Web-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?’

Abstract

IntroductionPsychological barriers to insulin therapy are associated with the delay of clinically indicated treatment intensification for people with type 2 diabetes (T2D), yet few evidence-based interventions exist to address these barriers. We describe the protocol for a randomised controlled trial (RCT) examining the efficacy of a novel, theoretically grounded, psychoeducational, web-based resource designed to reduce psychological barriers to insulin among adults with non-insulin treated T2D: ‘Is insulin right for me?’.Methods and analysisDouble-blind, parallel group RCT. A target sample of N=392 participants (n=196/arm) will be randomised (1:1) to ‘Is insulin right for me?’ (intervention) or widely available online resources (control). Eligible participants include adults (18–75 years), residing in Australia, currently taking oral hypoglycaemic agents to manage T2D. They will be primarily recruited via invitations and reminders from the national diabetes registry (from a purposefully selected sample of N≥12 000). Exclusion criteria: experience of self-administered injectable; previously enrolled in pilot RCT; ‘very willing’ to start insulin as baseline. Outcomes will be assessed via online survey at 2 weeks and 6 months. Primary outcome between-group: difference in mean negative Insulin Treatment Appraisal Scores (ITAS negative) at 2-week and 6-month follow-up. Secondary outcomes: between-group differences in mean positive insulin appraisals (ITAS positive) and percentage difference in intention to commence insulin at follow-up time points. All data analyses will be conducted according to the intention-to-treat principle.Ethics and disseminationDeakin University Human Research Ethics Committee (2020–073). Dissemination via peer-reviewed journals, conferences and a plain-language summary.Trial registration numberACTRN12621000191897; Australian and New Zealand Clinical Trials Registry.

‘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

“…The registered study protocol (ACTRN12621000191897) is detailed elsewhere, 22 (3) addition of PP analysis.…”

“…A schedule of enrolment, intervention and assessment is detailed in the published protocol. 22 Potential participants were directed to a study website (via Qualtrics™) with basic information and eligibility screening questions, followed by online provision of full study information and consent form. Eligible, consenting, enrolled participants were randomised and invited (via email) to access the allocated web-based resource within a 2week period (with a 1-week reminder).…”

“…The registered study protocol (ACTRN12621000191897) is detailed elsewhere, 22 and was approved by Deakin University Human Research Ethics Committee (reference: 2020–073). A double‐blinded, parallel‐group, two‐arm RCT (1:1 ratio) was conducted, with baseline, 2‐week and 6‐month follow‐up data collection via online survey (hosted by Qualtrics™), and a 2‐week online intervention exposure period.…”

“…A schedule of enrolment, intervention and assessment is detailed in the published protocol 22 . Potential participants were directed to a study website (via Qualtrics™) with basic information and eligibility screening questions, followed by online provision of full study information and consent form.…”

“…The evidence-based intervention development process, and a detailed description of the intervention content, graphic design and behaviour change techniques employed, are published elsewhere. [20][21][22] The intervention homepage includes eight themes, each relating to a known psychological barrier to insulin and framed as a question (See Figure 1). Each barrier was identified via literature search and mapped to the Theoretical Domains Framework (TDF; eight relevant domains: knowledge; skills; social role and identity; beliefs about capabilities; beliefs about consequences; environmental context and resources; social influences; emotion).…”