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Trial registered on ANZCTR


Registration number
ACTRN12621000191897
Ethics application status
Approved
Date submitted
10/12/2020
Date registered
23/02/2021
Date last updated
29/11/2021
Date data sharing statement initially provided
23/02/2021
Type of registration
Retrospectively 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 3: Full RCT)
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 3: Full RCT)
Secondary ID [1] 302914 0
SA-2017-11697
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12619001382167 is linked to this trial. ACTRN12619001382167 is the pilot study of this RCT.

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 319944 0
insulin therapy 319945 0
Condition category
Condition code
Metabolic and Endocrine 317881 317881 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] 319210 0
Behaviour
Intervention code [2] 319505 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 two weeks within which they can access the links. Within that timeframe they can view the web resources as many times as they like at their leisure. Data regarding webpage usage/engagement will be collected via self-report.
Control group
Active

Outcomes
Primary outcome [1] 325897 0
The primary outcome measure is the difference in mean negative insulin appraisals, as measured by the Insulin Treatment Appraisal Scale Negative subscale score, between the intervention and control arm at 2-week and 6- month follow-up
Timepoint [1] 325897 0
Baseline, 2 weeks and 6 months post-randomisation/allocation to the intervention or control arm.
Secondary outcome [1] 389463 0
A composite secondary outcome is the immediate and sustained between-arm differences in positive insulin appraisals, as measured using the Insulin Treatment Appraisal Scale (ITAS) Positive subscale.
Timepoint [1] 389463 0
Baseline, 2 weeks and 6 months post-randomisation/allocation to the intervention or control arm.
Secondary outcome [2] 389464 0
A composite secondary outcome is the immediate and sustained between-arm differences in hypothetical willingness to begin insulin therapy, as measured by a single item.
Timepoint [2] 389464 0
Baseline, 2 weeks and 6 months post-randomisation and allocation to the intervention or control arm.
Secondary outcome [3] 391860 0
A process evaluation outcome is the change in diabetes-specific distress, measured using the Problem Areas in Diabetes Scale, at 2-week and 6-month follow up.
Timepoint [3] 391860 0
Baseline, 2 weeks and 6 months post-randomisation and allocation to the intervention or control arm.
Secondary outcome [4] 391861 0
A process evaluation outcome is the change in illness perceptions, measured using the Brief Illness Perceptions Questionnaire, at 2-week and 6-month follow up.
Timepoint [4] 391861 0
Baseline, 2 weeks and 6 months post-randomisation and allocation to the intervention or control arm.
Secondary outcome [5] 391862 0
A process evaluation outcome is the change in diabetes-specific self-efficacy, measured using the Confidence In (type 2) Diabetes Self-management scale, at 2-week and 6-month follow up.
Timepoint [5] 391862 0
Baseline, 2 weeks and 6 months post-randomisation and allocation to the intervention or control arm.
Secondary outcome [6] 391864 0
Diabetes-specific knowledge, measured using Michigan Diabetes Research and Training Center’s Revised Diabetes Knowledge Test, at baseline.
Timepoint [6] 391864 0
Baseline
Secondary outcome [7] 391866 0
Study-specific resource use and acceptability (study specific items) as 2-week follow up
Timepoint [7] 391866 0
2 weeks post-randomisation and allocation to the intervention or control arm.

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 diagnoses 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 diagnoses of diabetes other than T2D (e.g. Type 1, gestational, LADA)
- Use of an injectable diabetes 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
- Enrolled as a participant in the pilot RCT (ACTRN12619001382167).

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 generated via central randomisation by computer and the allocation fully concealed from the investigator, researcher team and participants. Upon randomisation, participants will receive an email from a researcher, independent of the study investigator team and who does not have access to the incoming survey data (except for participant ID, name, gender and email address), specifying access details to their allocated online resource.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation to either the intervention or control arm using randomly permuted block sizes of 4, 6 or 8. Participants will be stratified by gender
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering 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
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to describe participant baseline characteristics and psychological outcomes at each time point. Categorical and binary data will be summarised using counts and proportions, and continuous data using the mean and standard deviation. Where continuous data distributions are skewed, the median and interquartile range will be calculated. Participant characteristics at baseline will be visually assessed for imbalance. The overall characteristics of the study cohort will be compared to those lost to follow-up.

An intention-to-treat (ITT) approach will be adopted whereby participants will be analysed according to the arm they were allocated, and all participants will be included in the analysis. A linear mixed effects model will be used to estimate the difference in mean ITAS negative score between the arms at 2 weeks and 6 months using restricted maximum likelihood estimation. Treatment arm and all three time-points (baseline, 2 weeks and 6 months) will be included as fixed effects in the model. Random effects will be used to account for repeated participant measures. The outcome measure will be adjusted by the stratification factor (gender), as well as age, diabetes duration and education should these be imbalanced between the arms at baseline.

ITAS Positive Scores (secondary outcome) will be analysed using the same modelling approached described above. An ordinal logistic mixed effects model will be used to quantify differences in the willingness to begin insulin therapy (secondary outcome) between the arms at the various time points.
Generalised linear mixed effects models assume any missing data is missing at random. This assumption will be tested in a sensitivity analyses whereby a pattern mixture model will be used to determine whether study conclusions would change should the missing data not be missing at random.

In addition to the primary and secondary outcomes, the following survey data will be examined by study arm for process evaluation purposes:
1. Follow-up clinical discussion and recommendation of insulin therapy, change in medications, and satisfaction with diabetes management
2. Change in psychosocial outcome scores: Diabetes-specific distress (Problem Areas in Diabetes Scale; PAID), illness perceptions (Brief Illness Perception Questionnaire; BIPQ), self-efficacy (Confidence in Diabetes Self-Care Scale; CIDS), single item insulin-specific knowledge items.
3. Diabetes-specific knowledge at baseline (revised Diabetes Knowledge Test; DKT-R)).
4. Resource use and acceptability items as 2-week follow up

In addition, website analytics data will be collected to assess protocol compliance with the intervention resource (proportion of ‘enrolled’ participants who accessed the allocated resource =1 time). Various analytics (e.g. average number of online resource visits; time (minutes) spent on online resource; most commonly (frequency, %) viewed pages) will be examined to explore any relationship(s) between type/duration of content accessed and the study outcomes.

Continuous psychosocial process evaluation outcomes (e.g. PAID,BIPQ, CIDS) will be analysed using the same modelling approached described above.

Descriptive data will be used to explore trends in website analytics, medication changes and clinical discussion of insulin therapy at 6 months separately for each study arm.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/01/2021
Date of last participant enrolment
Anticipated
11/03/2021
Actual
17/03/2021
Date of last data collection
Anticipated
30/09/2021
Actual
4/10/2021
Sample size
Target
520
Accrual to date
Final
479
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 307334 0
Commercial sector/Industry
Name [1] 307334 0
Sanofi-Aventis Australia Pty Ltd (Sanofi)
Country [1] 307334 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] 307974 0
None
Name [1] 307974 0
Address [1] 307974 0
Country [1] 307974 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307423 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 307423 0
Ethics committee country [1] 307423 0
Australia
Date submitted for ethics approval [1] 307423 0
12/03/2020
Approval date [1] 307423 0
14/08/2020
Ethics approval number [1] 307423 0
2020-073

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

Contacts
Principal investigator
Name 107190 0
Dr Elizabeth Holmes-Truscott
Address 107190 0
The Australian Centre for Behavioural Research in Diabetes, 570 Elizabeth Street, Melbourne VIC 3000
Country 107190 0
Australia
Phone 107190 0
+61 3 924 46357
Fax 107190 0
Email 107190 0
etruscott@acbrd.org.au
Contact person for public queries
Name 107191 0
Elizabeth Holmes-Truscott
Address 107191 0
The Australian Centre for Behavioural Research in Diabetes, 570 Elizabeth Street, Melbourne VIC 3000
Country 107191 0
Australia
Phone 107191 0
+61 3 924 46357
Fax 107191 0
Email 107191 0
etruscott@acbrd.org.au
Contact person for scientific queries
Name 107192 0
Elizabeth Holmes-Truscott
Address 107192 0
The Australian Centre for Behavioural Research in Diabetes, 570 Elizabeth Street, Melbourne VIC 3000
Country 107192 0
Australia
Phone 107192 0
+61 3 924 46357
Fax 107192 0
Email 107192 0
etruscott@acbrd.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not intend to use the data collected from this study for any other purpose than that described in this trial application, as per the Participant Plain Language Statement and Consent Form.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9925Study protocol    The study protocol is in preparation for peer-revi... [More Details]
9926Statistical analysis plan    381033-(Uploaded-01-12-2020-22-06-41)-Study-related document.pdf
9927Informed consent form    381033-(Uploaded-01-12-2020-22-07-09)-Study-related document.pdf
9928Ethical approval    381033-(Uploaded-01-12-2020-22-07-43)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseWeb-based intervention to reduce psychological barriers to insulin therapy among adults with non-insulin-treated type 2 diabetes: study protocol for a two-armed randomised controlled trial of 'Is insulin right for me? '.2022https://dx.doi.org/10.1136/bmjopen-2021-051524
Embase'Is Insulin Right for Me?': Web-based intervention to reduce psychological barriers to insulin therapy among adults with non-insulin-treated type 2 diabetes-A randomised controlled trial.2023https://dx.doi.org/10.1111/dme.15117
N.B. These documents automatically identified may not have been verified by the study sponsor.