The Management to Optimise Diabetes and mEtabolic syndrome Risk reduction via Nurse-led intervention (MODERN) Study

A total of 300 individuals with clinically diagnosed metabolic syndrome (MetS) and/or type 2 diabetes mellitus (T2DM) will be randomised to Usual Care (UC, n=150) or the MODERN intervention (n=150). During the 24-month management program: 1. UC participants will visit the clinic and undergo non-invasive clinical assessments, finger prick blood samples to monitor their MetS risk factors and progression, complete research questionnaires about health behaviours’ and overall health status on 3 occasions (baseline, 12 and 24 months) that take approximately 60 minutes. 2. MODERN intervention participants will have between 1 and 4 extra clinic visits lasting approximately 60 minutes each over 24 months (in addition to the baseline, 12 and 24 months clinic visits). The exact number of visits will depend on the amount of assistance required to manage an individual’s level of risk based on the adaptation of the intensity of management according to risk and need using the GARDIAN (Green Amber Red Delineation of rIsk And Need) system. The GARDIAN system [*] is a traffic-light system developed to systematically categorise individual risk and need. Based on the initial comprehensive baseline profiling, each participant in the MODERN intervention group will be designated a traffic light colour RED (high), AMBER (intermediate) or GREEN (low), to describe the level of care provided by one of three management levels (+ additional visits): Green: 18 month contact; Amber: 6 and 18 month clinic visits; Red: 3, 6, 15 and 18 month clinic visits. These visits include non-invasive clinical assessments and finger prick blood samples to monitor their MetS risk factors and progression. The research nurse will provide an individual care plan according to identified risk factors (with input from nurse diabetes educators, the participant and their family/carers, and any other health care team members) and provide education and advice in order to minimise risk based on the 5As model. The 5As model consists of behavioural counselling to help individuals to change multiple health behaviours. The objective is to help participants to develop a personal action plan by systematically applying a series of five interrelated behaviour change principles. An outline of the sequence of support activities is as follows: Step 1 ASSESS i. biomedical, behavioural, socio-demographic and familial risk factor results in contrast to recommended levels from published guidelines and reports. ii. self-efficacy – beliefs (importance, confidence, intentions) in the participants ability to succeed in a particular situation (i.e. in their ability to complete tasks, change behaviours and reach goals). Step 2 ADVISE: i. health risks of the many risk factors linked to CVD and diabetes. ii. benefits of changing one or more behaviours. iii. recommend (based on published guidelines and reports) the appropriate amount, intensity and frequency of behaviour needed to help reduce the risk for CVD and diabetes. Step 3 AGREE: i. list and collaboratively set specific goals (in behavioural terms) based on the participant’s interest and confidence to perform the behaviour, which are mutually negotiated and achievable. ii. develop an agreed personal action plan (what, when, where, how). Step 4 ASSIST: i. list any real or anticipated personal barriers to achieving the identified goals and document strategies to overcome these barriers. ii. identify and aid in connecting with potential community programs or opportunities for lifestyle improvement and social support. iii. provide educational brochures to be used as a resource and reminder for behaviour change. Step 5 ARRANGE: i. specify a plan for follow-up visits, telephone calls, email reminders according to the GARDIAN system (see above). ii. recommend referral to a medical or allied health professional (e.g. dietician), including utilisation of video conferencing (Tele Health) for treatment or improved pharmacological management. iii. make use of self-monitoring and completion of a health passport to record behavioural and lifestyle changes for tracking progress and providing feedback. The clinic manager will be responsible for scheduling all clinic appointments based on a centralised database/calendar. All MODERN intervention participants will also be provided with a ‘MODERN Study Health Passport” with all scheduled appointments and all clinical results. This booklet also contains relevant health information and a comprehensive list of latest evidence-based guidelines and recommendations on metabolic syndrome and CVD risk factors. *Carrington MJ, Kok S, Jansen K, Stewart S. The Green, Amber, Red Delineation of Risk and Need (GARDIAN) management system: a pragmatic approach to optimizing heart health from primary prevention to chronic disease management. Eur J Cardiovasc Nurs 2013; 12(4):337-345.