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Trial registered on ANZCTR


Registration number
ACTRN12623000894695
Ethics application status
Approved
Date submitted
24/07/2023
Date registered
21/08/2023
Date last updated
21/08/2023
Date data sharing statement initially provided
21/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The HypoPAST study: evaluation of an online program for Hypoglycaemia Prevention, Awareness of Symptoms and Treatment among adults with type 1 diabetes
Scientific title
The Hypoglycaemia Prevention, Awareness of Symptoms, and Treatment (HypoPAST) online psycho-educational program for adults with type 1 diabetes experiencing fear of hypoglycaemia: A 24-week randomised controlled trial
Secondary ID [1] 309749 0
TTRARP2100
Universal Trial Number (UTN)
Trial acronym
HypoPAST (Hypoglycaemia Prevention, Awareness of Symptoms, and Treatment)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 1 diabetes 330150 0
fear of hypoglycaemia 330151 0
Condition category
Condition code
Mental Health 327029 327029 0 0
Anxiety
Metabolic and Endocrine 327030 327030 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
HypoPAST is an online psycho-educational training program. It includes 8 modules (10-20 minutes 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 'Getting Started', participants will be able to view and complete the HypoPAST modules. 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.
Intervention code [1] 326196 0
Behaviour
Intervention code [2] 326197 0
Treatment: Other
Comparator / control treatment
The wait-list control group will be advised to continue with their usual diabetes self-management, clinical care and support during the trial. Usual diabetes self-management and care varies from person to person, as it is tailored to the person's needs and preferences. However, self-management includes monitoring glucose and taking insulin several times a day according to need, and as advised by their health professional. Usual clinical care typically involves attending consultations every 6-12 months (or more frequently if needed) with an endocrinologist (e.g. for review of HbA1c, medications, screening for complications) and may also involve consultations with a diabetes educator and/or other allied health professionals as needed, in accordance with the annual cycle of care: www.ndss.com.au/managing-diabetes/diabetes-related-complications/diabetes-health-checks.
Control group
Active

Outcomes
Primary outcome [1] 334896 0
Fear of hypoglycaemia worry score, measured with the Hypoglycaemia Fear Survey (HFS-II) worry subscale.
Timepoint [1] 334896 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation). The primary timepoint is end-trial (24-weeks post-randomisation).
Secondary outcome [1] 424017 0
Frequency of severe hypoglycaemia, measured with the Hypoglycaemia Awareness Questionnaire (HypoA-Q; item 2).
Timepoint [1] 424017 0
Will be measured at baseline (pre-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [2] 424018 0
Hypoglycaemia confidence score, measured with the Hypoglycaemia Confidence Scale (HCS).
Timepoint [2] 424018 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [3] 424019 0
Fear of hypoglycaemia behaviour (avoidance) score, measured with the Hypoglycaemia Fear Survey II Short Form Avoidance subscale (HFS-SF).
Timepoint [3] 424019 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [4] 424020 0
Hypoglycaemia-specific quality of life score, measured with the Hypoglycaemia Impact Profile (HIP-12).
Timepoint [4] 424020 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [5] 424021 0
Attitudes to hypoglycaemia awareness score, measured with the Attitudes to Awareness of Hypoglycaemia (A2A; items 4-19).
Timepoint [5] 424021 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [6] 424022 0
Diabetes distress score, measured with the Problem Areas in Diabetes Eleven (PAID-11).
Timepoint [6] 424022 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [7] 424023 0
Depressive symptoms, measured with the Patient Health Questionnaire 2-item screener
Timepoint [7] 424023 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [8] 424024 0
Hypoglycaemia-related post-traumatic stress score, measured with the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) adapted for hypoglycaemia.
Timepoint [8] 424024 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [9] 424390 0
Insulin use, measured with two study specific questions about the number of daily insulin doses/boluses and number of daily insulin units taken.
Timepoint [9] 424390 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [10] 424391 0
Hypoglycaemia symptom burden, measured using a study specific question.
Timepoint [10] 424391 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [11] 424536 0
Impaired awareness of hypoglycaemia symptoms using the Hypoglycaemia Awareness Questionnaire Impaired Awareness subscale (HypoA-Q IA; items 7, 8, 10-12).
Timepoint [11] 424536 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [12] 424538 0
Impaired awareness of hypoglycaemia symptoms using the Gold score.
Timepoint [12] 424538 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [13] 424542 0
Technology awareness of hypoglycaemia, measured with 1 study-specific item.
Timepoint [13] 424542 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [14] 424546 0
Most recent HbA1c (self-reported) using two study-specific questions.
Timepoint [14] 424546 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [15] 424547 0
Target glucose range (upper and lower limits, self-reported) measured with two study-specific questions.
Timepoint [15] 424547 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [16] 424549 0
Comfortable glucose level (upper and lower limits, self-reported), measured with two study-specific questions.
Timepoint [16] 424549 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [17] 424550 0
Time below range (self reported, participants wearing a CGM or iCGM device only), measured with a study-specific question.
Timepoint [17] 424550 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [18] 424551 0
Frequency of glucose checks, measured using three study-specific questions.
Timepoint [18] 424551 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [19] 424561 0
Glucose monitoring behaviours (method of recording and use of information), measured using two study-specific questions.
Timepoint [19] 424561 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [20] 424567 0
Hypoglycaemia episodes, measured using uMotif app ‘flower motif’ Ecological Momentary Assessments (10 questions).
Timepoint [20] 424567 0
Measured daily for two weeks at baseline (pre-randomisation) and two weeks end-trial (weeks 24-26 post-randomisation).
Secondary outcome [21] 424568 0
Hypoglycaemia while awake during the day, measured via uMotif app 'check-ins' Ecological Momentary Assessments (6 questions).
Timepoint [21] 424568 0
Measured twice daily for two weeks at baseline (pre-randomisation) and two weeks end-trial (weeks 24-26 post-randomisation).
Secondary outcome [22] 424569 0
Hypoglycaemia while asleep at night, measured via uMotif app 'check-ins' Ecological Momentary Assessments (7 questions).
Timepoint [22] 424569 0
Measured twice daily for two weeks at baseline (pre-randomisation) and two weeks end-trial (weeks 24-26 post-randomisation).
Secondary outcome [23] 424570 0
Sleep quality measured via uMotif app 'check-ins' Ecological Momentary Assessments (1 question)
Timepoint [23] 424570 0
Measured twice daily for two weeks at baseline (pre-randomisation) and two weeks end-trial (weeks 24-26 post-randomisation).
Secondary outcome [24] 424571 0
General well-being measured via uMotif app 'check-ins' Ecological Momentary Assessments (2 questions)
Timepoint [24] 424571 0
Measured for twice daily for two weeks at baseline (pre-randomisation) and two weeks end-trial (weeks 24-26 post-randomisation).
Secondary outcome [25] 424572 0
Fear of hypoglycaemia measured via uMotif app 'check-ins' Ecological Momentary Assessments (2 questions)
Timepoint [25] 424572 0
Measured twice daily for two weeks at baseline (pre-randomisation) and two weeks end-trial (weeks 24-26 post-randomisation).
Secondary outcome [26] 424573 0
Fear of hyperglycaemia measured via uMotif app 'check-ins' Ecological Momentary Assessments (2 questions)
Timepoint [26] 424573 0
Measured twice daily for two weeks at baseline (pre-randomisation) and two weeks end-trial (weeks 24-26 post-randomisation).
Secondary outcome [27] 424574 0
Work productivity measured via uMotif app 'check-ins' Ecological Momentary Assessments (4 questions)
Timepoint [27] 424574 0
Measured twice daily for two weeks at baseline (pre-randomisation) and two weeks end-trial (weeks 24-26 post-randomisation).
Secondary outcome [28] 424575 0
Health status, measured with the Assessment of Quality of Life (AQOL-4D) (for economic evaluation).
Timepoint [28] 424575 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [29] 424576 0
Healthcare utilisation, measured with study-specific items (for economic evaluation). .
Timepoint [29] 424576 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [30] 424577 0
Hypo Cues, measured with the Hypo Cues Questionnaire (Hypo C-Q; Items 2 to 40). The Hypo Cues Questionnaires focuses on potential attributions (e.g. attitudes, beliefs, behaviours) for hypoglycaemia . Cues are attributions or clues as to why a person may experience low glucose.
Timepoint [30] 424577 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [31] 424578 0
Therapeutic alliance, measured with the Mobile Agnew Relationship Measure (M-ARM) (intervention group only).
Timepoint [31] 424578 0
Will be measured at mid-trial (12-weeks post-randomisation).
Secondary outcome [32] 424579 0
Intervention acceptability, measured with study-specific questions (intervention group only).
Timepoint [32] 424579 0
Will be measured at mid-trial (12-weeks post-randomisation).
Secondary outcome [33] 424585 0
User engagement (intervention group only), including login patterns (e.g. whether the intervention was accessed via the webpage or the email reminders), devices used to access the intervention, time spent (minutes) on the intervention and its components, frequency of accessing the intervention and its components. Measured by website analytics (Google Analytics and ADUCI).
Timepoint [33] 424585 0
Will be measured throughout 24-week intervention access period (i.e. post-randomisation to end-trial).
Secondary outcome [34] 425165 0
Anxiety symptoms, measured with the Generalised Anxiety Disorder 2-item screener
Timepoint [34] 425165 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [35] 425166 0
Fear of hypoglycaemia behaviour (maintain high) scores, measured with the Hypoglycaemia Fear Survey II Short Form Maintain High subscale (HFS-SF).
Timepoint [35] 425166 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [36] 425167 0
Response to hypoglycaemia, measured with a study-specific item.
Timepoint [36] 425167 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [37] 425191 0
Work productivity, measured with study-specific items (for economic evaluation).
Timepoint [37] 425191 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).
Secondary outcome [38] 425768 0
Time above range (self reported, participants wearing a CGM or iCGM device only), measured with a study-specific question.
Timepoint [38] 425768 0
Will be measured at baseline (pre-randomisation), mid-trial (12-weeks post-randomisation) and end-trial (24-weeks post-randomisation).

Eligibility
Key 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 one of the following: a) smartphone and laptop/desktop computer, b) smartphone and tablet computer c) tablet computer and laptop/desktop computer
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
HypoPAST Steering Group member

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participant registration, eligibility screening, randomisation, and email notification of group allocations to participants will all be automated and performed centrally by a computer using an eResearch platform (Platform O).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated at random to the intervention or waitlist control arm (1:1). Randomisation sequence will be computer-generated (via Qualtrics/Platform O) arm using randomly permuted block sizes of four and six.

Randomisation will be stratified by: 1) gender: men versus women. If participants have a ‘non-binary’ or ‘another term’ gender identity, they will be allocated at random to either the male or female gender strata. 2) Glucose monitoring method: finger-prick versus CGM or intermittent-scanned CGM (isCGM, also known as ‘flash’ monitoring).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Objective and Methods.
This two-arm, parallel-group, hybrid type 1, mixed-method randomised controlled trial (RCT) has four objectives: 1) to assess the effect of HypoPAST on fear of hypoglycaemia among adults with type 1 diabetes; 2) to assess the effect of HypoPAST on several secondary psychological, clinical and behavioural outcomes (see Secondary Outcomes); 3) to assess the cost-effectiveness of HypoPAST, with an incremental cost-effectiveness ratio below the commonly used threshold of $50,000/quality-adjusted life year; and 4) to undertake a qualitative sub-study to illuminate the RCT findings, explore the acceptability of HypoPAST to adults with type 1 diabetes and understand the extent to which learnings from the program are implementable in the ‘real-world’.
Participants will primarily be recruited via emails to National Diabetes Services Scheme (NDSS) registrants. Survey data will be collected at baseline, mid-trial (week 12-14) and end-trial (week 24-26) via Qualtrics surveys. Ecological momentary assessment (EMA) data collected will be collected twice daily for two weeks at baseline and end-trial via the uMotif app. Telephone interviews (~30-45 mins) will be conducted by experienced researchers (research fellow or research assistant) with approximately 25 intervention group participants at end-trial data. Website analytics will be collected during implementation (week 0-23) to measure program use.

Analysis.
1. Clinical, psychological and behavioural survey outcomes
Statistical analyses will be conducted in STATA MP version 17 (StataCorp). Intention to treat (ITT) approach. Linear mixed models using restricted maximum likelihood estimation will be used to estimate group differences in the primary (HFS-II Worry scale score) and secondary clinical, psychological and behavioural outcomes. Given the primary and secondary outcomes will be measured longitudinally at baseline, 12 and 24 weeks, data at each of these timepoints will be included in the model as the dependent variable. Trial arm (intervention or control) and timepoint (baseline, 12 and 24 weeks) will be included as fixed effects in the models. An interaction term between trial arm and timepoint will be included in the models to estimate group differences at 12 and 24 weeks. Estimated baseline means will be constrained to be equal. Repeated outcome measures will be treated as random effects in the model and an unstructured variance-covariance structure assumed. Models will be adjusted by stratification factors gender and glucose monitoring method. Transformations for skewed outcome measures will be considered. The estimated mean HFS-II Worry scale score at baseline, 12 and 24 weeks will be plotted for each trial arm with 95% confidence intervals. The estimated difference in mean HFS-II Worry score between arms at 12 and 24 weeks and associated 95% confidence intervals will be presented.
A similar modelling approach will be used to estimate group differences in hypoglycaemic events, however, a negative binomial mixed model will be used to account for repeated count data. In secondary analyses, the primary outcome will be adjusted by age, diabetes duration, HbA1c, severe hypoglycaemia episodes in the past 6 months, Gold score and insulin administration modality. Secondary outcomes will also be adjusted by these potential confounders where relevant. A per protocol analysis for the primary outcome will be conducted to estimate the treatment effect in those who engage with the intervention (defined as using 2 or more modules). A sensitivity analysis using multiple imputation may be conducted should there be between 10%-40% missing data in the primary outcome and auxiliary variables available in the data set to explain the missingness. A second sensitivity analysis will be performed on the primary analysis to test the robustness of the missing data assumption of mixed-linear models using pattern-mixture modelling.
2) Health economic survey outcomes
Detailed costing of HypoPAST intervention will be performed using financial data and micro-costing methods. The AQoL-4D utility values for each participant at each timepoint will be used to calculate QALYs using the area under the curve method. The within-trial economic evaluation will measure and value any change in healthcare resource use and then compare any additional costs to additional QALYs through an incremental cost-effectiveness ratio (ICER). Bootstrapping will be used to determine confidence intervals for the ICER and construct an acceptability curve to determine the cost-effectiveness of the intervention against the commonly used willingness to pay threshold of AU$50,000/QALY. Sensitivity analyses will be undertaken to evaluate the robustness of results with changes to costing or analytical assumptions. Scale-up and implementation costs as well as longer-term cost-effectiveness will be estimated based on population-wide modelling techniques based on published epidemiological data. STATA will be used for these analyses.
3) Ecological Momentary Assessment outcomes
To examine the effect of the intervention on EMA outcomes (collected via the uMotif app), we will use multi-level linear regression analysis, with participant ID as random effect. This allows for the intercept of the unique associations (i.e., the overall effect for each participant) to be adjusted for in the model. Several models will be analyzed, including: 1) an unconditional (null) model without predictor variables to obtain the intraclass correlation coefficient (ICC); 2) an unadjusted model without control variables; and 3) an adjusted model including a consensus-guided list of covariates comprising baseline demographic, clinical and psychological factors. All models will be analysed using the Lme4 package in R, with data represented in long-format (one row per repeated entry), and p-values will be obtained using the lmerTest package. Due to the question phrasing and timing of the check-ins, people who expect to primarily sleep during the day during the 2-week EMA data collection will have their EMA data excluded from analysis as it will confound the results.
4) Reach, acceptability, and sustainability (survey and website analytics)
Quantitative data: Will be analysed using descriptive statistics in STATA or R. To determine socioeconomic status and geographical location (indicators of 'reach'), code will be generated to match postcodes against Australian Bureau of Statistics (ABS) Australian Statistical Geography Standards (ASGS) and Index of Relative Socio-economic Advantage and Disadvantage (IRSAD) Socio-Economic Indexes for Areas (SEIFA) quintiles.
Qualitative data: Open-text survey responses will be collated and summarised descriptively in Microsoft Excel. Interview transcripts will be coded using NVivo and/or Microsoft Excel and analysed using thematic analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
196
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313939 0
Government body
Name [1] 313939 0
Australian Government Department of Health and Aged Care, Medical Research Future Fund (MRFF) Targeted Translation Research Accelerator (TTRA)
Country [1] 313939 0
Australia
Funding source category [2] 314323 0
Charities/Societies/Foundations
Name [2] 314323 0
Diabetes Australia
Country [2] 314323 0
Australia
Funding source category [3] 314324 0
Charities/Societies/Foundations
Name [3] 314324 0
Diabetes Victoria
Country [3] 314324 0
Australia
Funding source category [4] 314325 0
Charities/Societies/Foundations
Name [4] 314325 0
Australian Diabetes Society
Country [4] 314325 0
Australia
Funding source category [5] 314326 0
Charities/Societies/Foundations
Name [5] 314326 0
Australian Diabetes Educators Association
Country [5] 314326 0
Australia
Funding source category [6] 314327 0
University
Name [6] 314327 0
Deakin University
Country [6] 314327 0
Australia
Funding source category [7] 314328 0
University
Name [7] 314328 0
La Trobe University
Country [7] 314328 0
Australia
Funding source category [8] 314329 0
University
Name [8] 314329 0
Monash University
Country [8] 314329 0
Australia
Funding source category [9] 314330 0
University
Name [9] 314330 0
University of Melbourne
Country [9] 314330 0
Australia
Funding source category [10] 314331 0
University
Name [10] 314331 0
Newcastle University
Country [10] 314331 0
United Kingdom
Primary sponsor type
University
Name
Deakin University
Address
75 Pigdons Rd, Waurn Ponds VIC 3216
Country
Australia
Secondary sponsor category [1] 316243 0
None
Name [1] 316243 0
Address [1] 316243 0
Country [1] 316243 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313081 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 313081 0
75 Pigdons Rd, Waurn Ponds VIC 3216
Ethics committee country [1] 313081 0
Australia
Date submitted for ethics approval [1] 313081 0
21/04/2023
Approval date [1] 313081 0
27/06/2023
Ethics approval number [1] 313081 0
2023-132

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126930 0
Prof Jane Speight
Address 126930 0
The Australian Centre for Behavioural Research in Diabetes
Diabetes Victoria
Woi-wurrung Country
Suite G01
15-31 Pelham Street
Carlton VIC 3053
Country 126930 0
Australia
Phone 126930 0
+61 3 5227 8415
Fax 126930 0
Email 126930 0
[email protected]
Contact person for public queries
Name 126931 0
Jennifer Halliday
Address 126931 0
The Australian Centre for Behavioural Research in Diabetes
Diabetes Victoria
Woi-wurrung Country
Suite G01
15-31 Pelham Street
Carlton VIC 3053
Country 126931 0
Australia
Phone 126931 0
+61 3 9244 5278
Fax 126931 0
Email 126931 0
[email protected]
Contact person for scientific queries
Name 126932 0
Jane Speight
Address 126932 0
The Australian Centre for Behavioural Research in Diabetes
Diabetes Victoria
Woi-wurrung Country
Suite G01
15-31 Pelham Street
Carlton VIC 3053
Country 126932 0
Australia
Phone 126932 0
+61 3 522 78415
Fax 126932 0
Email 126932 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Metadata of quantitative data will be placed in an open-access repository (Deakin Research Data Store (RDS) with a link to Deakin Research Online (DRO record) and with conditional access to the de-identified data variables available to other researchers upon reasonable request. Data of participants who don't agree for their data to be shared will be removed before data are made open-access/shared.
When will data be available (start and end dates)?
Metadata will be made available after publication of the research findings. Data will be retained for at least fifteen (15) years after the study findings are published.
Available to whom?
Only researchers who provide a methodologically and ethically sound proposal and who sign a Data Sharing Agreement that documents their rationale, how they intend to use the data, and how it will be transferred, stored, and disposed of.
Available for what types of analyses?
The data will be made available only to achieve the aims in the approved proposal and as per the Data Sharing Agreement.
How or where can data be obtained?
Metadata of quantitative data will be open-access via Deakin Research Data Store. Conditional access to the de-identified dataset is available upon reasonable request (to be made to the HypoPAST Project Manager via email: [email protected]). Data will only be shared with researchers willing to sign a Data Sharing Agreement.


What supporting documents are/will be available?

No Supporting Document Provided



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