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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).
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Scientific title
Randomised controlled trial of OnTrack Diabetes: An online support program to improve Type 2 diabetes self-management and dysphoria
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Secondary ID [1]
280552
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N/A
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Universal Trial Number (UTN)
N/A
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes
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Dysphoria
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Condition category
Condition code
Public Health
286818
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0
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Other public health
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Metabolic and Endocrine
286949
286949
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0
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Diabetes
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Mental Health
286950
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0
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Depression
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
284932
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Behaviour
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Intervention code [2]
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Lifestyle
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Intervention code [3]
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Treatment: Other
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Comparator / control treatment
Usual care: Limited access to online program content, including information resources and brief, self-administered diabetes self-care quizzes.
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Control group
Active
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Outcomes
Primary outcome [1]
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Glycaemic control (glyosylated haemoglobin level; HbA1c)
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Assessment method [1]
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Timepoint [1]
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Baseline, 3, 6 and 12 months, and 5 years.
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Primary outcome [2]
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Mood (depression, anxiety, diabetes-specific distress symptoms, asmeasured by the DASS-21, and two sub-scales of the Diabetes Distress Scale.
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Assessment method [2]
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Timepoint [2]
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Baseline, 3, 6, and 12 months, and 5 years.
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Secondary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Baseline, 3, 6 and 12 months, and 5 years.
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Secondary outcome [2]
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Self-efficacy for diabetes self-care, as measured by Kavanagh et al.'s Diabetes Self-Efficacy Scale.
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Assessment method [2]
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Timepoint [2]
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Baseline, 3, 6, and 12 months and 5 years.
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Secondary outcome [3]
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Quality of life, as measured by the SF-36 Quality of Life Questionnaire and the EQ-5D.
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Assessment method [3]
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Timepoint [3]
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Baseline, 3, 6, and 12 months and 5 years
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Secondary outcome [4]
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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.
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Assessment method [4]
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Timepoint [4]
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3 and 6 months
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Secondary outcome [5]
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Program cost-effectiveness, as assessed using the Health Services Utilisation survey and self-reported medication intake.
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Assessment method [5]
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Timepoint [5]
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End point result of baseline, 3-, 6-, 12-month and 5-year follow-up measures.
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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.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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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).
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/05/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Other Collaborative groups
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Name [1]
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Wesley Research Institute
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Address [1]
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The Wesley Health and Medical Research Institute
Level 8, East Wing, The Wesley Hospital,
451 Coronation Drive,
Auchenflower,
Brisbane QLD 4066
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Queensland University of Technology
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Address
Institute of Health and Biomedical Innovation,
60 Musk Avenue,
Kelvin Grove,
Brisbane, QLD 4001
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Country
Australia
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Secondary sponsor category [1]
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Other Collaborative groups
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Name [1]
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Wesley Research Institute
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Address [1]
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The Wesley Health and Medical Research Insitute,
Level 8, East Wing, The Wesley Hospital,
451 Coronation Drive,
Auchenflower,
Brisbane,
QLD 4066
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Country [1]
284174
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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UnitingCare Health Human Research Ethics Committee
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Ethics committee address [1]
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193 North Quay,
Brisbane QLD 4000
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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10/05/2011
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Approval date [1]
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06/06/2011
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Ethics approval number [1]
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Cassimatis 9111
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Ethics committee name [2]
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Queensland University of Technology University Human Research Ethics Committee
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Ethics committee address [2]
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Level 4, 88 Musk Avenue,
Queensland University of Technology
Kelvin Grove Campus,
Brisbane, QLD 4001
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Ethics committee country [2]
287335
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Australia
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Date submitted for ethics approval [2]
287335
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29/06/2011
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Approval date [2]
287335
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22/07/2011
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Ethics approval number [2]
287335
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1100000783
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Summary
Brief summary
This study evaluates the efficacy of a novel, online support program that targets Type 2 diabetes self-management and dysphoria symptoms in aiming to improve glycaemic control and emotional well-being. Secondary aims of the program are to improve behavioural outcomes (physical activity, dietary intake, and medication adherence), self-efficacy for diabetes self-care, and quality of life. Program evaluations include cost-effectiveness and qualitative outcomes, for example implementation feasibility, user satisfaction, program usability and acceptability.
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Trial website
www.ontrack.org.au/diabetes
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Trial related presentations / publications
Poster (International Society for Research on Internet Interventions Conference, 2011):
Cassimatis, M., Kavanagh, D., Hills, A., Scuffham, P., Smith, A., & Bauer, J. (2011). The OnTrack Diabetes Program: An Automated, Online Intervention for Type 2 Diabetes and Dysphoria Self-Management.
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Mandy Cassimatis
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Address
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Wesley Research Institute,
Level 8, East Wing, The Wesley Hospital,
451 Coronation Drive,
Auchenflower
Brisbane QLD 4066
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Country
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Australia
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Phone
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+61 07 3721 1703
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Fax
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+61 07 3721 1590
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Email
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[email protected]
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Contact person for scientific queries
Name
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Professor David Kavanagh
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Address
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Institute of Health and Biomedical Innovation,
Queensland University of Technology,
Kelvin Grove Campus
Level 4, 60 Musk Avenue,
Kelvin Grove,
Brisbane, QLD 4001
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Country
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Australia
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Phone
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+61 07 3138 6143
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Fax
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+61 07 3138 6030
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Email
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[email protected]
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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.
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