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Trial registered on ANZCTR


Registration number
ACTRN12614001229662
Ethics application status
Approved
Date submitted
20/10/2014
Date registered
24/11/2014
Date last updated
2/12/2019
Date data sharing statement initially provided
2/12/2019
Date results information initially provided
2/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventing complications in people with type 2 diabetes by using new technologies to optimise self-management.
Scientific title
Improving self-management of type 2 diabetes using new technologies: The My Diabetes Coach Project.
Secondary ID [1] 285184 0
Nil
Universal Trial Number (UTN)
Trial acronym
My Diabetes Coach (MDC) Partnership Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 292784 0
Condition category
Condition code
Metabolic and Endocrine 293083 293083 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
-Links to general health information (National Heart Foundation, Healthinsite, Health Direct Information Line, Queensland Health, Department of Health Victoria, WA Health, Kidney Health Australia).

4.A Public Project Website
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.

5.A Program Coordinator
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 self-management data and alerts will be sent to his/her GP at regular intervals. At 6 – and 12-months, GPs will be contacted again and encouraged to review the participant’s progress according to his/her set targets and/or their preference for continuing use of the program and/or access to other DA self-management resources to facilitate program maintenance. Participants will be encouraged to discuss this with their GPs. The weekly chats will last approximately 20-30 minutes. The intervention period is 12-months during which time the GPs will receive summaries from their patient whenever the patient chooses to generate one (a feature of the program) and quarterly from the research team.
The current program is easily accessible by most Australians, requiring them to have an internet-enabled smart device but not requiring high English literacy or advanced technical skills. However, based on our evaluation to date and feedback provided by program consumers, program partners and our health advisory team, we have refined the program to include new modules (i.e., foot-care). Further, the mobile and Web “apps” to enhance user engagement and to improve links with GPs. Large scale implementation of technology-delivered programs to support T2DM self-management is very promising in Australia, as Australians are known to be high adopters of technology. For example, by mid-2013, >80% of mobile phone owners will own smartphones. Mobile networks now cover 99% of populated areas in Australia and >85% of Australian adults have at least reasonable access to a mobile phone service. Currently, 79% of all Australian households have internet access.
Intervention code [1] 290048 0
Lifestyle
Intervention code [2] 290049 0
Behaviour
Comparator / control treatment
Interested PWDs will be directed to contact the research project team who will randomly allocate them to either receive the program immediately (intervention group) for 12 months, or place them in the waitlist group.

The waitlist group will receive routine care from health care professionals and information about resources available via Diabetes Australia, and the National Diabetes Services Scheme (NDSS) or elsewhere. Both the intervention and waitlist groups will complete baseline, 6- and 12-month assessments to evaluate the effectiveness and maintenance of the program and compare diabetes-related complications between groups.
Control group
Active

Outcomes
Primary outcome [1] 292944 0
Program effectiveness (E) is 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; and body mass index (BMI), measured by weight (kg)/height (m2). The following outcomes will be measured by a self-report baseline questionnaire: health-rated quality of life, measured by the assessment of quality of life (AQoL)-8D; 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; 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.
Timepoint [1] 292944 0
Baseline (upon registration - prior to receiving access to the program) and 6- and 12-months Post-Baseline
Primary outcome [2] 293485 0
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.

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.
Timepoint [2] 293485 0
6 and 12 months post baseline
Secondary outcome [1] 309994 0
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.
Timepoint [1] 309994 0
6- & 12-months post-baseline

Eligibility
Key inclusion criteria
Project suitability requires NDSS registration of 10 years or less; age of at least 18 years;
basic English language skills, and access to a smart device (phone or tablet with iOS 8.0 or later, or Android 4.2XX or later).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Persons with Type 1 diabetes, persons diagnosed more than 10 years prior to registering in the NDSS, women who are currently or planning to become pregnant, and those with severe mental or physical illnesses will be excluded.
We will not exclude those who've recently started insulin treatment, but will delay their start until their insulin initiation phase concluded, i.e. a routine insulin dose has been established.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 289796 0
Government body
Name [1] 289796 0
National Health and Medical Research Council (NHMRC)
Address [1] 289796 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 289796 0
Australia
Funding source category [2] 289797 0
Charities/Societies/Foundations
Name [2] 289797 0
Diabetes Australia
Address [2] 289797 0
Diabetes Australia
GPO BOX 3156
CANBERRA ACT 2601
Country [2] 289797 0
Australia
Funding source category [3] 289798 0
Commercial sector/Industry
Name [3] 289798 0
Roche Diagnostics
Address [3] 289798 0
31 Victoria Avenue
Castle Hill NSW 2154
AUSTRALIA
Country [3] 289798 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
The University of Melbourne
Victoria 3010
Country
Australia
Secondary sponsor category [1] 288487 0
Charities/Societies/Foundations
Name [1] 288487 0
Diabetes Australia
Address [1] 288487 0
Diabetes Australia
GPO BOX 3156
CANBERRA ACT 2610
Country [1] 288487 0
Australia
Secondary sponsor category [2] 288488 0
Commercial sector/Industry
Name [2] 288488 0
Roche Diagnostics
Address [2] 288488 0
31 Victoria Avenue
Castle Hill NSW 2154
AUSTRALIA
Country [2] 288488 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291531 0
THE UNIVERSITY OF MELBOURNE HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 291531 0
Office for Research Ethics & Integrity
Level 1, 780 Elizabeth St
The University of Melbourne
VIC 3010
Ethics committee country [1] 291531 0
Australia
Date submitted for ethics approval [1] 291531 0
07/04/2014
Approval date [1] 291531 0
10/04/2014
Ethics approval number [1] 291531 0
1441847

Summary
Brief summary
This project aims to evaluate the 'real-world' implementation of a digital health program that is aimed to improve type 2 diabetes self-management. The trial will determine: i) the program’s reach, adoption, implementation and maintenance amongst persons with diabetes (PWDs) type 2; ii) clinical, psychosocial, and behavioural outcomes for PWDs provided with the program; and iii) the costs and value for money of the program.
Trial website
mydiabetescoach.mspgh.unimelb.edu.au/home
Trial related presentations / publications
Public notes
Full ethics approval was granted by the University of Melbourne's Faculty of Medicine, Dentistry and Health Sciences Human Ethics Sub-Committee (HESC) for the period May 28- December 31 2016..

Contacts
Principal investigator
Name 50758 0
Prof Brian Oldenburg
Address 50758 0
Chair of Noncommunicable Disease Control &
Director, Academic Centre for Health Equity
Melbourne School of Population and Global Health
Level 5, 207 Bouverie Street, The University of Melbourne
VIC 3010 AUSTRALIA
Country 50758 0
Australia
Phone 50758 0
+61-419025692
Fax 50758 0
Email 50758 0
brian.oldenburg@unimelb.edu.au
Contact person for public queries
Name 50759 0
Dr Professor Brian Oldenburg
Address 50759 0
Professor Brian Oldenburg
Melbourne School of Population and Global Health
Level 5, 207 Bouverie Street, The University of Melbourne
VIC 3010 AUSTRALIA
Country 50759 0
Australia
Phone 50759 0
+61 383440453
Fax 50759 0
+61-3-9654-7815
Email 50759 0
boldenburg@unimelb.edu.au
Contact person for scientific queries
Name 50760 0
Prof Brian Oldenburg
Address 50760 0
Chair of Noncommunicable Disease Control &
Director, Academic Centre for Health Equity
Melbourne School of Population and Global Health
Level 5, 207 Bouverie Street, The University of Melbourne
VIC 3010 AUSTRALIA
Country 50760 0
Australia
Phone 50760 0
+61-419025692
Fax 50760 0
Email 50760 0
brian.oldenburg@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The information-sharing needs to be decided by a specific case, please contact Prof. Oldenburg for any requiry.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary