A multi-center, individual-level randomized, 18-month, parallel-group superiority trial to compare the efficacy of a complex primary care practice network-based care management intervention versus usual care in the improvement of self-care behavior among patients with type II diabetes and multiple comorbidities (GEDIMAplus)

Federal Ministry for Education and Research (BMBF) (Germany)0 个研究点目标入组 495 人开始时间: 2014年2月25日最近更新: 2019年7月1日

适应症

试验速览

•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.
•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.

•PCPs and patients? caregiving family members:
•PCPs and patients? caregiving family members who do not fulfill the inclusion criteria will be excluded.
•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.

发起方

Federal Ministry for Education and Research (BMBF) (Germany)