A network-based care management intervention for patients with type II diabetes and multiple comorbidities (GEDIMAplus)

Not Applicable

Completed

• Conditions: Diabetes mellitus type 2 and mulitple co-occuring chronic conditions.; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN83908315
• Lead Sponsor: Federal Ministry for Education and Research (BMBF) (Germany)

Brief Summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24952740 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31188825 (added 13/06/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-25
• Study Completion: 2015-07-31
• Last Update Posted: 1 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 495

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> 1. Change in SDSCA-G at T2<br> 2. Mean change in each of the five dimension of self-care captured by the SDSCA-G<br> 3. Mean change in physician-reported glycosylated hemoglobin A1 (HbA1c %) at T1/T2<br> 4. The cumulative incidence of physician-reported (severe) symptomatic hypoglycemia at T1/T2<br> 5. Mean change in patient-reported health related quality of life (HRQL) at T1/T2<br> 6. Mean change in patient-reported self-efficacy to cope with chronic conditions<br> 7. Differences in service utilization<br> 8. Costs of health care provision and financial burden of informal care between intervention and control group<br>