Hypoglycaemia Prevention, Awareness of Symptoms, and Treatment (HypoPAST): protocol for a 24-week hybrid type 1 randomised controlled trial of a fully online psycho-educational programme for adults with type 1 diabetes.

Humans Diabetes Mellitus, Type 1 / psychology Hypoglycemia / prevention & control Patient Education as Topic / methods Randomized Controlled Trials as Topic Health Knowledge, Attitudes, Practice Time Factors Adult Fear Hypoglycemic Agents / therapeutic use Treatment Outcome Awareness Blood Glucose / metabolism Quality of Life Glycemic Control Insulin Internet-Based Intervention

Fear of hypoglycaemia Hypoglycaemia Psycho-educational training Type 1 diabetes

Journal

Trials

ISSN: 1745-6215

Titre abrégé: Trials

Pays: England

ID NLM: 101263253

Informations de publication

Date de publication:
29 Oct 2024

Historique:

received: 23 08 2024

accepted: 14 10 2024

medline: 29 10 2024

pubmed: 29 10 2024

entrez: 29 10 2024

Statut: epublish

Résumé

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. 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. 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. Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12623000894695 (21 August 2023).

Sections du résumé

BACKGROUND BACKGROUND

METHODS 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 CONCLUSIONS

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 BACKGROUND

Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12623000894695 (21 August 2023).

Identifiants

DOI: 10.1186/s13063-024-08556-1 PMID: 39468682

pubmed: 39468682

doi: 10.1186/s13063-024-08556-1

pii: 10.1186/s13063-024-08556-1

doi:

Substances chimiques

Hypoglycemic Agents 0

Blood Glucose 0

Insulin 0

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

Pagination

725

Investigateurs

Shaira Baptista (S)

Chatpakorn Prasertsung (C)

Alison Robinson (A)

Informations de copyright

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