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Trial registered on ANZCTR


Registration number
ACTRN12619001382167
Ethics application status
Approved
Date submitted
15/09/2019
Date registered
10/10/2019
Date last updated
17/03/2020
Date data sharing statement initially provided
10/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Development, Feasibility, and Efficacy of a Web-Based Intervention to Reduce Psychological Barriers to Insulin Therapy among Adults with Type 2 Diabetes (Stage 2: Pilot Study)
Scientific title
Development, Feasibility, and Efficacy of a Web-Based Intervention to Reduce Psychological Barriers to Insulin Therapy among Adults with Type 2 Diabetes (Stage 2: Pilot Study)
Secondary ID [1] 299290 0
Sanofi-Aventis Australia Pty Ltd (Sanofi; sponsor-issued trial number SA-2017-11697)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 314418 0
Insulin therapy 314419 0
Condition category
Condition code
Metabolic and Endocrine 312762 312762 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group participants will receive access to the novel psycho-educational website. The website will provide content on 8 key barriers (concerns/questions) that adults with type 2 diabetes have about starting insulin therapy, identified by conducting a review of the literature. The 8 barriers include: 1) Does insulin therapy mean that my diabetes is more serious; 2) Does insulin therapy cause diabetes-related complications; 3) Will I gain weight if I inject insulin; 4) Is it my fault that I need insulin injections; 5) Will injecting hurt; 6) Does injecting insulin increase my risk of hypoglycaemia; 7) What will others think of me if I inject insulin; and 8) Is injecting insulin a burden. This includes content which maps onto commonly reported negative attitudes toward insulin among Australians with T2D, as measured by the widely used and validated Insulin Treatment Appraisal Scale (ITAS). The website content, structure and key messaging will be informed by behaviour change theory and incorporate relevant behaviour changes techniques with appropriate methods of application (e.g. text, quizzes, videos). For example, quotes and video messages from people with diabetes to normalise beliefs and attitudes; improve expectations about future insulin use, as well as modelling positive self-care behaviours and improving self-efficacy through observational learning. Participants in the intervention arm will have 2 weeks to access the web-based intervention. They resource is self-paced so that within the 2-week period participants may choose to read the content that is of relevance/interest to them. Using Google analytics, we will track each participants usage on the website including, how many times they access the resource, how long they spend on the resource and also each page, what pages they view.
Intervention code [1] 315567 0
Behaviour
Intervention code [2] 315675 0
Treatment: Other
Comparator / control treatment
Control arm participants will be directed to a static webpage including links to publications about insulin therapy which are currently available online to Australians with T2D. Specifically, the website will include text-based factsheets about insulin and other T2D medications published by the National Diabetes Services Scheme (NDSS): “Medication for type 2 diabetes”, “Insulin and type 2 diabetes”. Participants will have a two weeks within which they can access the links. Within that timeframe they can logon as many times as they like.cUsing Google analytics, we will track each participants usage on the website including, how many times they access the links and what factsheets they navigate to.
Control group
Active

Outcomes
Primary outcome [1] 321387 0
Feasibility (via recruitment and retention rates, and protocol compliance) of a two-armed randomised controlled trial (RCT) design using online enrolment, participation and data collection to evaluate the efficacy of a novel psycho-educational insulin therapy web-based resource.
Timepoint [1] 321387 0
Baseline and 2 weeks post-randomisation
Secondary outcome [1] 374840 0
To determine the acceptability of the intervention content and format for people with non-insulin-treated T2D via (1) website usage data, (2) detailed qualitative and quantitative survey feedback from participants about their experiences of intervention to inform future developments.
Timepoint [1] 374840 0
2 weeks post-randomisation
Secondary outcome [2] 374841 0
Change in insulin appraisals at follow-up as assessed by the Insulin Treatment Appraisal Scale: ITAS
Timepoint [2] 374841 0
Baseline and 2 weeks post-randomisation
Secondary outcome [3] 374842 0
Change in in diabetes-specific knowledge at follow-up as assessed by the Michigan Diabetes Research and Training Center’s Revised Diabetes Knowledge Test: DKT-R
Timepoint [3] 374842 0
Baseline and 2 weeks post-randomisation
Secondary outcome [4] 374843 0
Change in willingness to commence insulin therapy at follow-up using a single 'hypothetical willingness to commence insulin' item developed by Polonsky and colleagues.

William H. Polonsky, Tibor R.S. Hajos, Marie-Paule Dain & Frank J. Snoek (2011) Are patients with type 2 diabetes reluctant to start insulin therapy? An examination of the scope and underpinnings of psychological insulin resistance in a large, international population, Current Medical Research and Opinion, 27:6, 1169-1174.
Timepoint [4] 374843 0
Baseline and 2 weeks post-randomisation

Eligibility
Key inclusion criteria
Each participant must meet all of the following criteria, as self-reported, to be enrolled in this study:
- Aged 18 to 75 years at the time of randomisation
- Self-reported diagnosis of T2D
- Currently using oral hypoglycaemic agents for the treatment of T2D
- Able to read/write in English and capable of understanding the informed consent document and provide consent
- Residing in Australia at the time of randomisation and throughout the study period
- Access to an internet-enabled device (i.e. computer, tablet) for the duration of the study.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants meeting any of the following criteria will be excluded from the study:
- Self-reported diagnosis of diabetes other than T2D (e.g. Type 1, gestational, LADA)
- Current (or in the past) use of an injectable medication (i.e. GLP-1 agonist, insulin) at the time of randomisation
- Prior experience of self-administered injectable treatment for any illness or condition
- Unable to read/write in English
- Unable to use/access internet-enabled devices (i.e. computer, tablet) during the study period
- Reports being “very willing” to initiate insulin therapy (measured using a single-item “hypothetical willingness” questionnaire), i.e. rendering it impossible to record improvement in this outcome measure.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation sequence will be computer generated and the allocation fully concealed from the investigator, researcher team and participants. A research assistant independent to the study will notify participants of their group assignment via e-mail.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated to one of two groups, on an equal allocation basis, stratified by gender. The randomisation sequence will be computer generated using block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size estimation: No sample size calculation is required for a pilot study. However, a minimum sample size of at least 20 participants (10 per trial arm) is recommended by Cocks and colleagues. A sample size of 40 eligible consenting participants will be recruited and enrolled, allowing generously for up to 50% attrition. This inflated sample will ensure that a minimum sample size of N=20 is reached and provide opportunity to assess actual rates of loss to follow-up, protocol compliance and data completeness to inform the main RCT sample size calculation.
Analysis plan: This pilot study is not designed nor powered for testing the significance of change in negative insulin appraisals, strength of association between the intervention, compared to the control, or inferring causality between dependent and independent variables. Using quantitative data, descriptive statistics (frequencies, proportions, measures of central tendency) will be used to explore and describe the feasibility and acceptability of assessment outcomes. A crude estimate for the association between the intervention and ITAS negative scores will be examined using an unadjusted analysis of covariance (ANCOVA). The underlying assumptions of ANCOVA will be assessed where possible: scatter plots for linearity of relationship between baseline and post-intervention ITAS negative score, the Kolmogorov-Smirnov test and normal probability plots for normality of continuous variables and residuals, residual-vs-fitted plots for homoscedasticity of error variance and DFBETA plots for influential observations or outliers.
For the qualitative data, thematic analyses will be used to explore, and identify key themes, from free-text responses about participant’s experiences of the resources to inform future developments.

Cocks K, Torgerson DJ. Sample size calculations for pilot randomized trials: a confidence interval approach. Journal of clinical epidemiology. 2013;66(2):197-201.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/10/2019
Actual
31/10/2019
Date of last participant enrolment
Anticipated
29/11/2019
Actual
1/12/2019
Date of last data collection
Anticipated
13/12/2019
Actual
17/12/2019
Sample size
Target
40
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303816 0
Commercial sector/Industry
Name [1] 303816 0
Sanofi-Aventis Australia Pty Ltd (Sanofi)
Country [1] 303816 0
Australia
Primary sponsor type
Other
Name
The Australian Centre for Behavioural Research in Diabetes
Address
570 Elizabeth Street, Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 303940 0
None
Name [1] 303940 0
Address [1] 303940 0
Country [1] 303940 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304330 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 304330 0
Ethics committee country [1] 304330 0
Australia
Date submitted for ethics approval [1] 304330 0
28/06/2019
Approval date [1] 304330 0
03/09/2019
Ethics approval number [1] 304330 0
2019-253

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

Contacts
Principal investigator
Name 96566 0
Dr Elizabeth Holmes-Truscott
Address 96566 0
The Australian Centre for Behavioural Research in Diabetes, 570 Elizabeth Street, Melbourne VIC 3000
Country 96566 0
Australia
Phone 96566 0
+61 3 924 46357
Fax 96566 0
Email 96566 0
[email protected]
Contact person for public queries
Name 96567 0
Elizabeth Holmes-Truscott
Address 96567 0
The Australian Centre for Behavioural Research in Diabetes, 570 Elizabeth Street, Melbourne VIC 3000
Country 96567 0
Australia
Phone 96567 0
+61 3 924 46357
Fax 96567 0
Email 96567 0
[email protected]
Contact person for scientific queries
Name 96568 0
Elizabeth Holmes-Truscott
Address 96568 0
The Australian Centre for Behavioural Research in Diabetes, 570 Elizabeth Street, Melbourne VIC 3000
Country 96568 0
Australia
Phone 96568 0
+61 3 924 46357
Fax 96568 0
Email 96568 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


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4798Ethical approval    378377-(Uploaded-15-09-2019-22-03-27)-Study-related document.pdf
4799Study protocol    378377-(Uploaded-15-09-2019-22-05-06)-Study-related document.pdf
4800Statistical analysis plan    378377-(Uploaded-15-09-2019-22-05-56)-Study-related document.pdf


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4798Ethical approval    378377-(Uploaded-15-09-2019-22-03-27)-Study-related document.pdf
4799Study protocol   
4800Statistical analysis plan   

Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
Embase'Is Insulin Right for Me?' Development of a theory-informed, web-based resource for reducing psychological barriers to insulin therapy in type 2 diabetes.2021https://dx.doi.org/10.1136/bmjopen-2020-045853
Embase'Is insulin right for me?': Feasibility of a pilot randomised controlled trial and acceptability of a web-based intervention to reduce psychological barriers to insulin therapy among adults with type 2 diabetes.2022https://dx.doi.org/10.1111/dme.14759
N.B. These documents automatically identified may not have been verified by the study sponsor.