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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
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.
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.
This trial is currently underway with funding support from the Wesley Research Institute in Brisbane, Australia.
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.
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).
Diabetes mellitus affects an estimated 346 million people globally and type 2 diabetes accounts for 85% to 90% of all cases [
Depression [
Prior research indicates the need for behavioral diabetes self-management interventions to incorporate psychological and emotional support components for optimum efficacy [
There are many barriers to adequate treatment of type 2 diabetes within health systems, including a shortage of health professionals, inadequate availability of services, limited access in rural and remote regions, practitioner/patient communication problems, time pressures in medical consultations, and limitations in the skills and confidence of health professionals in the provision of psychological interventions [
Recent evidence demonstrates that Web-based diabetes self-management interventions have potential efficacy, feasibility, user acceptability, and uptake [
Recently trialed Web-based diabetes self-management programs based on social cognitive theory (SCT) [
Despite the growth in supportive evidence on Web-based diabetes programs for self-management, there are some inconsistencies in their results and further data are needed on their potential to improve glycemic control [
Developing and maintaining commitment to any significant behavior change is challenging. Over the last 30 years, motivational interviewing [
The study described subsequently comprises a randomized controlled trial (RCT) involving the OnTrack Diabetes program, an automated Web-based intervention aimed to achieve and maintain improvements in type 2 diabetes self-management and dysphoria symptoms. It compares delayed and immediate access to the program, and immediate access supplemented by FIT-based coaching.
The development of OnTrack Diabetes is described in a companion paper [
Screenshot of the OnTrack Diabetes home page.
A pilot trial of the program is initially implemented to test for program functionality and to provide an indication of program efficacy, user acceptability, and satisfaction. Following the pilot, a RCT with the participant as the unit of randomization is implemented. The trial is conducted Australia-wide and access is ongoing. The research team is based at the Mitsubishi Centre for Rural and Remote Health at the Wesley Research Institute in Brisbane.
The RCT evaluates the efficacy of the OnTrack Diabetes program in improving the primary outcomes glycemic control (HbA1c level) and diabetes-specific distress symptoms, and the secondary outcomes of depression, anxiety, physical activity participation, diet, blood glucose self-monitoring, and medication taking. User acceptability, ease of use, utility, program satisfaction, and implementation feasibility are also assessed.
It is hypothesized that at 3 months postbaseline, the immediate access plus FIT condition will show the greatest improvements in primary and secondary outcomes compared with the immediate access and the delayed access conditions. Results of the immediate access and the delayed access conditions are expected to be similar at 6 months when both conditions will have received the full intervention. A CONSORT flow diagram for the trial is shown in
CONSORT flow diagram of the OnTrack Diabetes main randomized controlled trial.
Recruitment strategies for the trial are primarily community-based: newspaper advertisements, health organization newsletters, radio broadcasts, notice board postings, bulletins, emails, and online advertisements. Targeted methods include the distribution of study flyers and posters to medical centers, letters to health institutions, pharmacies and health professionals, and featuring the OnTrack Diabetes website URL on statewide Diabetes Australia research Web pages. Attendance at diabetes-related expos and events allows in-person recruitment and further promotion of the project to health professionals.
The trial aims to enroll at least 210 participants. Selection criteria include (1) type 2 diabetes diagnosis (by a medical doctor and according to World Health Organization criteria) of at least 3 months duration, (2) age 18 years or older, (3) living in Australia without plans to leave within 12 months, (4) regular computer and Internet access, (5) contactable by phone, (6) clear command of written English (at least Year 5 education), and (7) stable diabetes pharmacotherapy (medication dose stable ≥4 weeks; medication type stable ≥3 months). Study exclusion criteria include (1) 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), (2) current suicidal risk (assessed via suicide risk assessment), (3) significant cognitive disorder (eg, from head trauma or dementia), (4) currently on steroid medication or likely to commence it in the next 12 months, and (5) pregnant or likely to become pregnant in the next 12 months.
All participants are asked to undertake a medical assessment by their general practitioner prior to study enrollment. Individuals with physical limitations or concurrent physical disorders are advised of the need to exercise caution in setting physical activity goals according with their doctor’s advice.
Primary outcomes include diabetes self-care behaviors, HbA1c level, and diabetes-specific distress. Secondary outcomes include depression, anxiety, (medication taking, nutrition intake, physical activity, and blood glucose self-monitoring), quality of life, and user evaluations of the program. Measures are administered at baseline and the 3-, 6-, and 12-month follow-up time points. Table 1 in
Participants register interest on the study website and select a time to undertake an eligibility screening appointment by phone. Eligible individuals undertake baseline measures by email and phone interview at their selected appointment time. Individuals who satisfy all criteria except inclusion criterion time since diagnosis or stable medication are asked if they wish to be recontacted for future screening; if so, they are categorized as “pending.” Individuals who are ineligible are allowed to use the program without being enrolled in the trial.
Following baseline measures, all participants who are randomly allocated to the immediate access or the immediate access plus FIT interventions receive a secure username and password with which to log on to the program. Those enrolled in the delayed access condition are informed that they will receive program access details in 3 months. Computer-generated randomization occurs automatically. One week before the due date for follow-up study measures, participants receive an email notification with a link to the online survey and a preset time for the timeline follow-back procedure phone interview. The email requests that participants email the researcher if the phone interview time does not suit them.
In this condition, participants undertake their usual diabetes care with no Web-based program access. Following 3-month follow-up study measures, they receive access to the full OnTrack Diabetes program. Their access to the program is actioned by a member of the research team after which they receive an email that contains an exclusive username and password to access the program.
Participants receive access to the full OnTrack Diabetes program from baseline as described in the companion paper about the development of OnTrack Diabetes [
In addition to content received in the immediate access condition, participants in this condition receive regular therapist support phone calls wherein FIT techniques are utilized. The therapist is a provisionally registered psychologist who contacts participants twice in the first week of study enrollment and once in the second and third week of enrollment followed by biweekly calls. Calls last for an average of 30 to 40 minutes until the participant has been enrolled for 1 month, after which they last approximately 20 minutes. Participants are encouraged to practice FIT at home every day. The approach assists them to develop and maintain personalized changes to their diabetes self-care behaviors, alcohol use, smoking, or lifestyle. 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.
Preliminary analyses assess for baseline differences and subsequent analyses control for any observed differences. The primary analyses will comprise multiple regressions, predicting posttreatment and follow-up results from baseline measures and treatment contrasts with multiple imputation being used to predict missing data. Mixed-model ANOVAs with repeated measures will also be applied to confirm whether effects are still obtained without imputations. Both methods allow an intention-to-treat approach to the data. Repeated measures ANOVAs will be used to evaluate differences in change scores between the study time points among the 3 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 Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework [
The sample of 210 enables detection of a small effect size of
Ethics approval to conduct this project was granted by the Uniting Care Health Human Research Ethics Committee (#Cassimatis9111) and the Queensland University of Technology Human Research Ethics Committee (#1100000783).
This trial is currently underway with funding support from the Wesley Research Institute in Brisbane, Australia.
Results from this trial will provide information on the efficacy, practicality, and user perspectives on the effects of such a program and the success of its dissemination within the Australian context. A 12-month follow-up period will provide data on the maintenance of effects from the programs as well as patterns of usage over time and the relationship of these variables to study outcomes.
Previous trials of diabetes self-management Web-based programs have indicated that a common limitation of such programs is reduced user engagement over time [
Results will provide information about the effectiveness of using a self-guided approach to a Web-based type 2 diabetes self-management intervention. Limitations to generalizability that commonly affect studies conducted within specific clinical or experimental settings are avoided [
Measures used in trial.
Functional Imagery Training
randomized controlled trial
social cognitive theory
The authors sincerely thank Mitsubishi Development Pty Ltd for their generous support to the Mitsubishi Centre for Rural and Remote Health at the Wesley Research Institute in Brisbane, Australia.
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.