Preventing complications in people with type 2 diabetes by using new technologies to optimise self-management.

INTERVENTION: Participants randomised to the intervention group will receive access to the My Diabetes Coach program which consists of four complementary components: 1. A smart phone and/or web based application The app uses the latest digital technology to deliver support and resources to people with type 2 diabetes. Over a series of sessions, a virtual 'coach' interacts with and provides feedback on blood glucose monitoring, healthy eating, physical activity, foot‐care and medication taking. The behaviour change strategies used within the application will complement strategies used within the other components of the program, providing a seamless experience for the participant. For example, the goal setting strategies within the application will be complemented by a section within the user guide providing an explanation of the benefits of setting goals. Finally the application will have built in reminders at the end of each chat to remind users to also use the user guide and participant website to get the most of the program. Participants will be encouraged to use the app weekly, after uploading their previous week’s BG readings. They will also receive a blood glucose (BG) uploading kit: a new Roche Diagnostics Bluetooth‐equipped BG meter with capability to upload self‐monitored BG readings to the program database via smartphone "app". We estimate that 25% of participants will either not own a smartphone and/or will prefer to continue to use their own meter. Those who choose this option will be able to manually update their BG via the app. Roche Diagnostics will provide BG meters and uploading devices (SmartPix) at no cost for this study, which participants may or may not use i.e. they can use their own existing monitor. 2.A User Guide The user guide complements the use of the app and contains information to help users to get the most out of My Diabetes Coach program. Included within the guide is an introductory module on how to use the program for the first time, a frequently asked questions section, an explanation of the usefulness of using goal setting and problem solving strategies, tracking sheets for participants to record your progress throughout the program, and sources of more information on managing diabetes. 3. A Private Participant Website The program website will be restricted to the users of the program and will contain specific content that will complement the smart device application and user guide. The planned components of the website include: ‐Electronic version of the GP information sheet that participants can download and show to their health care professionals ‐Electronic versions of all sections of the user guide ‐Electronic versions of Diabetes Australia Factsheets (blood glucose monitoring, hypoglycaemia and diabetes, physical activity and type 2 diabetes, food choices for people with diabetes, medications for type 2 diabetes, sick days and type 2 diabetes, diabetes and your feet, smoking, prediabetes and diabetes, depression and diabetes) and links to state specific information Diabetes Queensland, Diabetes WA and Diabetes Victoria. ‐An online community that participants can read and comment upon ‐Links to helpful information about eye health and diabetes (Vision Australia and Macular Disease Foundation Australia) 4.A Public Project Website 5.A Program Coordinator CONDITION: Type 2 Diabetes ; ‐Links to general health information (National Heart Foundation, Healthinsite, Health Direct Information Line, Queensland Health, Department of Health Victoria, WA Health, Kidney Health Australia). This project website will have general information about the project and the people involved with its execution, as well as an expression of interest form and general information for GP’s and health professionals. The Coordinator trains participants in how to use the app, resolves any technical issues relating to use of the app, and responds to and relays clinical alerts produced by the system to GP’s when necessary. After receiving the participants registration, and consent form, and prior to receiving access to the app, the research team will send a letter to their GP which will explain how the GP can help participants to tailor the program to the person with diabetes’ (PWD) needs i.e. asking them to provide individualised self‐care clinical targets (e.g. targets for BG, and frequency of testing, and physical activity goals). The latter will be entered into the program database to tailor conversations with each person. These steps have been implemented successfully with more than 95% of previous trial participants. Participants will be contacted at weeks 4, 8, 12 and 24 weeks to elicit and address any difficulties. Additionally, alerts will be generated by the system, prompting the Research Team to call the participant if s/he does not call the program for two consecutive weeks and/or after any clinical alerts (e.g. high/low BG levels) or technical alerts (e.g. BG uploading failed). A summary of the participant’s ; Specifically, it will be measured by the following questions: How do we ensure: Implementation in various contexts and groups? Adherence to program delivery? There are no barriers and enablers to delivery? The cost of delivery and staffing requirements are kept low? The answers will be provided by logs of study invitation letters sent and queries received by DA staff, Diabetes Australia staff, coordinator and users’ interviews, GP questionnaires and interviews, program/system logs, coordinator notes, user acceptability questionnaires, and implementation cost questionnaires. INCLUSION CRITERIA: Project suitability requires NDSS registration of less than 10 years in duration; age of at least 18 years; basic English language skills, and a smart device (phone or tablet with iOS 8.1 or later, or Android 4.2XX or later). PRIMARY OUTCOME: Program Effectiveness measured via three methods: i) self‐completed questionnaires; ii) pathology as part of diabetes annual cycle of care; and iii) other clinical measurements by GP as part of annual cycle of care. The following clinical outcomes will be measured by a GP: Blood Glucose, measured by HbA1c; Fasting Lipid profile, measured by (total cholesterol, LDL, HDL, triglycerides, blood sample (HCP); blood pressure, measured by BP systolic/diastolic; Body Mass Index (BMI), measured by Weight (kg)/Height (m2); waist circumference, measured in cm. The following outcomes will be measured by a self‐report baseline questionnaire: Self‐rated health physical and mental health, degree to which activity is limited by health, and quality of life, measured by the SF‐36; Medication adherence, number of days per week medication is taken as prescribed, measured by the Summary of Diabetes Self Care Activities (SDSCA) instrument; nutrition, number of serves of fruit & vegetables/day, measured by the National Nutrition Survey; Confidence in self‐management of type 2 diabetes and how PWDs could overcome barriers, measured by the Confidence in Diabetes Scale (CIDS‐II); Physical activity, number of physical activity minutes/week, number of physical activity sessions/week; foot care, frequency of foot checks, measured by the expanded SDSCA; health‐related quality of life, health status, measured by the SF‐36; emotional wellbeing, anxiety and depression symptoms (measured by the Hospital Anxiety and Depression Scale – HADS) and diabetes related distress (measured by the Problem Areas in Diabetes instrument – PAID); smoking status, current, ex‐smoker, never smoked, measured by self‐reported frequency and status. We will also measure self‐reported absenteeism, presenteeism (working when ill), and absenteeism‐ and presenteeism‐related lost productive time. Program Reach, Adoption, Implementation and Maintenance will be collected at the end of the program delivery phase in Victoria, Queensland, and Western Australia for each of the relevant RE‐AIM dimensions, with a particular focus on vulnerable and disadvantaged populations. We shall also assess both Waitlist and Intervention group participants' use of other ICT resources related to self‐management during the study and follow‐up. SECONDARY OUTCOME: Economic evaluation ‐ Costing data will include staff costs and equipment costs for operating the program. Data on healthcare utilisation and implementation of the program will also be collected. Primary care and other community service use as well as hospitalisations will be collected using standard costing questionnaires. Quality adjusted life year (QALY) data will be calculated using the AQoL‐8D administered at baseline and 12‐month, for which Australian‐specific conversion algorithms are available. For the implementation analysis, data on the staffing needs, staff and participant training, and infrastructure costs will also be collected during the trial. In addition, throughput and “staff load” will be recorded. A standardised questionnaire will be developed and administered online with key informants for this purpose.