Table 1.
Schedule of HypoPAST assessments
| Assessment | Measure (number of items) | Timepoint (week) | ||
|---|---|---|---|---|
| 0 | 12 | 24 | ||
| Eligibility criteria | ||||
| Age (≥18 years); Self-reported diagnosis (type 1 diabetes); Country (Australia); ‘Worrying about low glucose reactions’ is at least a moderate problem (PAID item score >2); Internet access via one of the following combinations: (1) a smartphone and tablet, (2) tablet only or (3) desktop or laptop and tablet or smartphone; the HypoPAST Type 1 Diabetes Lived Experience Steering Group membership | Study-specific (5 items) plus 1 item from the Problem Areas in Diabetes (PAID) scale [11, 34] | X | - | - |
| Stratification criteria | ||||
| Gender: men vs women | Study-specific (1 item) | X | - | - |
| Primary glucose monitoring method: finger-prick vs CGM/isCGM | Study-specific (1 item) | X | - | - |
| Demographic and clinical characteristics | ||||
| Age at T1D diagnosis, diabetes complications, diabetes education, country of birth, Aboriginal Torres Strait Islander, language(s) at home, State/Territory, postcode, education, employment, relationship status, living with someone who can assist with a hypoglycaemic event | Study-specific (12 items) | X | - | - |
| Insulin use: administration method | Study-specific (1 item) | X | X | X |
| Glucose monitoring: recording and use of glucose checks | Study-specific (2 items) | X | X | X |
| History of severe hypoglycaemia | Study-specific (2 items) | X | X | X |
| Time of main sleep (e.g. night or day) | Study-specific (1 item) | X | - | X |
| Primary outcome | ||||
| Fear of hypoglycaemia | HFS-II Worry subscale (18 items) [61] | X | X | X |
| Secondary outcomes: clinical, psychological and behavioural | ||||
| Most recent HbA1c; target glucose range, comfortable glucose range, time above/below target range; frequency of glucose checks; number of daily doses/boluses; daily insulin units | Study-specific (13 items) | X | X | X |
| Awareness of hypoglycaemia symptoms | Gold score (1 item) [62] | X | X | X |
| Technological awareness: study specific (1 item) | X | X | X | |
| Hypoglycaemia Awareness Questionnaire (HypoA-Q) Impaired Awareness subscale (Items 7-8, 10-12) (5 items) [63] | X | X | X | |
| Hypoglycaemia symptom burden and response | Study-specific (2 items) | X | X | X |
| Hypoglycaemia frequency & severity: Overall (past week & past 6 months); While awake and while asleep (past 6 months) | HypoA-Q: Items 1-4, 15 and 16) (6 items) [63] | X | - | X |
| Behaviours associated with fear of hypoglycaemia | Hypoglycaemia Fear Survey II Short Form (HFS-SF): Avoidance & Maintain High subscales (5 items) [38] | X | X | X |
| Confidence in managing hypoglycaemia | Hypoglycaemia Confidence Scale (9 items) [64] | X | X | X |
| Hypoglycaemia-specific quality of life | Hypoglycaemia Impact Profile (HIP-12; 12 items) [56] | X | X | X |
| Attitudes to awareness of hypoglycaemia | Attitudes to Awareness of Hypoglycaemia scale (A2A; Items 4-19 only; 16 items) [65] | X | X | X |
| Perceptions and experiences of hypoglycaemia | Hypoglycaemia Cues Questionnaire (Hypo C-Q; Items 2-40 only; 39 items) [24] | X | X | X |
| Hypoglycaemia-specific post-traumatic stress | Primary Care PTSD Screen for DSM-5 adapted for hypoglycaemia (PC-PTSD-5a; 5 items) [66] | X | X | X |
| Diabetes distress | PAID scale (PAID-11; 11 items) [11] | X | X | X |
| Anxiety and depressive symptoms | Patient Health Questionnaire (PHQ-4; 4 items) [67] | X | X | X |
| Ecological momentary assessments | ||||
| Hypoglycaemia episodes and symptoms, fear of hypoglycaemia, fear of hyperglycaemia, sleep quality, mood, anxiety, productivity | HypoMETRICS ‘check-ins’ (24 items) and ‘flower motif’ (10 items) [42, 68] | X | - | X |
| Cost-effectiveness | ||||
| Health-related quality of life | Assessment of Quality of Life (AQOL-4D; 12 items) [41] | X | X | X |
| Health service and resource use, productivity | Study-specific (15 items) | X | X | X |
| Process evaluation | ||||
| Acceptability, usability and sustainability | Study-specific questions (39 items) | - | X | - |
| Therapeutic alliance | Mobile Agnew Relationship Measure (mARM; 25 items) [46] | - | X | - |
| Reach and fidelity | Website analytics e.g. login patterns; devices used to access the programme; frequency of accessing and time spent (minutes) on programme and its components. | Throughout 24-week intervention access period | ||
| Acceptability, usability and sustainability | Semi-structured interview schedule: perceptions of HypoPAST (including usability and sustainability), experiences of making behavioural changes in ‘real life’ attributable to HypoPAST | - | - | X |