Melbourne Diabetes Prevention Study (MDPS); A Randomised Control Trial of its Efficacy, Effectiveness and Cost Effectiveness
The dramatic increase in the prevalence of type 2 diabetes mellitus poses a major health problem worldwide. Diabetes is the second highest contributor to the Australian burden of disease and presents an enormous economic responsibility; hence the urgent need to implement a widespread and coordinated approach to its prevention. The diabetes prevention program developed by the Melbourne Diabetes Prevention Study team is a structured program involving individual and group education sessions related to diet, exercise and mental health. The program is a version of the ‘Life! helping you to prevent diabetes, heart disease and cardiovascular disease’ program that currently runs in Victoria, coordinated by Diabetes Australia-Victoria. The MDPS is studying high risk populations in southern and eastern metropolitan areas of Melbourne over a 12 month period using a randomised control study.
The MDPS aimed to:
- Evaluate the efficacy and effectiveness of the MDPS diabetes prevention program by monitoring clinical and behavioural outcomes before and after the intervention (particularly reduction in diabetes risk, weight and central obesity and changes in quality of life) and by comparing participants in the program with another cohort receiving usual care at the same time.
- Undertake an economic assessment of the MDPS diabetes prevention program by (a) evaluating whether it is ‘value-for-money’ through Cost Utility Analysis (CUA) and economic modelling of longer term impacts; and (b) evaluating technical efficiency issues through Cost-Effectiveness Analysis (CEA), combining resource usage data and clinical/behavioural outcomes.
- Assess a broad range of factors to supplement the technical analysis.
- Evaluate ‘usual care’ in the management of individuals at high risk of progression to type 2 diabetes.
Recruitment of participants for a pilot study began from a number of general practices in the Knox Division of General Practice in September 2009 with assistance from Greater Eastern Primary Health. The pilot study was completed in June 2011. Recruitment for the main study commenced in September 2011, with recruitment streams comprising community events, GP clinics, pharmacies and Life! provider organisations for people aged between 50 and 75 in Melbourne’s eastern suburbs who are at high risk of developing type 2 diabetes. Recruitment continued throughout 2012 with a large focus on pharmacy recruitment. During this time, over 2500 individuals were screened for Diabetes risk and over 340 consented for participation in the study. In 2012, Deakin University became a provider of the Life! program to more effectively deliver the intervention. In order to do so, an additional 3 staff members attended training to become accredited Life! facilitators. Recruitment concluded in February 2013, with the final baseline test being conducted in April 2013.
Mothers After Gestational Diabetes in Australia (MAGDA) study: Preventing Diabetes in Pregnancy from Progressing to Type 2 Diabetes: Macrolevel System Change in South Australia and Victoria
The Mothers After Gestational Diabetes in Australia (MAGDA) study is a National Health and Medical Research Council (NHMRC) Partnerships for Better Health project. Funded by NHMRC, SA Health, Victorian Department of Health and Human Services, and Diabetes Australia – Victoria, this is a unique project where stakeholders work together to build an improved policy for prevention of diabetes in this high risk group of women.
The primary project partners are:
NHMRC, Deakin University (Lead Agency), Flinders University, Melbourne University, Department of Health Victoria, SA Health, Diabetes Australia Victoria, Networking Health Victoria and Charles Darwin University.
Operating over a 5-year period (2011 – 2015), the project comprises of 4 studies:
Study 1: Gestational Diabetes Mellitus (GDM) screening, recall register and recall system.
Investigating the registration of pregnant women with GDM on the National Gestational Diabetes Register (NGDR) and the linkage of pathology laboratory data to measure the effectiveness of a reminder system to affect patient recall and testing. Study 1 partners include: Melbourne University’s GRHANITE™ Health Informatics Unit, Diabetes Australia National Gestational Diabetes Register, Melbourne Pathology, Healthscope, Dorevitch, SA Pathology and the Victorian and South Australian perinatal data collection units: Consultative Council on Obstetric and Paediatric Mortality and Morbidity (CCOPMM) and SA Pregnancy Outcome Unit.
Study 2: Randomised controlled trial of post-natal Diabetes Prevention Program for women with a history of GDM.
Currently in its final stages, the trial recruited 574 women with GDM, collected data post-natal at 3 time points over 12 months (blood samples, anthropometric measurements and comprehensive questionnaires) and educated participants by means of facilitated group lifestyle change programs. A program was developed specific to this population group (MAGDA DPP). Data collection ended at the end of May 2015 and results are expected to be published in late 2015.
Study 3: Economic assessments of screening, GDM registers and recall system, and MAGDA DPP.
Cost-Utility Analysis (CUA) and economic modelling of longer-term impacts to evaluate efficiency and ‘value for money’ as well as technical efficiency issues through Cost-Effectiveness Analysis (CEA), the combination of resource usage data and the recruitment/participation and clinical/behavioural outcomes.
Study 4: Moving from research and policy to operational health services.
From the outset the goal has been to influence both policy and practice through the sharing of evidence, learnings and experience across academia, government and health services providers.
Dr Sharleen O’Reilly leads the NHMRC TRIP Fellowship, GooD4Mum Collaborative Project, which aims to improve the diabetes prevention care provided to women with a history of gestational diabetes in participating Victorian general practices over a 12 month period. The MAGDA study outcomes are expected to be published in late 2015 / early 2016.
Depression Treatment Evaluation Care Team (D_TECT) (Chronic Disease Management of Co-morbid Depression, Heart Disease and Diabetes – Stage 1)
This project examined the clinical pathways for patients with co-morbid depression and diabetes using six general practices in the National Primary Care Collaboratives, which were required to set up chronic disease management systems with databases for recall. The project sought to determine where best to identify and intervene for patients with diabetes and depression.
Diabetes Prevention Project Initiative
This lifestyle intervention project which aimed to prevent the onset of type 2 diabetes among high risk individuals was undertaken in the Greater Green Triangle region between 2004 and 2006. Behavioural theories were combined with evidence-based intervention goals and strategies so that intervention could be undertaken in a primary health care setting.
Three General Practice Clinics in Hamilton and Horsham in Victoria and Mount Gambier in South Australia, participated in the study. A total of 311 adults were invited to participate in a series of structured group-counselling sessions facilitated by trained project nurses, dieticians and physiotherapists. The sessions aimed to motivate and support participants to adopt lifestyle changes – including modifying diet and physical activity levels – by providing them with the skills and social support needed for these changes to take place.
A new risk assessment tool for identification of patients at high risk of diabetes was introduced and used in this intervention. Results of this project provide evidence that a type 2 diabetes prevention program using lifestyle intervention is feasible in a primary health care setting, with reductions in risk factors approaching those observed in clinical trials.
Diabetes Prevention Project – Telephone Support Follow Up Study
The major aim of this project was to test the effectiveness of a simple support intervention to aid self-management – telephone follow up – in maintaining the health benefits for people who had participated in the Diabetes Prevention Project.
Participants were randomised to either a telephone support and self-care information (intervention group), or a self-care information only (control group).
Telephone support focussed on the project intervention goals and the participants’ own eating habits and physical activity goals and how well the patient was achieving or maintaining those goals. Participants were phoned a total of 12 times.
After 18 months, data were collected by a self-administered questionnaire and clinical and physical measurements taken from a total of 169 participants. The outcomes of primary interest were the biochemical and physical measurements – weight, waist circumference, blood pressure, total cholesterol, LDL, HDL, triglycerides, fasting glucose and oral glucose tolerance test – at 18 months after the original 12-month intervention, as well as adherence to self-care management guidelines, including diet and physical activity recommendations. A secondary analysis examined differences between intervention (self-care guidelines + telephone counselling)
Hospital Admission Reduction Program (HARP) (Evidence-Based Best Practice Model Clinical Pathways for People with Diabetes)
This project quantified hospital and other medical service utilisation for diabetes and diabetes complications and audited the associated diabetes management systems against recommended models. It also identified the psychosocial risk factors of depression and social isolation; systems barriers and enablers to optimum diabetes management and causes of preventable hospital admission for complications of diabetes.
PEACH: Patient Engagement and Coaching for Health: An Intensive Treatment Intervention for Patients with Type 2 Diabetes in Disadvantaged Communities
This study used a randomised controlled intervention to trial the use of practice nurses as ‘coaches’ to empower patients with type 2 diabetes to self-manage their condition and to more actively engage with their GPs in managing their condition.
Type 2 Diabetes and Depression: Assessing the Prevalence in Victoria and Identifying Effective Public Health Interventions
This project examined the extent of co-morbid depression (including depressive symptoms and disorders) among people with type 2 diabetes in ten General Practices throughout Victoria, and then made recommendations around the most effective public health interventions for the early detection and treatment of co-morbid depression among people with type 2 diabetes.