Dataset Information

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:

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.

SUBMITTER: Holmes-Truscott E

PROVIDER: S-EPMC8862461 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

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Publications

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 '<i>Is insulin right for me?</i>'.

Holmes-Truscott Elizabeth E Holloway Edith E EE Husin Hanafi M HM Furler John J Hagger Virginia V Skinner Timothy C TC Speight Jane J

BMJ open 20220221 2

<h4>Introduction</h4>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 tre ...[more]

PMID: 35190420

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