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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)

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)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001382167
Enrollment
35
Registered
2019-10-10
Start date
2019-10-31
Completion date
2019-12-01
Last updated
2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Insulin therapy is the most effective treatment for diabetes, however, one in four adults with type 2 diabetes (T2D) delay initiation due to negative attitudes towards insulin. Few evidence-based interventions exist to address these issues and none widely available in Australia. The aim of this study is to pilot-test the efficacy of a novel psycho-educational web-based resource for reducing negative attitudes to insulin among adults with non-insulin treated T2D. A two-armed pilot randomised controlled trial will be conducted to assess the feasibility and acceptability of the intervention content and format. Up to 40 adults with non-insulin treated T2D will be recruited through the ACBRD (and affiliated organisations) websites, e-newsletters/blogs and social media. Preliminary evidence for the effectiveness of the web-based resource (intervention) compared to widely available existing resources (control) in reducing negative attitudes towards insulin will also be investigated. Outcomes will be assessed at baseline and 2-week follow-up.

Interventions

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.

Sponsors

The Australian Centre for Behavioural Research in Diabetes
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026