Purpose: To describe the development of a five year research programme and discuss key lessons learned over the first half of the programme.
Method: A multi-disciplinary team incorporating physicians, diabetic nurses and educators, psychologists, clinical trialists, statisticians, and health economic modellers combined to develop an integrated five year research programme investigating the education programme Dose Adjustment For Normal Eating (DAFNE). A previous randomised controlled trial (RCT) of DAFNE showed some benefits overall but a heterogeneous response amongst patients undertaking the five day course, leading to a series of policy questions concerning who should receive the educational intervention, whether the intervention should be redesigned in some way, and how those who do not respond as successfully can be best supported in their ongoing self management.
Result: The UK National Institute for Health Research has funded the programme which consists of the following key elements:
- A multi-centre observational study of approximately n=1,100 recruiting over 2 to 3 years from education programs nationally to measure clinical data, resource use, disease specific (DSQoL) and generic (SF12 and EQ5D) quality of life measures at baseline and 12-month follow-up.
- A quantitative psychosocial study of n=262 course participants, measuring psychological (self-efficacy, self-care etc.), behavioural, clinical and demographic data at baseline and 3-, 6- and 12-month follow-up.
- A qualitative psychosocial study involving in-depth interviews and direct observation of courses to focus on barriers and facilitators of successful adoption of DAFNE behaviours and principles.
- Design and implementation of a RCT comparing the five day course with a newly designed course offering one session per week over five weeks.
- Design of a potential additional trial comparing education alone verses education plus insulin pumps.
- Development of quantitative behavioural models based on the psychosocial study and integration of these within an patient level simulation model of long-term type 1 diabetes complications, mortality, morbidity, costs and quality-adjusted life-years.
- Planned analyses include exploring predictive power of covariates for successful adoption of behaviours, subgroup analyses, and cost-effectiveness of alternative strategies for long-term self management.
Conclusion: The integrated package of psychological, clinical trial and health economic outcomes research has been funded by the NIHR and is now in its third year. We discuss lessons on the design and implementation of the integrated framework.
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