Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000905965
Ethics application status
Approved
Date submitted
28/05/2020
Date registered
14/09/2020
Date last updated
3/04/2024
Date data sharing statement initially provided
14/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the effectiveness and acceptability of a short, individualized diabetes self-management program that targets active coping skills, for adults aged 18 to 50 years with type 1 diabetes.
Scientific title
A pilot behavioural intervention targeting diabetes self-management and active coping skills for adults with type 1 diabetes: exploring pathways to psychological and glycaemic outcomes.
Secondary ID [1] 298868 0
Nil known
Universal Trial Number (UTN)
U1111-1237-7190
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 313824 0
Diabetes distress
 313826 0
Psychological flexibility 313828 0
Mental health 313829 0
Condition category
Condition code
Metabolic and Endocrine 312229 312229 0 0
Diabetes
Mental Health 312230 312230 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a Conjoint Behavioural Consultation Model design, to target diabetes self-management knowledge and behaviours, with input from a consultant (clinical psychologist with extensive experience working with people with diabetes), consultee (experienced diabetes nurse educator) and the individual participant with type 1 diabetes. The intervention requires 6 individual (up to 1 hour) sessions over approximately 8 weeks, via a combination of face to face and remote/ virtual visits. After the intervention phase, there is one follow up visit at 3 months and again at 6 months.
Data collection includes self-reported diabetes self-management actions, surveys and clinical measures such as glycated hemoglobin.
Principles of diabetes self-management education and behavioural psychology will guide the intervention, that will target active coping and positive diabetes self-management behaviours with the aim of improving diabetes related health outcomes.
Intervention code [1] 315134 0
Behaviour
Comparator / control treatment
Participants will act as their own control, as per a 'single case research methods' design (baseline / intervention phase / return to baseline phase).
Standard care (i.e. outpatient diabetes clinic appointments) will continue while participants are enrolled in this pilot study.
Various process and glycaemic measures will be assessed at baseline, then re-assessed at 3 months and 6 months post the intervention phase to measure any lasting effects from the intervention.
Control group
Active

Outcomes
Primary outcome [1] 320877 0
Individual diabetes self-management will be assessed with a self-reported questionnaire and participant log book. Historical data from glucometer or insulin pump will also be uploaded to obtain further glucose and insulin data.
Timepoint [1] 320877 0
Measured at baseline, end of intervention, 3 months and 6 months post intervention
Primary outcome [2] 320887 0
Time in target glucose range will be measured, where possible, with participants own glucose sensor data.
Timepoint [2] 320887 0
Data from participants own continuous glucose sensor will be requested, where possible, at baseline, end of intervention and 6 months.
Secondary outcome [1] 373210 0
Diabetes distress will be measured using a validated diabetes distress scale (T1-DDS)
Timepoint [1] 373210 0
Measured at baseline, end of intervention, 3 months and 6 months post intervention
Secondary outcome [2] 373212 0
Glycated haemoglobin will be assessed via laboratory (serum assay) or point of care test.
Timepoint [2] 373212 0
Baseline, end of intervention and end of study (6 months)

Eligibility
Key inclusion criteria
1. Diagnosis of type 1 diabetes for at least 12 months
2. Aged 18 to 50 years.
3. Glycated haemoglobin within the previous 6 months > 8% And/ OR clinically significant diabetes distress score
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy or breastfeeding
2. Non-English speaking
3. A level of disability that prevents independence in diabetes self-management.
4. A psychiatric disorder which in the opinion of the researchers would preclude participation in the intervention.
5. Inability to adhere to the protocol and study visits.
6. Use of Psychotropic medication will not automatically be an exclusion criteria, if the dosage has been stable for the past 3 months and will continue to be stable during the intervention period. Any changes in medication during the study period will be noted along with the other measurements at all stages.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Single case research methods, using a reversal design (ABA pattern). This design involves a sequence of experimental conditions from non - intervention (A) to an intervention phase (B) and then back to a non-intervention phase (A).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Single case research design allows assessment of the effects of the independent variable on the outcome measures, via intra-subject replication. The mechanism for measuring outcomes is through replications within the same participant (intra-subject), and across participants (inter-subject), with multiple data points. Individual participants are compared with themselves under the experimental conditions. Clinical significance is measured to demonstrate treatment effectiveness, determined by: effect size, visual/graphical inspection of data, process measures, measures of social validation.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
25/09/2020
Actual
20/11/2020
Date of last participant enrolment
Anticipated
1/11/2023
Actual
11/05/2023
Date of last data collection
Anticipated
31/05/2024
Actual
Sample size
Target
40
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 14344 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 27347 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 305825 0
University
Name [1] 305825 0
University of Western Australia
Country [1] 305825 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Highway, Crawley.
Perth, Western Australia, Australia, 6009.
Country
Australia
Secondary sponsor category [1] 306249 0
None
Name [1] 306249 0
N/A
Address [1] 306249 0
N/A
Country [1] 306249 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303944 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 303944 0
Ethics committee country [1] 303944 0
Australia
Date submitted for ethics approval [1] 303944 0
31/10/2019
Approval date [1] 303944 0
11/12/2019
Ethics approval number [1] 303944 0
RGS3290

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95330 0
Ms Jennifer Nicholas
Address 95330 0
Harry Perkins Institute of Medical Research
5 Robin Warren Dr, Murdoch WA 6150
Country 95330 0
Australia
Phone 95330 0
+61 0428404086
Fax 95330 0
Email 95330 0
[email protected]
Contact person for public queries
Name 95331 0
Jennifer Nicholas
Address 95331 0
Harry Perkins Institute of Medical Research
5 Robin Warren Dr, Murdoch WA 6150
Country 95331 0
Australia
Phone 95331 0
+61 0428404086
Fax 95331 0
Email 95331 0
[email protected]
Contact person for scientific queries
Name 95332 0
Jennifer Nicholas
Address 95332 0
Harry Perkins Institute of Medical Research
5 Robin Warren Dr, Murdoch WA 6150
Country 95332 0
Australia
Phone 95332 0
+61 0428404086
Fax 95332 0
Email 95332 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be shared for this pilot study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.