Norwegian primary prevention randomised control trial of CVD: what is best?

Control of cardiovascular risk factors is not optimal in Europe. In this interesting and well-designed Norwegian randomised control trial (RCT) that was recently published in the European Journal of Preventive Cardiology, the authors investigated the efficacy of a multimodal primary prevention programme based on the existing health care system (1). 

Almost 600 patients with elevated cardiovascular risk were randomised to a hospital-based lifestyle course for five days and primary care follow up or to a control group. The patients were included between 2011 and 2015 from general practitioners and followed for 36 months by the general practitioner including digital follow-up. Primary endpoint was the change in validated risk scores, including the Norwegian NORRISK 2 (2). Secondary endpoints included major risk factors. 

The intervention was performed in a multidisciplinary setting with a physician, dietician, physiotherapist, and nurse in groups of 6-15 participants. Mean age was 54 years and 36% were female. The intervention followed national guidelines for lifestyle and medication and was focused on diet, physical activity, smoking cessation, stress management, motivation, and individual goal setting. Exercise capacity and baseline risk was communicated to the patients. The goal setting included encouragement to establish individual, ambitious, realistic lifestyle change goals and a plan for the follow up period. 

The digital follow-up included a communication tool, where the patients were asked to report about their goal achievement and challenges, and they got short, personalised motivational feedback from study staff. The participants could also communicate with each other and send questions to the staff, that would be answered. Newsletters were sent four times a year, and a website was available for information. The follow-up in primary care was left to the physician to decide based on clinical judgement and the information regarding risk factors, goals, and individual plan.

The NORRISK 2 score as well as the other risk scores were significantly improved in the intervention group compared to the control group. This was based on significant reduction in smoking habits and improvement of metabolic syndrome elements. Blood pressure and cholesterol were not significantly reduced. The results are similar to other studies reporting effects on risk scores. The question is, however, whether similar results could be achieved without the initial five days programme at the hospital and all intervention performed in primary care. What is actually best? Maybe an introduction course could be given at the community level at Healthy Life Centres. This would be cheaper for the society and available for all, but it should be tested in an RCT whether the effect is comparable to what was achieved in this study.