Table 1 Overview of outcome parameters, co-variables and instruments of the GEDIMAplus trial a
Outcome parameters | Measurement instruments | Data sources | References |
|---|---|---|---|
| Â | Primary outcome | Â | Â |
Diabetes self-care | Summary of Diabetes Self-Care Activities Measure–German version (SDSCA-G) | PQ | [9] (our own translation, unpublished) |
| Â | Secondary outcomes | Â | Â |
Glycosylated haemoglobin A1c | Patient chart | PhysQ | – |
(Severe) symptomatic hypoglycaemia | Patient chart/self-developed items | PhysQ | – |
Health-related quality of life | EuroQol (EQ-5D) | PQ | [23] |
Chronic disease–related self-efficacy | Self-efficacy scale (SES6G) | PQ | [24] |
Health-care utilization and costs | Client Socio-Demographic and Service Receipt Inventory (CSSRI) | PQ | [25] |
Costs of informal care provided by designated family member | Financial family burden (FFB) questionnaire | FQ | [26] |
| Â | Covariables | Â | Â |
Type of diabetes therapy | Patient chart | PhysQ | – |
Comorbidities | Patient chart | PhysQ | – |
Medication | Patient chart | PhysQ | Â |
Perceived quality of care | PACIC-S | PQ | [27] |
Emotional distress | PAID Short | PQ | [28] |
Depression | WHO-5 | PQ | Psychiatric Research Unit, WHO Collaborating Centre for Mental Health, Frederiksborg General Hospital [29] |
Alcohol consumption | AUDIT-C (German version) | PQ | [30] |
Migration status | Recommended ‘basic set of indicators for mapping migrant status’ in Germany | PQ | [31] |
Sociodemographic data (sex, age, housing, partnerships, education, occupation, equalized household income) | Sociodemographic Standards of the Federal Department of Statistics (partially adapted) | PQ | Federal Office for Statistics [32] |
Subjective social status | One-item standardized measure | PQ | German General Social Survey (ALLBUS) [33] |