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Trial registered on ANZCTR


Registration number
ACTRN12612000620820
Ethics application status
Approved
Date submitted
25/05/2012
Date registered
8/06/2012
Date last updated
19/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of an online support program for Type 2 diabetes self-management and dysphoria (depression, anxiety, and diabetes-specific distress).
Scientific title
Randomised controlled trial of OnTrack Diabetes: An online support program to improve Type 2 diabetes self-management and dysphoria
Secondary ID [1] 280552 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 286550 0
Dysphoria 286656 0
Condition category
Condition code
Public Health 286818 286818 0 0
Other public health
Metabolic and Endocrine 286949 286949 0 0
Diabetes
Mental Health 286950 286950 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
National randomised controlled trial of an automated, web-based program aimed to improve Type 2 diabetes self-management and dysphoria (depression, anxiety, and diabetes-specific distress) by primarily targeting physical activity, nutrition, health routines, and emotional well-being.
Being a self-guided program, participants use the program at their own discretion. The Intervention group are sent an email reminder if they have not logged on in >/= 2 weeks.
The prgoram has not set duration, as in, participants are free to access the program indefinitely, although the main trial period is 12 months (or, for participants who choose to be followed up in the future, 5 years).
There are three treatment arms in this trial, which involve the (i) usual care, (ii) wait-list control, and (iii) intervention arms. Usual care receives access to limited components of the full program throughout the trial (information resources, quizzes, and the health routines program module). The wait-list control arm receives access only to information resources and brief quizzes for the initial 3 months of participation, and then receives full program access. The intervention arm receives access to the full OnTrack Diabetes program. This includes information resources and brief quizzes on diabetes self-care (as accessible by treatment arms i and ii); self-monitoring tools and automated feedback graphs for physical activity and nutrition goal progress, blood glucose levels (daily highest and lowest), and mood (daily best and worst); access to My Diary, which is an electronic diary; and signposts for physical activity, eating, health routines, emotional wellbeing, and keeping ontrack, which each contain interactive tools based on cognitive behavioural therapy techniques of goal-setting, planning, problem-solving, etc, as well as mindfulness and meditation resources.
Intervention code [1] 284932 0
Behaviour
Intervention code [2] 284933 0
Lifestyle
Intervention code [3] 284934 0
Treatment: Other
Comparator / control treatment
Usual care: Limited access to online program content, including information resources and brief, self-administered diabetes self-care quizzes.
Control group
Active

Outcomes
Primary outcome [1] 287185 0
Glycaemic control (glyosylated haemoglobin level; HbA1c)
Timepoint [1] 287185 0
Baseline, 3, 6 and 12 months, and 5 years.
Primary outcome [2] 287186 0
Mood (depression, anxiety, diabetes-specific distress symptoms, asmeasured by the DASS-21, and two sub-scales of the Diabetes Distress Scale.
Timepoint [2] 287186 0
Baseline, 3, 6, and 12 months, and 5 years.
Secondary outcome [1] 297573 0
Diabetes self-care behaviours (physical activity participation, dietary intake, medication adherence...)
Physical activity participation is measured by the Active Australia Survey and Time Line Follow-back procedure (by phone interview); nutrition intake is assessed using the time line follow back procedure; and diabetes self-care is assessed by the Diabetes Self-care Activities Survey and the AusDiab Diabetes Self-Care Survey.
Timepoint [1] 297573 0
Baseline, 3, 6 and 12 months, and 5 years.
Secondary outcome [2] 297574 0
Self-efficacy for diabetes self-care, as measured by Kavanagh et al.'s Diabetes Self-Efficacy Scale.
Timepoint [2] 297574 0
Baseline, 3, 6, and 12 months and 5 years.
Secondary outcome [3] 297575 0
Quality of life, as measured by the SF-36 Quality of Life Questionnaire and the EQ-5D.
Timepoint [3] 297575 0
Baseline, 3, 6, and 12 months and 5 years
Secondary outcome [4] 297576 0
Qualitative outcomes - program acceptability, user satisfaction and acceptance, program usability, utility and implementation feasibility, as measured by the OnTrack Diabetes Evaluation survey - devised by Principal Investigator Kavanagh and CI Cassimatis, and by brief phone interview.
Timepoint [4] 297576 0
3 and 6 months
Secondary outcome [5] 297577 0
Program cost-effectiveness, as assessed using the Health Services Utilisation survey and self-reported medication intake.
Timepoint [5] 297577 0
End point result of baseline, 3-, 6-, 12-month and 5-year follow-up measures.

Eligibility
Key inclusion criteria
(a)Type 2 diabetes diagnosis >/= 3 months; (b)aged 18-75; reside in Australia; (c)HbA1c >/= 6.5%; (d)stable medication type >/= 3 months; (e)stable medication dose >/= 4 weeks; (f)access to computer with internet at least weekly.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a)Mental condition other than depression/anxiety; (b)Psychological treatment for diabetes management; (c)Oral steroid medication; (d)Pregnancy or lactation; (e)Physical limitations preventing physical activity; (f)suicidal ideation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1. Individuals register interest via program homepage and book a time for screening call.
2. Researcher phones individual at appointed time and undertakes eligibility screening interview.
3. If eligible, a time is arranged in the following week for time line follow back phone interview on eating and physical activity, and participant is sent study's baseline survey to complete before the next call.
4. Following TLFB interview, Researcher actions participant into the program. Program sends out username and confidential password to participant, and the program randomly allocates them to an experimental condition when they sign in.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is automated within the program. A 4 x 4 block randomisation schedule is used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The intervention arm receives the full intervention from baseline throughout the trial; the wait-list control condition receives access to generic diabetes self-care information and brief self-care quizzes for the first waive of the trial and then receives full program access; and the usual care condition receives access to a modified (brief) version of the program which includes the generic information resources, brief quizzes and one program module (health routines).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285317 0
Other Collaborative groups
Name [1] 285317 0
Wesley Research Institute
Country [1] 285317 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Institute of Health and Biomedical Innovation,
60 Musk Avenue,
Kelvin Grove,
Brisbane, QLD 4001
Country
Australia
Secondary sponsor category [1] 284174 0
Other Collaborative groups
Name [1] 284174 0
Wesley Research Institute
Address [1] 284174 0
The Wesley Health and Medical Research Insitute,
Level 8, East Wing, The Wesley Hospital,
451 Coronation Drive,
Auchenflower,
Brisbane,
QLD 4066
Country [1] 284174 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287334 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [1] 287334 0
Ethics committee country [1] 287334 0
Australia
Date submitted for ethics approval [1] 287334 0
10/05/2011
Approval date [1] 287334 0
06/06/2011
Ethics approval number [1] 287334 0
Cassimatis 9111
Ethics committee name [2] 287335 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [2] 287335 0
Ethics committee country [2] 287335 0
Australia
Date submitted for ethics approval [2] 287335 0
29/06/2011
Approval date [2] 287335 0
22/07/2011
Ethics approval number [2] 287335 0
1100000783

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34221 0
Address 34221 0
Country 34221 0
Phone 34221 0
Fax 34221 0
Email 34221 0
Contact person for public queries
Name 17468 0
Mandy Cassimatis
Address 17468 0
Wesley Research Institute,
Level 8, East Wing, The Wesley Hospital,
451 Coronation Drive,
Auchenflower
Brisbane QLD 4066
Country 17468 0
Australia
Phone 17468 0
+61 07 3721 1703
Fax 17468 0
+61 07 3721 1590
Email 17468 0
m1.cassimatis@qut.edu.au
Contact person for scientific queries
Name 8396 0
Professor David Kavanagh
Address 8396 0
Institute of Health and Biomedical Innovation,
Queensland University of Technology,
Kelvin Grove Campus
Level 4, 60 Musk Avenue,
Kelvin Grove,
Brisbane, QLD 4001
Country 8396 0
Australia
Phone 8396 0
+61 07 3138 6143
Fax 8396 0
+61 07 3138 6030
Email 8396 0
david.kavanagh@qut.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.