Lifestyle Intervention For Effective Diabetes Management (LIFE-DM) Trial

Diabetes is a leading cause of cardiovascular mortality and morbidity, and is more often than not a very difficult disease for individuals to manage effectively. People with diabetes have to be committed to a self-care regimen which includes, careful monitoring of blood sugar, blood pressure, cholesterol, eating healthy, exercising, foot care and regular physical and eye check-ups. This can be quite daunting and stressful for some to undertake themselves, and is largely dependent on individual self-motivation. Family physicians assist their patients in managing their diabetes but they have significant time constraints and may not always be able to deliver the high service intensity required to reduce morbidity and/or may have inadequate access to resources to help patients positively change their self-care behaviour.

Chronic disease-management programs involving home-based nursing health promotion have been shown to reduce mortality, reduce recurrent hospitalization, and improve indirect societal costs among specific subgroups of the population, including those with diabetes, however, such interventions can be costly and cumbersome to implement given the need for home-based visits.

INTERxVENT is a telephone-based, individualized, chronic cardiovascular and lifestyle management program combining a formal management plan, case-managed care (through a coach/mentor), and educational modules to teach patients to modify and sustain healthy lifestyle behaviours. It is comprised of several individualized modules (e.g., diet, exercise, stress management, smoking cessation, chronic disease), which are prescribed algorithmically in accordance to a patient's individual risk profile, environmental surroundings, and behavioural readiness to change. All recommendations are according to best-practice standards and evidence-based guidelines.

Nonrandomized intervention studies assessing INTERxVENT in diabetic, pre-diabetic, and metabolic syndrome populations have demonstrated significant reductions in biologically relevant measures, such as fasting glucose, glycosylated hemoglobin (HbA1c), lipids, and blood pressure. However, no randomized controlled clinical trials in these populations assessing the impact of INTERxVENT have been conducted.

The proposed pilot study will evaluate the efficacy of INTERxVENT as compared with 'usual medical care' in improving cardiovascular risk-factor profiles among individuals with diabetes. In addition, to what extent a chronic disease management program will yield similar effectiveness in socio-economically disadvantaged individuals is unknown. We hypothesize that chronic disease management programs, like INTERxVENT, will result in improved intermediary biological and behavioural risk profiles for all program participants randomized to this intervention, regardless of socio-economic condition.