Psychosocial Aspects of Artificial Pancreas Research
Research type
Research Study
Full title
Psychosocial Aspects of Artificial Pancreas (AP) Research Development and Validation of AP Specific Psychosocial Measure
IRAS ID
171863
Contact name
Katharine Barnard
Contact email
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Type 1 diabetes (T1D) remains the most common chronic disease of childhood and affects millions of adults and children globally. Artificial Pancreas (AP) research shows enormous promise and clinical trials are progressing rapidly. Psychosocial aspects of any AP devices (both single and dual hormone) are currently not well assessed in clinical trails meaning that we simply do not know enough about the hopes, anxieties, reasons for uptake, perceived benefits and barriers, impact on daily living and possible reasons for discontinuation of AP devices.
A reliable measure of the psychosocial impact of AP devices for users is crucial, both to make sure that regulatory authorities are able to consider these aspects as part of their approval process; but as importantly to ensure that the devices are 'fit for use' to maximize benefits both in terms of blood glucose control and quality of life to minimize the burden of diabetes in everyday life. Furthermore, the impact on significant relationships and the quality of life of parents and significant others is not captured, yet research shows that these factors are important to engagement and continuation with AP devices. Understanding these factors will ultimately lead to the most benefit for users. We plan to develop measures that will help research teams understand the factors important to users of AP devices. This includes living with the device and the impact on quality of life; so they can live their lives in the way that they want to.
Our highly expert, experienced, multi-disciplinary research team is well placed to conduct this robust, evidence-based, theory driven research. Investigators in the UK, at the Joslin Diabetes Center, the Lurie Children's Hospital, and Stanford University School of Medicine. Two lay experts at each centre will work with us and in collaboration with diabetes charities and other external experts.
We will conduct focus groups and interviews with participants and key stakeholders including family members, healthcare professionals and charity representatives to explore key issues, using this information to create self-administered measures. Separate measures will be developed for adults and children (children and adolescents separately), for family members and significant others. These measures will be tested with participants, in an iterative process. All five measures will be freely available once completed.
Scientific dissemination will occur via high impact peer-reviewed journals, academic and patient conferences . We will share of key results with stakeholders via PsychDT Working Group and publication of results; plus will have a set of dedicated communication activities including regular newsletters, updates, protocol publication and publication of results.
Measures will be freely available, with instructions for implementation and analyses for research teams to access and use. Support will be provided where required. Open-access web pages will be developed hosting the measures, background information, instruction for use, data analysis and reporting of results to promote consistency of reporting across clinical trials. These pages will enable easy access, collaborative working and provision of comparable psychosocial data across trials for regulatory approvals bodies.
REC name
West of Scotland REC 5
REC reference
15/WS/0020
Date of REC Opinion
22 Jan 2015
REC opinion
Favourable Opinion