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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? '

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posted on 03.06.2022, 02:14 authored by E Holmes-Truscott, EE Holloway, HM Husin, J Furler, V Hagger, Timothy SkinnerTimothy Skinner, J Speight
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.

Funding

This work was supported by an instigator-sponsored-study grant from Sanofi-Aventis Australia Pty Ltd (Sanofi). Sanofi was not involved in the study design and will not be involved in the collection, analysis or interpretation of the study data, but was given the opportunity to view the manuscript prior to submission. The decision to submit for publication was made independently by the authors. Sanofi will be allowed access to all de-identified data from the study for research and audit purposes, if requested. Costs associated with participation incentives, website development and data management were funded (in full, or partially) by the Australian Centre for Behavioural Research in Diabetes (ACBRD). In--kind support including project oversight was provided by the Investigator team. JS is supported by the core funding to the ACBRD provided by the collaboration between Diabetes Victoria and Deakin University. EHT was supported by the same plus a Deakin University Deans Research Postdoctoral Fellowship (2018--2020).

History

Publication Date

21/02/2022

Journal

BMJ Open

Volume

12

Issue

2

Article Number

ARTN e051524

Pagination

9p.

Publisher

BMJ

ISSN

2044-6055

Rights Statement

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non- commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non- commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.