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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 3: Full RCT)

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)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000191897
Enrollment
479
Registered
2021-02-23
Start date
2021-01-12
Completion date
2021-03-17
Last updated
2021-12-06

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

Conditions

None listed

Brief summary

It is estimated that approximately 1.1 million Australians are living with type 2 diabetes (T2D). T2D is characterised by high blood glucose (hyperglycaemia). Prolonged hyperglycaemia increases the risk of developing diabetes-related complications. Managing T2D can involve healthy eating, regular, physical activity, maintaining a healthy weight and taking diabetes medications. These behaviours are all important for maintaining blood glucose levels within the recommended target range. T2D is a progressive condition which means that the type (and/or dose) of medication a person needs to keep their blood glucose levels in target range may change over time. Injecting insulin is a very effective treatment for diabetes. However, around one quarter of adults with T2D report being not at all willing to inject insulin if recommended by their health professional. People with T2D commonly report concerns and negative attitudes about insulin therapy, including a belief that insulin is not effective for T2D, and could negatively affect a person’s health; concerns about injecting insulin, and; feelings of guilt and self-blame about what insulin symbolises about their health and identity. Our research has previously shown that around half of Australians with non- insulin-treated T2D believe that insulin is a punishment or consequence of ‘failing’ to self-manage their diabetes previously. These negative attitudes about insulin are associated with delayed commencement of insulin. Few resources are currently available to people with T2D to help address these negative attitudes about insulin. Existing Australian resources about insulin are not evidence- based and have not been evaluated to test whether they reduce these negative attitudes. Given the size of the Australian population with T2D a resource that is delivered online to enable wide reach is needed. Therefore, this study aims to test if a novel web-based resource (intervention), compared to widely available existing resources (control), is effective for reducing negative attitudes toward insulin therapy, among adults with non-insulin-treated T2D.

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, Caregiver, 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 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

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).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 13, 2026