, therefore believed that a more appropriate to test the study and its components on its feasibility as there is no established trial protocol involving patient group or problems, intervention, comparison of intervention and outcome measurements (PICO). This further confused the analysis section of the study as some of the outcome measures were quantitative and very much fitted into a pilot study. A feasibility study has been chosen as the most appropriate method as this approach will explore all the components of the study and prepare for full scale research leading to intervention (Bowen et al 2009). The study will be developed to explore if the e-learning can, does and will work prior to piloting. Outcome measures have been included to explore efficacy potential adding to the reliability and validity of the trial protocol leading to a pilot study. This piece of work illustrates the importance of the correct methodological approach for future studies and the complexity and importance of a good supervisory team.
The first year of PhD study has been difficult and challenging. The experience has been fraught with difficulties both professionally and personally. I believe that it is important to remember that courses of study, timelines and life sometimes don’t always go to plan. Although the first year commenced without any issues, problems and difficulties occurred when three separate supervisors began to debate the best methodology required for the research project. I have found that PhD study is very fluid and the research proposal that you initially believed to be robust and adequate, may not necessarily be the ideal. The scholar need to be a robust and adaptable individual as you never know what life experiences one has to face whilst formulating research proposals and studying at this level.