The Green Card Pilot: a randomised controlled trial of an education/reward intervention to aid diabetes self-management.

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Hypothesis Although it is widely accepted that lifestyle interventions In type 2 diabetes have a beneficial effect in delaying the negative health impact of the disease, achieving and maintaining long term gains remains problematic. Can gains in this area be made by combining an intervention program with a mechanism (the green card) for providing structured visual feedback, along with positive incentives, to induce people to persist with lifestyle change? Aims: The project aims to improve management of type 2 diabetics by: * providing a visual record through which a person with type 2 diabetes and their clinician can track their progress on core predictors of long term health * providing positive feedback into personal health trends * acting as a reminder that encourages adherence to diabetes control, including regular health checks * offering small retail incentives at participating stores which act as a positive re-enforcement to lifestyle changes. * Including educational material relevant to type 2 diabetics in a brochure mailed out to participants with their health summary. Research Plan The green card project is a mixed method cohort study intended to assist type 2 diabetics in their own management of the disease. It codifies three predictive areas of long term diabetic health: HbA1c, Blood Pressure (BP) and lipid profile, into a simple visual colour card. Each of the areas will be graded against a clinical value, with the highest values (furthest from the normal range) in the red zone at the top, moving down to the lowest (normal range) in the green zone at the bottom. Points will be accrued in each area in the following ways: * 100 points for attending a regular health check * 100 points for moving away from the red, and towards the green zone * 200 points for being in the green zone. Participants (minimum sample size 130) will be recruited via their GPs, Key area GPs who would be involved in the project have been consulted. They view this project to be appropriate for a clinical setting and have expressed willingness to participate. Qualitative data will be obtained through a participants’ survey at baseline and in 12 months. Questions incorporated the Health Belief Model and Social Cognitive Theory to assess participants’ individual understanding of their type 2 diabetes, the perceived importance of lifestyle changes, and the perceived ability to make and sustain lifestyle changes. One potential concern in a project such as The Green Card is that a failure to accrue points under the positive incentives provided may have a negative effect, discouraging the kinds of changes desired. People with co morbidities or lower educational backgrounds in particular may be at risk of failure to adhere and thus fail to gain rewards To prevent this, the card has been designed so that one area of points acquisition relies solely on the regular use of lipid lowering medication. This will ensure that participants who have enrolled in the project, but who are not able at a given point to commence active lifestyle changes, should still see an improvement in their points score profile. Likewise, HbA1C is a component of the card. Since HbA1C is extremely responsive to even small amounts of exercise, which may not have an effect on waist measurement within the three month assessment period, this measure will more easily show up as a positive change and a sensitive predictor of improvement in this area. Scientific basis of the study Large scale trials such as the Danish Steno-2 trial (Gaede, P et al 2003, and 2008) have established the benefits of lifestyle modification as an adjunct to pharmacological treatment of Type 2 Diabetes. In the Steno-2 trial, which has now been followed up for more than 13 years, health outcomes of participants vs. controls (receiving standard care) showed an absolute risk reduction of 20%, and a relative risk reduction of 50%. A meta-analysis into the long term effectiveness of lifestyle and behavioural intervention in adults with type 2 diabetes (Norris 2004) concluded: “weight loss and control in the long term appear to be difficult to achieve in adults with type 2 diabetes employing currently used lifestyle and behavioural strategies…Perhaps other strategies in conjunction with lifestyle interventions should be considered.” A search of the literature revealed no exactly comparable prototype for the present study. However, two central defining ideas correlate with findings in related studies. These are: 1.) The promising results of supported self-efficacy in diabetes management (Rieger 2009). Efficacy has been demonstrated across a wide spectrum of socio-economic and ethnic groups (Sarkar 2006). 2.) support mechanisms for maintaining lifestyle change in diabetes management should be open ended and ongoing.(Funnell 2007) Positive incentives have been shown to be of significant benefit in the treatment of a number of chronic conditions and habits. A recent RCT enrolling 878 US employees in a trial comparing positive financial incentives in smoking cessation vs. education only showed significantly higher rates of cessation in the incentives group compared to the education only group (Vollp NEJM 2009). A comprehensive review of Pay-for -Performance programs in the US (Vollp Health Affairs 2009) found that positive incentives were a cost effective strategy to improve a range of destructive behaviours including diet, smoking and asthma control. The most effective models used ‘frequent small rewards’, providing ‘tangible and visible’ incentives for good behaviour. Potential Significance The potential significance of this study is its potential to demonstrate that provision of positive incentives, through motivation and educational tools, accompanied by appropriate clinical support, can maximize the benefit of existing and future interventions to control type 2 diabetes. Given the large cost of diabetes to the community and the health care system, any initiative which enhances the effect of intervention strategies into this disease would represent a considerable health benefit. References: Gaede P, Vedel P, Larsen N. et al; Multifactorial Intervention and Cardiovacular Disease in Patients with Type 2 Diabetes. The New England Journal of Medicine 2003;348(5):383-393 Gaede P, Lund-Andersen H, Parving H, Pedersen O; Effect of a Multifactorial Intervention on Mortality in Type 2 Diabetes.. The New England Journal of Medicine 2008;358:580-591 Norris S, Zhang X, Avenell A, et al; Long-term effectiveness of lifestyle and behavioral weight loss interventions in adults with type 2 diabetes: a meta-analysis. American Journal of Medicine 2004;117(10):762-764 Rieger E; The use of motivational enhancement strategies for the maintenamce of weight loss among obese individuals: a preliminary investigation. Diabetes Obesity and Metabolism 2009;11:637-640 Funnell M, Tang T, Anderson R; From DSME to DSMS: Developing Empoerment-Based Diabetes Self-Management Support. Diabetes Spectrum 2007;20(4):221-226 Sarkar U, Fisher L, Schillinger D; Is self-efficacy associated with diabetes self-management across race/ethnicity and health literacy?.Diabetes Care 2006;29(4):823-829 Vollp K, Paully M, Glick H, et al; A Randomized, Controlled trial of financial Incentives in Smoking Cessation. The New England Journal of Medicine 2009;360(7):699 Vollp K, Pauly M, Loewenstein G, Bangsberg D; P4P4P: An Agenda for Research on Pay-For-Performance for Patients, Health Affairs 2009;28(1):206-215