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 ''

Overview

Journal BMJ Open

Specialty General Medicine

Date 2022 Feb 22

PMID 35190420

Authors

Elizabeth Holmes-Truscott

Edith E Holloway

Hanafi M Husin

John Furler

Virginia Hagger

Timothy C Skinner

Jane Speight

Affiliations

Soon will be listed here.

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: '.

Methods And Analysis: Double-blind, parallel group RCT. A target sample of N=392 participants (n=196/arm) will be randomised (1:1) to ' (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.

Citing Articles

Low-Intensity mental health Support via a Telehealth Enabled Network for adults with diabetes (LISTEN): protocol for a hybrid type 1 effectiveness implementation trial.

Holloway E, Gray S, Mihalopoulos C, Versace V, Le Gautier R, Chatterton M Trials. 2023; 24(1):350.

PMID: 37221629 PMC: 10204211. DOI: 10.1186/s13063-023-07338-5.

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