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Lookup NU author(s): Professor James Shaw
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© The Author(s) 2024. Background : Management of type 1 diabetes (T1D) requires the use of insulin, which can cause hypoglycaemia (low blood glucose levels). While most hypoglycaemic episodes can be self-treated, all episodes can be sudden, inconvenient, challenging to prevent or manage, unpleasant and/or cause unwanted attention or embarrassment. Severe hypoglycaemic episodes, requiring assistance from others for recovery, are rare but potentially dangerous. Repeated exposure to hypoglycaemia can reduce classic warning symptoms (‘awareness’), thereby increasing risk of severe episodes. Thus, fear of hypoglycaemia is common among adults with T1D and can have a negative impact on how they manage their diabetes, as well as on daily functioning, well-being and quality of life. While advances in glycaemic technologies and group-based psycho-educational programmes can reduce fear, frequency and impact of hypoglycaemia, they are not universally or freely available, nor do they fully resolve problematic hypoglycaemia or associated worries. This study aims to determine the effectiveness of a fully online, self-directed, scalable, psycho-educational intervention for reducing fear of hypoglycaemia: the Hypoglycaemia Prevention, Awareness of Symptoms, and Treatment (HypoPAST) programme. Methods: A 24-week, two-arm, parallel-group, hybrid type 1 randomised controlled trial, conducted remotely (online and telephone). Australian adults (≥ 18 years) with self-reported T1D and fear of hypoglycaemia will be recruited, and allocated at random (1:1) to HypoPAST or control (usual care). The primary outcome is the between-group difference in fear of hypoglycaemia (assessed using HFS-II Worry score) at 24 weeks. A sample size of N = 196 is required to detect a 9-point difference, with 90% power and allowing for 30% attrition. Multiple secondary outcomes include self-reported psychological, behavioural, biomedical, health economic, and process evaluation data. Data will be collected at baseline, 12 and 24 weeks using online surveys, 2-week ecological momentary assessments, website analytics and semi-structured interviews. Discussion: This study will provide evidence regarding the effectiveness, cost-effectiveness and acceptability of a novel, online psycho-educational programme: HypoPAST. Due to the fully online format, HypoPAST is expected to provide an inexpensive, convenient, accessible and scalable solution for reducing fear of hypoglycaemia among adults with T1D. Trial registration: Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12623000894695 (21 August 2023).
Author(s): Halliday JA, Holmes-Truscott E, Thuraisingam S, Soholm U, Chatterton ML, Russell-Green S, O E, Andrikopoulos S, Black T, Davidson S, Noonan G, Scibilia R, Hagger V, Hendrieckx C, Mihalopoulos C, Shaw JAM, Versace VL, Zoungas S, Skinner TC, Speight J, Robinson A, Prasertsung C, Baptista S
Publication type: Article
Publication status: Published
Journal: Trials
Year: 2024
Volume: 25
Online publication date: 29/10/2024
Acceptance date: 14/10/2024
Date deposited: 12/11/2024
ISSN (electronic): 1745-6215
Publisher: BioMed Central Ltd
URL: https://doi.org/10.1186/s13063-024-08556-1
DOI: 10.1186/s13063-024-08556-1
Data Access Statement: In the first instance, following database-lock, only the HypoPAST research group members responsible for data management or data analysis will have access to the de-identified data. Following publication of the findings, survey metadata will be placed in an open-access data repository (Deakin Research Data Store (RDS)), with conditional access to the de-identified dataset available to other researchers upon reasonable request. Data will be shared in a de-identified format if the Project Manager and Lead Investigator are satisfied with both the rationale for the request and how the data will be stored and used; and if researchers are willing to sign a Data Sharing Agreement documenting how they intend to use transfer, store and dispose of the data.
PubMed id: 39468682
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