The primary outcomes are: 1) well-being in relation to living with diabetes, which will be measured by Problem Areas in Diabetes scale (PAID), and general well-being measured by the subscale mental health from SF-12v2, and 2) HbA1c- and cholesterol (mmol/l) levels.
Diabetes-related distress was measured using the Problem Areas in Diabetes (PAID) questionnaire (17).
DRD was measured using the Problem Areas in Diabetes scale (PAID) (16), a well-validated 20-item self-report questionnaire.
We have selected two joint primary outcomes: glycated haemoglobin (HbA1c) and diabetes-related distress measured by the Problem Areas in Diabetes (PAID) scale [ 15].
The joint primary outcomes are glycated haemoglobin (HbA1c) and diabetes-related distress, measured by the Problem Areas In Diabetes (PAID) questionnaire.
Diabetes distress is measured using The Problem Areas in Diabetes questionnaire (Swe-PAID-20): This is a 20 items questionnaire translated in to Swedish by Amsberg et al. [ 64].
Anxiety symptoms are evaluated using the Beck Anxiety Inventory (T0, T1, T2, T3, T4, T8) [ 60], diabetes-related distress is measured using the Problem Areas In Diabetes questionnaire (T0, T4, T8) [ 61], quality of life using the EuroQol-5 Dimensions questionnaire (T0, T4, T8) [ 62] and disability using the Sheehan Disability Scale (T0, T4, T8) [ 63].
Cronbach's α at baseline for the WHO-5 across the eight countries ranged from 0.81 (Germany) to 0.89 (U.K .. Diabetes-related distress was measured with the Problem Areas In Diabetes scale (PAID), a widely used instrument with proven validity (13).
Diabetes distress (as measured by the Problem Areas in Diabetes scale) was highest for those who had worsening glycemia and lowest for those who had tight control, but these differences were not statistically significant at baseline (P = 0.11) or 12 weeks (P = 0.09).
To ascertain the concurrent validity of the ITAS, patients were asked to fill in two validated and widely used psychological measures: the Problem Areas In Diabetes (PAID) scale and the World Health Organization Five Item Well-Being Index (WHO-5).
