None listed
Conditions
Brief summary
The next few decades will see a substantial increase in the prevalence of diabetic retinopathy, a common and debilitating microvascular complication of diabetes that progresses largely as a result of poor blood sugar control. Our study responds to the urgent need to assist patients with type 2 diabetes and early diabetic retinopathy to achieve optimal blood sugar control to reduce the risk of irreversible vision loss. We expect our novel personalised routine eye consultation, which is based on evidence-based approaches for behaviour change, to educate and promote long-term behaviour change and lead to clinically significant reductions in blood glucose in a cost effective manner. In this project, we will conduct a randomised controlled trial to investigate the clinical, cognitive and behavioural outcomes of our novel personalised eye consultation model, using the individual’s own retinal images and evidence-based strategies for behavioural change, to motivate and support patients with diabetic retinopathy and poor blood glucose control.
Interventions
Participants are randomised to one of 3 groups. One group will receive a personalised eye consultation followed by 5 follow up support telephone consultations, a second group will receive a personalised eye consulatation (without the follow up support over the phone) and a third (control) group will receive continued access to usual care from their ophthalmologist.
In an in-person consultation, the participant’s own retinal image will be used to explain the status of their diabetic retinopathy
Participants are randomised to one of 3 groups. One group will receive a personalised eye consultation followed by 5 follow up support telephone consultations, a second group will receive a personalised eye consulatation (without the follow up support over the phone) and a third (control) group will receive continued access to usual care from their ophthalmologist. In an in-person consultation, the participant’s own retinal image will be used to explain the status of their diabetic retinopathy and its likely progression in reference to other images of diabetic retinopathy stages. The link between diabetic retinopathy progression, blood glucose control and health behaviours will be explained. The interventionist (an orthoptist, whose major role is to support the ophthalmologist in clinical settings), will then facilitate the participant to set individually tailored goals specifically related to improving blood glucose control (e.g. changes to diet, physical activity). This personalised eye consultation (PEC) is based on HealthChange (trademark) Methodology, developed by Janette Gale with whom we have worked closely in developing our model. This model is a client-centred clinical practice framework grounded in evidence-based psychological theories and principles including Social Cognition Theory, Motivational Interviewing, Solution-focused Counselling, Theory of Planned Behaviour, and the Transtheoretical Model. Our PEC manual outlines a 10-step approach including sample scripts which are tailored to the patients’ existing level of knowledge, motivation and confidence. Based on our pilot work and experience of using the HealthChange (trademark) Methodology, we estimate that the consultation should take 60 - 90 mins. Participants randomised to receive telephone support will receive 5 telephone behaviour change support sessions (in addition ot the personalised eye consultation). These will be delivered at approximately 2, 4, 8, 14 and 20 weeks following the personalised consultation. All behaviour change support sessions will be guided by scripts and are designed to be approximately 15 - 30 minutes in duration. The aim of these sessions is to support the behaviour change processes by prompting additional goal setting, discussing ways to overcome obstacles to health behaviour change and strengthening skills in decision-making, problem-solving and goal planning
Sponsors
Centre for Eye Research Australia (University of Melbourne)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria will be: (a) diagnosis of type 2 diabetes. We have chosen to focus only on type 2 diabetes given the epidemic of type 2 diabetes, and also as most of our public DR patients have this form. Additionally, we wish to keep our sample as homogenous as possible given the natural history and management of type 2 is very different from type 1 diabetes; (b) a score of 20-51 on the Early Treatment Diabetic Retinopathy Study (ETDRS) grading scale suggesting mild to moderate non proliferative diabetic retinopathy; (c) suboptimal HbA1c (greater than or equal to 8%)) at baseline assessment. We chose a conservative 8% cut-off point for our study to reach those in greatest need and to avoid adverse consequences (hypoglycaemia) of tight control; (d) no previous treatment for diabetic retinopathy (e.g., laser or anti-vascular endothelial growth factor) or indication of imminent treatment; (e) at least 18 years old; (f) no cognitive deficit, as assessed by the 6-item cognitive impairment test; (g) ability to communicate in English.
Exclusion criteria
Nil
Outcome results
None listed