title: The OnTrack Diabetes Web-Based Program for Type 2 Diabetes and Dysphoria Self-Management: A Randomized Controlled Trial Protocol.
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.
  
  
  BACKGROUND
  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).
authors.affiliation: The Wesley Health and Medical Research Centre, Rural and remote health centre, Brisbane, Australia. mandy.cassimatis@usq.edu.au.
authors.forename: Mandy
authors.identifier: http://orcid.org/0000-0002-3678-4535
authors.initials: M
authors.lastname: Cassimatis
authors.forename: David John
authors.identifier: http://orcid.org/0000-0001-9072-8828
authors.initials: DJ
authors.lastname: Kavanagh
authors.forename: Andrew Paul
authors.identifier: http://orcid.org/0000-0002-6849-6116
authors.initials: AP
authors.lastname: Hills
authors.forename: Anthony Carl
authors.identifier: http://orcid.org/0000-0002-7756-5136
authors.initials: AC
authors.lastname: Smith
authors.forename: Paul A
authors.identifier: http://orcid.org/0000-0001-5931-642X
authors.initials: PA
authors.lastname: Scuffham
authors.forename: Christian
authors.identifier: http://orcid.org/0000-0002-7834-0406
authors.initials: C
authors.lastname: Gericke
authors.forename: Sophie
authors.identifier: http://orcid.org/0000-0002-9255-5278
authors.initials: S
authors.lastname: Parham
keywords: Internet; Web; anxiety; depression; diabetes mellitus, Type 2; intervention studies; online systems; randomized controlled trial; self care; therapy, computer-assisted