Diabetes mellitus type 2 and mulitple co-occuring chronic conditions. Nutritional, Metabolic, Endocrine
Conditions
Interventions
Participants are randomized to two groups:
1. Intervention:
The 18-month care management intervention (GEDIMAplus) is delivered by a trained health care assistant as ad
Sponsors
Federal Ministry for Education and Research (BMBF) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Primary care practices (PCPs): PCP physicians must fulfill the following criteria: Specialized in General Practice, Internal Medicine or Practical Physician (praktischer Arzt) and function as ?Primary care physician? (Hausarzt) according to German regulations. Both single and group practices (Gemeinschaftspraxen) are eligible to participate. Patients: To be eligible for participation in the study, patients have to be: 1. Aged 18 years or above 2. Diagnosed with type 2 diabetes mellitus (ICD 10: E11-E14) 3. Enrolled in the DMP Diabetes, and diagnosed with at least two severe chronic comorbidities (?schwerwiegende chronische Erkrankung?) according to the definition enshrined in § 62 SGB V. Additionally, written informed consent is a prerequisite for participation in the study. Patient?s caregiving family member: A caregiving family member is defined as the family member who (from the patients? perspective) spends the largest amount of time with informal care (e.g. spouse, partner, father, mother, son, daughter, others) and lives in the same household.
Exclusion criteria
Exclusion criteria: PCPs and patients? caregiving family members: PCPs and patients? caregiving family members who do not fulfill the inclusion criteria will be excluded. Patients: 1. Patients who do not fulfill the inclusion criteria will be excluded. Additional exclusion criteria are patients with: Severe acute psychiatric disorders, e.g. schizophrenia, schizotypal and delusional disorders (ICD 10: F20-F29), dementia (ICD 10: F00-F03), mental and behavioral disorders due to psychoactive substance use (ICD 10: F11-F16; F18; F19) (except for alcohol (ICD 10: F10) and tobacco use (ICD 10: F17)), malignant neoplasms (ICD 10: C00-C97) and/or current chemotherapy or radiotherapy, transplanted organ and tissue status (ICD 10: Z94), care involving dialysis (ICD 10: Z49), insurmountable language and communication problems, emergency cases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in diabetes related selfcare behavior using a German version of the revised ?Summary of diabetes self-care activities measure? (SDSCA-G) after 9 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in SDSCA-G at T2 2. Mean change in each of the five dimension of self-care captured by the SDSCA-G 3. Mean change in physician-reported glycosylated hemoglobin A1 (HbA1c %) at T1/T2 4. The cumulative incidence of physician-reported (severe) symptomatic hypoglycemia at T1/T2 5. Mean change in patient-reported health related quality of life (HRQL) at T1/T2 6. Mean change in patient-reported self-efficacy to cope with chronic conditions 7. Differences in service utilization 8. Costs of health care provision and financial burden of informal care between intervention and control group | — |
Countries
Germany
Outcome results
None listed