None listed
Conditions
Brief summary
People with type 1 diabetes (T1D) need insulin for survival but hypoglycaemia (low blood glucose, also called ‘hypo’) is a common side effect. Untreated hypos can cause confusion, injury, coma, and sudden death. Living with the risk of hypo impairs mental health. For example 75% of people with T1D have mild fear of hypo and 25% have severe diabetes distress. Fear of hypo drives misguided coping strategies (e.g. skipping insulin or maintaining glucose above target), which increases risk for long-term health complications. HypoPAST (Hypoglycaemia Prevention, Awareness of Symptoms, and Treatment), is the first Australian fully online self-guided psycho-education program. It aims to reduce fear of hypo through improved prevention and management of hypos. This study will evaluate the effectiveness, cost-effectiveness and acceptability of HypoPAST. We expect that HypoPAST will lead to lower fear of hypo and improvement in other psychosocial and clinical outcomes. We expect that HypoPAST will be acceptable to adults with T1D and cost effective.
Interventions
HypoPAST is an online psycho-educational training program. It includes 8 modules (30 minutes to 1 hour each), covering topics such as timely and appropriate treatment of hypoglycaemia; personal risks for hypoglycaemia; recognising warning signs of hypoglycaemia; drivers of frequent hypoglycaemia; talking about hypoglycaemia with family, friends, health professionals and colleagues; hypoglycaemia while asleep; and managing worries. HypoPAST includes short videos, slides with voiceovers, reflectio
HypoPAST is an online psycho-educational training program. It includes 8 modules (30 minutes to 1 hour each), covering topics such as timely and appropriate treatment of hypoglycaemia; personal risks for hypoglycaemia; recognising warning signs of hypoglycaemia; drivers of frequent hypoglycaemia; talking about hypoglycaemia with family, friends, health professionals and colleagues; hypoglycaemia while asleep; and managing worries. HypoPAST includes short videos, slides with voiceovers, reflection and problem-solving activities, and information leaflets. HypoPAST is designed to enable participants to discover for themselves how to strengthen their skills and develop preventative habits enabling them to reduce both their fear and their risk of hypoglycaemia. Upon entry to the program, a brief ‘Getting Started’ self-assessment will help participants to recognise which modules are most relevant to their needs. Participants will be advised that completing all modules is recommended, but they will be able to begin with the modules that are most relevant to them, based on their responses to some brief questions. After completing the 'Getting Started' module, participants will be able to view and complete the HypoPAST modules and resources (activity sheets, information leaflets, videos). HypoPAST is self-guided, thus participants can choose whether they complete some or all the modules, all in one sitting or spread out over several days or a few weeks. There is no limit on how often they access the intervention. It is anticipated that 4-8 weeks will be sufficient time for participants to access HypoPAST online, do the activities, and begin to benefit from the program, however they will be able to access the intervention for 24 weeks. Program utilisation will be monitored using website analytics.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible participants will meet all of the following criteria: 1) Adults (18 years or older) 2) Living in Australia 3) Self-reported type 1 diabetes (measured by a study-specific item asking 'What type of diabetes do you have') 4) Self-reported fear of hypoglycaemia (response to a single item from the PAID scale: 'Worrying about low blood glucose reactions' is currently a 'moderate', 'somewhat serious', or 'serious' problem) 5) Access to the internet via a smartphone, laptop or desktop computer, or tablet computer. Ethics approval for this protocol change (change to inclusion criteria 5) was granted by DUHREC on Thursday 13 June 2024. The protocol change was implemented on 14 June 2024, after enrolment of 151 participants (2 of whom withdrew prior to randomisation).
Exclusion criteria
HypoPAST Steering Group member
Outcome results
None listed