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Trial registered on ANZCTR


Registration number
ACTRN12618001191280
Ethics application status
Approved
Date submitted
6/07/2018
Date registered
17/07/2018
Date last updated
13/12/2018
Date data sharing statement initially provided
13/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving diabetes self-care and control in people living with complex diabetes.
Scientific title
Effects of behavioural intervention on adherence to self-care activities,
glycaemic control, diabetes-related psychological distress and quality of life in
adults with complex diabetes.
Secondary ID [1] 295406 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes mellitus 308635 0
Condition category
Condition code
Metabolic and Endocrine 307581 307581 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 301713 0
Behaviour
Comparator / control treatment
Participants will be randomised to start the behavioural intervention either immediately or after a three month extended baseline condition. Comparison will be made within and between the groups.
Control group
Active

Outcomes
Primary outcome [1] 306560 0
Glycaemic control. Measured via serum glycated haemoglobin (HbA1c).
Timepoint [1] 306560 0
3 months [primary timepoint], 6 months, 9 months and 12 months post-intervention.
Secondary outcome [1] 348874 0
Diabetes self-care behaviour. Assessed via a study specific 17-item self-report measure (Perth Diabetes Care Record), indicating frequency of diabetes self-care behaviours over a 14-day period.
Timepoint [1] 348874 0
3 months, 6 months, 9 months and 12 months post-intervention.
Secondary outcome [2] 348975 0
Diabetes-related psychological distress. Measured via the Diabetes Distress Scale (DDS), a 17-item self-report questionnaire.
Timepoint [2] 348975 0
3 months, 6 months, 9 months and 12 months post-intervention.
Secondary outcome [3] 349523 0
Health-related quality of life. Measured via the Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF).
Timepoint [3] 349523 0
3 months, 6 months, 9 months and 12 months post-intervention.

Eligibility
Key inclusion criteria
1. Age 18 years and over.
2. Complex diabetes - either Type 1 OR Type 2 diabetes on insulin for 5 years or more.
3. Suboptimal glycaemic control - recent HbA1c 8.5% or more.
4. Attending dedicated diabetes outpatient clinics at Fiona Stanley or Fremantle Hospitals.
5. Willing to accept randomization, work on behaviour change, and express intent to continue their diabetes care at Fiona Stanley or Fremantle Hospital for next 12months.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Psychiatric diagnosis in the psychotic spectrum (eg. schizophrenia, schizoaffective disorder, depression with psychotic symptoms).
2. Substance dependence.
3. Residing in residential care.
4. Significant cognitive impairment.
5. Intellectual disability.
6. Poor English language fluency.
7. Currently pregnant.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 11330 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 11331 0
Fremantle Hospital and Health Service - Fremantle

Funding & Sponsors
Funding source category [1] 299994 0
Charities/Societies/Foundations
Name [1] 299994 0
Spinnaker Health Research
Address [1] 299994 0
Spinnaker Health Research Foundation
PO Box 480
Fremantle WA 6959
Country [1] 299994 0
Australia
Funding source category [2] 300021 0
Hospital
Name [2] 300021 0
Fiona Stanley and Fremantle Hospital Group
Address [2] 300021 0
11 Robin Warren Drive
Murdoch WA 6150
Country [2] 300021 0
Australia
Primary sponsor type
Individual
Name
Melanie Burkhardt
Address
Department of Endocrinology and Diabetes
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 299376 0
None
Name [1] 299376 0
Address [1] 299376 0
Country [1] 299376 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300849 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 300849 0
Fiona Stanley Hospital
11 Robin Warren Drive
WA 6150
Ethics committee country [1] 300849 0
Australia
Date submitted for ethics approval [1] 300849 0
Approval date [1] 300849 0
26/03/2018
Ethics approval number [1] 300849 0
RGS0000000863

Summary
Brief summary
Poor diabetes-treatment adherence is a major contributor to health complications, avoidable hospitalizations and long-term disease in people living with diabetes. Behavioural intervention is not currently part of standard care to improve adherence to conventional medical and lifestyle regimens for patients with complex diabetes. This research aims to demonstrate how personalised behavioural intervention aimed at increasing diabetes self-care and active coping, can lead to improvements in diabetes control and psychological wellbeing.

The main purposes of this study are to implement and evaluate the effects of a multicomponent behavioural intervention on diabetes treatment adherence and glycaemic control in patients with complex diabetes and suboptimal control, and identify behavioural and contextual factors associated with the response to intervention.

The study aims to demonstrate that:
A. Personalised behavioural intervention will improve glycaemic control in complex patients with sub-optimally controlled diabetes, who are already attending a tertiary diabetes clinic.
B. Improvements in glycaemic control are modulated via increased adherence to treatment.
C. Behavioural intervention reduces diabetes distress and improves quality of life in this complex group of patients.

We aim to recruit 60 participants with either type 1 or type 2 diabetes on insulin, attending dedicated outpatient clinics at Fiona Stanley and Fremantle Hospitals for their diabetes management. All participants will receive behavioural intervention either immediately or following a monitoring period of 3months. Current clinical care will continue unchanged. Clinical outcomes including measures of glycaemic control, psychological distress/wellbeing and quality of life will be evaluated every 3months for up to 1 year following study entry to obtain longer term assessment of study outcomes. During the behavioural intervention component of this study, daily self-monitoring of diabetes self-care behaviour will be obtained via a standardized study diary and questionnaire measures including frequency of diabetes self-care activities, psychological distress/wellbeing, coping and quality of life will be collected at specified intervals for assessment of treatment efficacy. We also plan to undertake a health economic analysis to determine costs and benefits of providing behavioural intervention as part of standard diabetes care. The results of this study will provide a foundation for future work to extend this behavioural intervention model to optimize care in the wider population living with diabetes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85026 0
Dr Melanie Burkhardt
Address 85026 0
Department of Endocrinology and Diabetes
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch, WA, 6150
Country 85026 0
Australia
Phone 85026 0
+61861522222
Fax 85026 0
Email 85026 0
Melanie.Burkhardt@health.wa.gov.au
Contact person for public queries
Name 85027 0
Dr Melanie Burkhardt
Address 85027 0
Department of Endocrinology and Diabetes
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch, WA, 6150
Country 85027 0
Australia
Phone 85027 0
+61861522222
Fax 85027 0
Email 85027 0
Melanie.Burkhardt@health.wa.gov.au
Contact person for scientific queries
Name 85028 0
Dr Melanie Burkhardt
Address 85028 0
Department of Endocrinology and Diabetes
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch, WA, 6150
Country 85028 0
Australia
Phone 85028 0
+61861522222
Fax 85028 0
Email 85028 0
Melanie.Burkhardt@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results