None listed
Conditions
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.
Interventions
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 a
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.
Sponsors
Queensland University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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).
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.
Outcome results
None listed