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. 2015 Aug 4;4(3):e97.
doi: 10.2196/resprot.2813.

The OnTrack Diabetes Web-Based Program for Type 2 Diabetes and Dysphoria Self-Management: A Randomized Controlled Trial Protocol

Mandy Cassimatis  1 , David John Kavanagh, Andrew Paul Hills, Anthony Carl Smith, Paul A Scuffham, Christian Gericke, Sophie Parham
Affiliations

The OnTrack Diabetes Web-Based Program for Type 2 Diabetes and Dysphoria Self-Management: A Randomized Controlled Trial Protocol

Mandy Cassimatis et al. JMIR Res Protoc. .

Abstract

Background: The prevalence of type 2 diabetes is rising with the majority of patients practicing inadequate disease self-management. Depression, anxiety, and diabetes-specific distress present motivational challenges to adequate self-care. Health systems globally struggle to deliver routine services that are accessible to the entire population, in particular in rural areas. Web-based diabetes self-management interventions can provide frequent, accessible support regardless of time and location

Objective: This paper describes the protocol of an Australian national randomized controlled trial (RCT) of the OnTrack Diabetes program, an automated, interactive, self-guided Web program aimed to improve glycemic control, diabetes self-care, and dysphoria symptoms in type 2 diabetes patients.

Methods: A small pilot trial is conducted that primarily tests program functionality, efficacy, and user acceptability and satisfaction. This is followed by the main RCT, which compares 3 treatments: (1) delayed program access: usual diabetes care for 3 months postbaseline followed by access to the full OnTrack Diabetes program; (2) immediate program: full access to the self-guided program from baseline onward; and (3) immediate program plus therapist support via Functional Imagery Training (FIT). Measures are administered at baseline and at 3, 6, and 12 months postbaseline. Primary outcomes are diabetes self-care behaviors (physical activity participation, diet, medication adherence, and blood glucose monitoring), glycated hemoglobin A1c (HbA1c) level, and diabetes-specific distress. Secondary outcomes are depression, anxiety, 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.

Results: This trial is currently underway with funding support from the Wesley Research Institute in Brisbane, Australia.

Conclusions: 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 registration: Australian and New Zealand Clinical Trials Registration number: ACTRN12612000620820; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000620820 (Archived by WebCite at http://www.webcitation.org/6a3BeXC5m).

Keywords: Internet; Web; anxiety; depression; diabetes mellitus, Type 2; intervention studies; online systems; randomized controlled trial; self care; therapy, computer-assisted.

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Conflict of interest statement

Conflicts of Interest: MC and DK wrote the Web-based program evaluated in this study, but they do not obtain commercial gain from its use. All other authors have no competing interests to declare.

Figures

Figure 1
Figure 1
Screenshot of the OnTrack Diabetes home page.
Figure 2
Figure 2
CONSORT flow diagram of the OnTrack Diabetes main randomized controlled trial.
See this image and copyright information in PMC

References

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