Table 1.
List of outcome and process measures
| Concepts | Questionnaire | Baseline: precourse appt | Course Completion | Postcourse assessments | |||
| 3 months* | 6 months* | 9 months* | 12 months* | ||||
| Demographic/clinical | |||||||
| Glycaemic control (HbA1c) | N/A | ✓ | ✓ | ✓ | |||
| Lipids | N/A | ✓ | ✓ | ||||
| Body mass index (height/weight) | N/A | ✓ | ✓ | ✓ | |||
| Blood pressure | N/A | ✓ | ✓ | ✓ | |||
| Episodes of severe hypoglycaemia | N/A | ✓ | ✓ | ✓ | |||
| Episodes of ketoacidosis | N/A | ✓ | ✓ | ✓ | |||
| Demographics | Individual items | ✓ | ✓ | ✓ | |||
| Hypoglycaemia awareness | Gold score36 and DAFNE hypo awareness measure | ✓ | ✓ | ✓ | |||
| Primary psychological outcomes | |||||||
| Diabetes-specific quality of life | ADDQoL-1527 | ✓ | ✓ | ✓ | |||
| Secondary psychological outcomes | |||||||
| Diabetes distress | Problem Areas In Diabetes (short-form)37 | ✓ | ✓ | ✓ | |||
| Diabetes-specific quality of life | Dawn Impact of Diabetes Profile38 | ✓ | ✓ | ✓ | |||
| Diabetes-specific positive well-being | 4-item sub-scale of the Well Being Questionnaire39 | ✓ | ✓ | ✓ | |||
| Fear of hypoglycaemia | Hypoglycaemia Fear Survey-11 (short-form)40 | ✓ | ✓ | ✓ | |||
| Health status | Health and Self-Management in Diabetes41 | ✓ | ✓ | ✓ | |||
| Health status | EQ-5D-5L42 | ✓ | ✓ | ✓ | |||
| Healthcare utilisation | Individual items | ✓ | ✓ | ✓ | |||
| Resource allocation | Individual items | ✓ | |||||
| Process measures | |||||||
| Diabetes management experiences (satisfaction) | Diabetes Management Experiences Questionnaire43 | ✓ | ✓ | ✓ | ✓ | ||
| Self-regulatory skills/behavioural regulation | Self-regulation Questionnaire*44 | ✓ | ✓ | ✓ | ✓ | ||
| Diabetes strengths and resilience | Diabetes Strengths and Resilience Questionnaire45 | ✓ | ✓ | ✓ | ✓ | ||
| Beliefs about capabilities: diabetes self-care | Confidence in Diabetes Scale*46 | ✓ | ✓ | ✓ | ✓ | ||
| Beliefs about capabilities: hypoglycaemia confidence | Hypoglycaemia Confidence Scale47 | ✓ | ✓ | ✓ | ✓ | ||
| Diabetes-specific self-care behaviours | Diabetes Self-Care Behaviours48 | ✓ | ✓ | ✓ | ✓ | ||
| Beliefs about consequences of engaging in DAFNE behaviours and weaving diabetes management into everyday routines | Individual items* | ✓ | ✓ | ✓ | ✓ | ||
| Evaluation of technology (DAFNEplus website in intervention group and bolus calculator in control group) | System usability scale49 | ✓ | ✓ | ✓ | |||
*Description about the development and modifications of these questionnaires and individual items are detailed in online supplemental material 4.
ADDQoL, Audit of Diabetes-Dependent Quality of Life Questionnaire; DAFNE, Dose Adjustment For Normal Eating; EQ-5D-5L, EuroQol-5 Dimension 5 Level; N/A, Not Applicable.