‘Is insulin right for me?’: Feasibility of a pilot randomised controlled trial and acceptability of a web‐based intervention to reduce psychological barriers to insulin therapy among adults with type 2 diabetes

Holmes‐Truscott, Elizabeth; Holloway, Edith; Husin, Hanafi Mohamad; Furler, John; Hagger, Virginia; Skinner, Timothy; Speight, Jane

doi:10.1111/dme.14759

Cited by 6 publications

(35 citation statements)

References 28 publications

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“…The research team will not have access to NDSS registrants’ details unless they make contact/take part in the study, and the NDSS will not be notified of participating registrants. The total number of invited registrants was selected based on adoption of a conservative response rate of 8%, 37 and an expected 46% translation from consent to enrolled participant (as seen in the pilot RCT 34 ). Invited NDSS registrants will receive an invitation reminder via e-mail or postal mail 2 weeks following first contact.…”

Section: Methods and Analysismentioning

confidence: 99%

“…Using a power analysis for repeated measures analysis of variance, a minimum sample size of N=250 (n=125 per arm) is required to detect a minimally important difference of half a standard deviation (SD=9) in ITAS Negative Scores 39 between study arms with a correlation of 0.65 between repeated measures, at 85% power and 0.05 significance level using a two-sided test. Assuming a 20% attrition rate at 2 weeks 34 and a further 20% attrition at 6 months, the targeted sample size inflates to approximately N=392 (n=196 per arm). Overall, a 40% attrition rate is incorporated into our estimated sample size and replacements will not be made for losses to follow-up.…”

Section: Methods and Analysismentioning

confidence: 99%

“…Inclusion criteria: aged 18 to 75 years; diagnosed with T2D; use of oral hypoglycaemic agents; able to read/write in English and capable of providing informed consent; residing in Australia; access to an internet-enabled computer or tablet device for the duration of the study. Exclusion criteria: diagnoses of diabetes other than T2D; current or prior experience of self-administered injectable treatment for any illness or condition (including diabetes); unable to read/write in English; unable to use/access internet-enabled devices; enrolled as a participant in the pilot RCT 34 ; reports being 'very willing' to initiate insulin therapy (measured using Open access a single-item 'hypothetical willingness' questionnaire 35 ), that is, rendering it impossible to record improvement in this outcome measure.…”

Section: Participants and Recruitmentmentioning

confidence: 99%

“…33 A pilot study demonstrated feasibility of a two-arm randomised controlled trial (RCT) design to test intervention efficacy, compared with widely available online informational resources as well as acceptability of the intervention among adults with T2D. 34 This protocol describes the design of a double-blinded, parallel group, individually RCT (two-arms, 1:1 ratio), comparing 'Is insulin right for me?' (intervention) with widely available online text-based resources about insulin (control) among adults with non-insulin-treated T2D.…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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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?’

et al. 2022

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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.

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Section: Methods and Analysismentioning

confidence: 99%

Section: Methods and Analysismentioning

confidence: 99%

Section: Participants and Recruitmentmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

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?’

et al. 2022

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Supporting people with type 2 diabetes who need insulin

Winkley

2022

Practical Diabetes

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The year 2022 marks 100 years since the first person with diabetes received an insulin injection and supporting people with insulin self‐management is a core role for diabetes nurses. Janet Kinson was a diabetes nurse and author. She developed the first diabetes education programme for nurses and the topic of insulin was central to the curriculum. This article will honour the contribution she made by focusing on diabetes education for people with type 2 diabetes who need insulin. It will start by tracing why and when people with type 2 diabetes should start insulin treatment followed by an exploration of the barriers to starting insulin at the level of the individual, the health care professional and the health system. We know that around 50% of people with type 2 diabetes delay starting insulin for seven years when it is clinically indicated. We also know that around a third of people with type 2 diabetes who are insulin treated remain hyperglycaemic or experience frequent hypoglycaemia. Therefore, there is a need for interventions that address delay, optimise starting insulin as well as consider how we best support people with type 2 diabetes to persist with and intensify their insulin over the diabetes journey. This article presents the current literature on interventions to support people with type 2 diabetes with insulin and identify gaps in support that may be addressed in future research. Copyright © 2022 John Wiley & Sons..

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The experiences of insulin use among older people with Type 2 diabetes mellitus: A thematic synthesis

Langerman

Forbes

Robert

2022

Primary Care Diabetes

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‘Is insulin right for me?’: Feasibility of a pilot randomised controlled trial and acceptability of a web‐based intervention to reduce psychological barriers to insulin therapy among adults with type 2 diabetes

Cited by 6 publications

References 28 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 ‘Is insulin right for me?’

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?’

Supporting people with type 2 diabetes who need insulin

The experiences of insulin use among older people with Type 2 diabetes mellitus: A thematic synthesis

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