Table 1.
Overview of outcome parameters, co-variables and instruments of the GEDIMAplus trial a
| Outcome parameters | Measurement instruments | Data sources | References |
|---|---|---|---|
| |
|
|
|
| |
Primary outcome |
|
|
| Diabetes self-care |
Summary of Diabetes Self-Care Activities Measure–German version (SDSCA-G) |
PQ |
[9] (our own translation, unpublished) |
| |
Secondary outcomes |
|
|
| 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] |
| |
Covariables |
|
|
| Type of diabetes therapy |
Patient chart |
PhysQ |
– |
| Comorbidities |
Patient chart |
PhysQ |
– |
| Medication |
Patient chart |
PhysQ |
|
| 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] |
aAUDIT-C, Alcohol Use Disorders Identification Test; FQ, Family member questionnaire; PACIC-S, 11-item Patient Assessment of Chronic Illness Care short form; PAID Short, Problem Areas in Diabetes scale (short version); PhysQ, physician-reported measure captured by physician questionnaire/chart review; PQ: Patient questionnaire/patient-reported measure; SES6G, Self-Efficacy for Managing Chronic Disease 6-item Scale, German version; WHO-5, 5-item World Health Organization (Five) Well-Being Index.