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Table 1 Overview of outcome parameters, co-variables and instruments of the GEDIMAplus trial a

From: Practice network-based care management for patients with type 2 diabetes and multiple comorbidities (GEDIMAplus): study protocol for a randomized controlled trial

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self-care Summary of Diabetes Self-Care Activities Measure–German version (SDSCA-G) PQ [9] (our own translation, unpublished)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]
  1. 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.