Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001126606
Ethics application status
Approved
Date submitted
9/10/2014
Date registered
23/10/2014
Date last updated
23/10/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The OnTrack Diabetes Web-based Program for Type 2 Diabetes and Dysphoria Self-Management: A Randomised Controlled Trial
Scientific title
The effect of Functional Imagery Training (FIT) on health outcomes in patients with Type 2 diabetes who receive access to an online self-management program, OnTrack Diabetes.
Secondary ID [1] 285473 0
None
Universal Trial Number (UTN)
U1111-1162-7436
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 293250 0
Dysphoria 293294 0
Condition category
Condition code
Public Health 293520 293520 0 0
Health promotion/education
Mental Health 293521 293521 0 0
Other mental health disorders
Metabolic and Endocrine 293564 293564 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants receive access to an online self-guided diabetes management program, OnTrack Diabetes, and regular therapist support phone calls wherein FIT techniques are utilised. The therapist is a provisionally registered Psychologist who contacts participants twice in the first week of study enrolment, and once every fortnight until 3 months has elapsed. The first 2 calls last approx. 45mins, all remaining calls are 15mins. Participants are encouraged to practise FIT at home every day. The approach assists them to develop and maintain personalised changes to their diabetes self-care behaviours. The therapist reinforces the imagery-based activities already included in the OnTrack Diabetes program and extends these by encouraging additional imagery rehearsal to further enhance motivation.
FIT is grounded in the Elaborated Intrusion Theory of Desire which postulates that motivation is a process that involves elaboration of a mental representation of a target (often in the form of an image), to increase desire for that target. Therefore FIT attempts to increase the vividness and frequency of images of targets, where targets are functional behaviour (i.e. exercising). This is achieved by asking participants to elaborate on details of their goals and the benefits of those goals, while on the phone to the research therapist. The OnTrack Diabetes program offers modules on diet, physical activity, blood-sugar testing, adherence to medication and mood. These modules allow participants to consider if they want to make a change to these areas, and if so, how. Participants are encouraged to login to the modules a minimum of once a week. They may work at their own pace through the program. Tenants of Social Cognitive Theory, motivational interviewing, and CBT based problem-solving techniques are the foundation to the modules, such that participants are able to set and achieve their health goals. This is a 6-month trial, where participants are being tested for adherence via surveys at baseline, 3 and 6 months.
Intervention code [1] 290409 0
Behaviour
Intervention code [2] 290410 0
Lifestyle
Comparator / control treatment
There are 2 control groups. Participants who only receive access to OnTrack Diabetes, without FIT; and participants who continue with their usual care for 3-months, followed by access to OnTrack Diabetes
The participants who continue with usual care are asked to manage their diabetes as they always have (i.e. whether that is seeing health practitioners regularly, or making modifications on their own). Neither of these control groups will receive FIT after 3 months.
Control group
Active

Outcomes
Primary outcome [1] 293336 0
Adherence behaviours (assessed using questionnaires - Serves of fruit, vegetables, sweets, and fat per week (new survey designed for OnTrack Diabetes to assess diet), Active Australia Survey (physical activity), AusDiab Study Survey (medication + blood sugar testing)
Timepoint [1] 293336 0
Baseline, 3, 6 months
Primary outcome [2] 293378 0
Mental health (assessed by questionnaires - Depression, Anxiety, Stress Scale; Diabetes Distress Scale)
Timepoint [2] 293378 0
Baseline, 3 and 6 months
Secondary outcome [1] 310818 0
HbA1c (assessed by blood sample from their GP)
Timepoint [1] 310818 0
Baseline, 3, and 6 months
Secondary outcome [2] 310889 0
Quality of Life (EQ-5D)
Timepoint [2] 310889 0
baseline, 3, 6 months
Secondary outcome [3] 310890 0
Self Efficacy (Diabetes Self-Efficacy Scale)
Timepoint [3] 310890 0
Baseline, 3, 6 months

Eligibility
Key inclusion criteria
(a) Type 2 diabetes diagnosis (by a medical doctor and/ according to WHO criteria) for 3 or more months; (b) aged 18 years or older; (c) living in Australia without plans to leave within 12 months; (d) regular computer and internet access ; (e) contactable by phone; (f) clear command of written English (at least year 5 education); and (g) stable diabetes pharmacotherapy (medication dose stable for past 4 weeks; medication type stable past 3 months).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) current diagnosis of mental disorder other than depression or anxiety (participant is asked if a condition has been diagnosed and if so they are informed that they will receive access to the program but not be included in the trial); (b) current suicidal risk (assessed via suicide risk assessment); (c) significant cognitive disorder (e.g. from head trauma or dementia); (d) currently on steroid medication , or likely to commence these in the next 12 months; (e) pregnant or likely to become pregnant in the next 12 months.

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)
Recruitment and screening. Ineligible participants offered access to program. Eligible participants asked to obtain current HbA1c or provide most recent HbA1c (must be within last 4 weeks). Participants then complete a baseline survey related to their clinical status, demographics, lifestyle and experience of diabetes. Once completed participants are randomly allocated to one of the 3 groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The online program OnTrack Diabetes randomly allocates participants to one of the 3 groups when we activate them after they complete the baseline survey.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The OnTrack Diabetes program (www.ontrack.org.au/diabetes) stores participants details. A researcher approves the participant once they have completed the baseline survey and the program then randomly allocates the participant to one of the 3 research groups (delayed, immediate, or immediate + FIT)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Preliminary analyses assess for baseline differences, and subsequent analyses control for any observed differences. The primary analyses will comprise multiple regressions, predicting post-treatment and follow-up results from Baseline measures and treatment contrasts, with multiple imputation being used to predict missing data. Mixed models ANOVAs with repeated measures will also be applied, to confirm whether effects are still obtained without imputations. Both methods allow an intention-to-treat (ITT) approach to the data. Repeated Measures ANOVAs will be used to evaluate differences in change scores between the study time points between the three study conditions.
User satisfaction, perceived ease of use, and usefulness are examined with ANOVAs, and
program reach, acceptability, implementation feasibility and outreach are assessed using the RE-AIM framework. This will be operationalised using the OnTrack Diabetes Evaluation Questionnaire, which asks about users’ perceptions of the progam’s acceptability, issues with feasibility and outreach (i.e. ability to access the program, barriers to access including poor broadband network availability). The inclusion of residents of rural and regional areas enriches this evaluation, as will quantitative data about participants’ exposure to the program.
A total of 210 participants will be recruited to observe a small effect size (f2 = .046).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 3041 0
The Wesley Hospital - Auchenflower

Funding & Sponsors
Funding source category [1] 290075 0
Other Collaborative groups
Name [1] 290075 0
The Wesley St Andrews Research Institute
Country [1] 290075 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
QUT
Victoria Park Rd, Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 288770 0
None
Name [1] 288770 0
Address [1] 288770 0
Country [1] 288770 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291782 0
Uniting Care Health, Queensland
Ethics committee address [1] 291782 0
Level 5
193 North Quay
Brisbane QLD
4000
Ethics committee country [1] 291782 0
Australia
Date submitted for ethics approval [1] 291782 0
Approval date [1] 291782 0
14/06/2011
Ethics approval number [1] 291782 0
Cassimatis9111

Summary
Brief summary
The RCT compares three treatments: (i) Delayed Program Access – undertakes usual diabetes care for 3 months Post-Baseline, followed by access to the full OnTrack Diabetes program, (ii) Immediate Program – receives full access to the self-guided program from Baseline onwards, and (iii) Immediate Program plus Therapist Support. Measures are administered at Baseline, and at 3, 6, and 12 months Post-Baseline. Outcomes are glycosylated haemoglobin A1c (HbA1c) level and diabetes-specific distress, depression, anxiety, diabetes self-care, self-efficacy and adherence, and quality of life. Exposure data in terms of program uptake, use, time on each page, and program completion as well as implementation feasibility, will be conducted.
It is predicted that OnTrack Diabetes will improve adherenec to diabetes self-care behaviours and FIT will enhance this effect. This is the first known trial of an automated, self-guided, web-based support program that uses a holistic approach in targeting both Type 2 diabetes self-management and dysphoria. Findings will inform the feasibility of implementing such a program on an ongoing basis, including in rural and regional locations.
Trial website
www.ontrack.org.au/diabetes
Trial related presentations / publications
Cassimatis, M., Kavanagh, D.J., Hills, A.P., Smith, A.C., & Scuffham, P.A. (2013). Study Protocol of The OnTrack Diabetes Project: Randomised Trial of An Automated, Interactive, Web-based Type 2 Diabetes Self-management and Dysphoria Intervention. Journal of Medical Internet Research.

Cassimatis, M., Kavanagh, D.J., Hills, A.P., Smith, A.C., & Scuffham, P.A. (2013). Development of the OnTrack Diabetes Program and Design of a Randomized Controlled Evaluation Trial. Journal of Medical Internet Research.
Public notes

Contacts
Principal investigator
Name 52006 0
Ms Sophie Parham
Address 52006 0
PO Box 499 Toowong QLD 4066

or

Level 8, East Wing, The Wesley Hospital
451 Coronation Drive Auchenflower QLD 4066
Country 52006 0
Australia
Phone 52006 0
+61 07 3721 1721
Fax 52006 0
Email 52006 0
sparham@wesleyresearch.com.au
Contact person for public queries
Name 52007 0
Ms Sophie Parham
Address 52007 0
PO Box 499 Toowong QLD 4066

or

Level 8, East Wing, The Wesley Hospital
451 Coronation Drive Auchenflower QLD 4066
Country 52007 0
Australia
Phone 52007 0
+61 07 3721 1721
Fax 52007 0
Email 52007 0
sparham@wesleyresearch.com.au
Contact person for scientific queries
Name 52008 0
Ms Sophie Parham
Address 52008 0
PO Box 499 Toowong QLD 4066

or

Level 8, East Wing, The Wesley Hospital
451 Coronation Drive Auchenflower QLD 4066
Country 52008 0
Australia
Phone 52008 0
+61 07 3721 1721
Fax 52008 0
Email 52008 0
sparham@wesleyresearch.com.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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