Improving diabetes self-care and control in people living with complex diabetes.

This study utilises an intra-subject replication design with random allocation of participants to two comparison conditions - (A) immediate or (B) delayed start (extended baseline). All participants will receive behavioural intervention. The multicomponent behavioural intervention utilised in this study is based on well-established, scientifically derived Applied Behaviour Analysis (ABA) principles, which will be delivered one to one via a behavioural consultation approach, in 9 sessions of 60 minute duration over a 12 week period. The coordinating principal investigator (a clinical psychologist) will deliver the intervention in dedicated multidisciplinary outpatient diabetes clinics at two tertiary hospital sites. The intervention comprises the following three phases: 1. Baseline (session 1) – Involves orientation to the intervention, its rationale and approach to facilitating behaviour change, and that the goal of behavioural consultation is specifically to improve diabetes self-care behaviours. Participants will be required to undertake daily self-monitoring which involves collecting the daily study measures consisting of key diabetes self-management behaviour/s over a 2-week period. There will be no planned contact from the trial clinical psychologist during this 2-week self-monitoring period. 2. Active intervention (sessions 2 - 8) - Immediately following the baseline self-monitoring period, the participant attends their first behavioural consultation session (session 2). Participants will attend a total of 7x weekly, one to one collaborative behavioural consultation sessions. The structured intervention consists of 4 stages - (1) problem identification, (2) functional and contextual analysis to inform behavioural strategies, (3) plan implementation and (4) evaluation of strategies. The trial clinical psychologist will provide instruction and identify opportunities with the aim of developing the following self-management skills - (i) defining problems, (ii) strategies for classifying conditions that potentially influence behaviour (ie. antecedent, consequent and sequential conditions, and the function they may serve) and (iii) to solve behavioural problems in context. The sessions are structured to begin with; (A) a review of the preceding week (ie. self-care behaviour including measures of frequency and/or duration, and/or plan implementation), (B) assessment of problem behaviour/presenting concern with aim of formulating hypotheses regarding behavioural function to inform behaviour change strategies, (C) an educational component (ie. behaviour change principles based on ABA), (D) goal and/or objective setting and (E) development of an implementation plan. The participant is invited to continue recording daily self-care activities in the study diary, which will be reviewed and discussed at each session. The trial clinical psychologist will review the individual’s diabetes self-care behaviour utilising self-monitored data from the study diary and objective data from personal devices (ie. glucometer, continuous blood glucose monitoring or insulin pump device data), and provide verbal and visual feedback (via graphed trends) on performance, and where relevant praise on goal attainment and/or effort will be provided. All participants will have set a specific goal and associated weekly objectives, with an agreed action plan with the aim of incrementally improving one or more key diabetes-related self-care behaviours for the duration of the active phases of the intervention. At the weekly behavioural consultation sessions, the integrity with which the participant has applied the intervention strategies will also be assessed. 3. Maintenance (session 9): The intervention components taught during the active intervention (sessions 2 – 8) are self-managed by the individual participant, with no contact from the trial clinical psychologist for a period of 4 weeks. The participant is invited to continue recording daily self-care activities in the study diary during this period. A review is conducted at the end of the 4 weeks to discuss with the participant their progress relating to their diabetes self-care and their coping including potential setbacks. The focus of consultation will be to assess the individual participants’ self-management of the behavioural intervention strategies, provide opportunity to troubleshoot and consolidate learning and skills, and develop plan for longer-term maintenance and relapse prevention. All participants will continue to receive standard diabetes care via the multidisciplinary diabetes team within the Departments of Endocrinology and Diabetes at Fiona Stanley and Fremantle Hospitals.