The @RISK Study: Risk communication for patients with type 2 diabetes: design of a randomised controlled trial.
BACKGROUND
Patients with type 2 diabetes mellitus (T2DM) have an increased risk to develop severe diabetes related complications, especially cardiovascular disease (CVD). The risk to develop CVD can be estimated by means of risk formulas. However, patients have difficulties to understand the outcomes of these formulas. As a result, they may not recognize the importance of changing lifestyle and taking medication in time. Therefore, it is important to develop risk communication methods, that will improve the patients' understanding of risks associated with having diabetes, which enables them to make informed choices about their diabetes care.The aim of this study is to investigate the effects of an intervention focussed on the communication of the absolute 10-year risk to develop CVD on risk perception, attitude and intention to change lifestyle behaviour in patients with T2DM. The conceptual framework of the intervention is based on the Theory of Planned Behaviour and the Self-regulation Theory.


METHODS
A randomised controlled trial will be performed in the Diabetes Care System West-Friesland (DCS), a managed care system. Newly referred T2DM patients of the DCS, younger than 75 years will be eligible for the study. The intervention group will be exposed to risk communication on CVD, on top of standard managed care of the DCS. This intervention consists of a simple explanation on the causes and consequences of CVD, and possibilities for prevention. The probabilities of CVD in 10 year will be explained in natural frequencies and visualised by a population diagram. The control group will receive standard managed care. The primary outcome is appropriateness of risk perception. Secondary outcomes are attitude and intention to change lifestyle behaviour and illness perception. Differences between baseline and follow-up (2 and 12 weeks) between groups will be analysed according to the intention-to-treat principle. The study was powered on 120 patients in each group.


CONCLUSIONS
This innovative risk communication method based on two behavioural theories might improve patient's appropriateness of risk perception and attitude concerning lifestyle change. With a better understanding of their CVD risk, patients will be able to make informed choices concerning diabetes care.


BACKGROUND
The trial is registered as NTR1556 in the Dutch Trial Register.
Welschen
Laura M C
LM
Department of General Practice, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, the Netherlands. l.welschen@vumc.nl
Bot
Sandra D M
SD
Dekker
Jacqueline M
JM
Timmermans
Daniëlle R M
DR
van der Weijden
Trudy
T
Nijpels
Giel
G
D002318:Cardiovascular Diseases / Q000209:etiology; D003142:Communication; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D005260:Female; D006801:Humans; D008297:Male; D009426:Netherlands; D012107:Research Design; D018570:Risk Assessment; D040242:Risk Reduction Behavior; D011795:Surveys and Questionnaires