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. 2022 Feb 21;12(2):e051524.
doi: 10.1136/bmjopen-2021-051524.

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?'

Elizabeth Holmes-Truscott  1   2 , Edith E Holloway  3   2 , Hanafi M Husin  3   2 , John Furler  4 , Virginia Hagger  5 , Timothy C Skinner  6   7 , Jane Speight  3   2
Affiliations

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?'

Elizabeth Holmes-Truscott et al. BMJ Open. .

Abstract

Introduction: Psychological 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 analysis: Double-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 dissemination: Deakin University Human Research Ethics Committee (2020-073). Dissemination via peer-reviewed journals, conferences and a plain-language summary.

Trial registration number: ACTRN12621000191897; Australian and New Zealand Clinical Trials Registry.

Keywords: clinical trials; diabetes & endocrinology; social medicine.

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Conflict of interest statement

Competing interests: EH-T has undertaken research funded by an unrestricted educational grant from Abbott Diabetes Care, AstraZeneca, and Sanofi; received speaker fees from Novo Nordisk and Roche to Australian Centre for Behavioural Research in Diabetes (ACBRD); and served on an advisory board for AstraZeneca. EEH has no conflicts of interest to disclose. JF has received unrestricted educational grants for research support from Roche, Sanofi, and Medtronic. TS serves on advisory boards for Novo Nordisk and Liva Health Care and is currently on a EIT Health research grant held jointly with Roche Diagnostics. JS has served on advisory boards for Janssen, Medtronic, Roche Diabetes Care, and Sanofi Diabetes; her research group (Australian Centre for Behavioural Research in Diabetes [(ACBRD])) has received honoraria for this advisory board participation and has also received unrestricted educational grants and in-kind support from Abbott Diabetes Care, AstraZeneca, Medtronic, Roche Diabetes Care, and Sanofi Diabetes. JS has also received sponsorship to attend educational meetings from Medtronic, Roche Diabetes Care, and Sanofi Diabetes, and consultancy income or speaker fees from Abbott Diabetes Care, AstraZeneca, Medtronic, Novo Nordisk, Roche Diabetes Care, and Sanofi Diabetes. All other authors have no conflicts of interest to declare.

Figures

Figure 1.
Figure 1.
Schedule of enrolment, interventions, and assessments. a—Compulsory questions for participation. b—Co-morbidities included: kidney disease, retinopathy, neuropathy, heart disease, stroke, vascular disease, sexual dysfunction, other (to be specified). HbA1c, haemoglobin A1C; NDSS; National Diabetes Services Scheme.
See this image and copyright information in PMC

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