title: Practice network-based care management for patients with type 2 diabetes and multiple comorbidities (GEDIMAplus): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Care management interventions in the German health-care system have been evaluated with promising results, but further research is necessary to explore their full potential in the context of multi-morbidity. Our aim in this trial is to assess the efficacy of a primary care practice network-based care management intervention in improving self-care behaviour among patients with type 2 diabetes mellitus and multiple co-occurring chronic conditions.
  
  
  METHODS
  The study is designed as a prospective, 18-month, multicentre, investigator-blinded, two-arm, open-label, individual-level, randomized parallel-group superiority trial. We will enrol 582 patients with type 2 diabetes mellitus and at least two severe chronic conditions and one informal caregiver per patient. Data will be collected at baseline (T0), at the primary endpoint after 9 months (T1) and at follow-up after 18 months (T2). The primary outcome will be the differences between the intervention and control groups in changes of diabetes-related self-care behaviours from baseline to T1 using a German version of the revised Summary of Diabetes Self-Care Activities (SDSCA-G). The secondary outcomes will be the differences between the intervention and control groups in: changes in scores on the SDSCA-G subscales, glycosylated haemoglobin A level, health-related quality of life, self-efficacy, differences in (severe) symptomatic hypoglycaemia, cost-effectiveness and financial family burden. The intervention will be delivered by trained health-care assistants as an add-on to usual care and will consist of three main elements: (1) three home visits, including structured assessment of medical and social needs; (2) 24 structured telephone monitoring contacts; and (3) self-monitoring of blood glucose levels after T1 in 3-month intervals. The control group will receive usual care. The confirmatory primary analysis will be performed following the intention-to-treat (ITT) principle. The efficacy of the intervention will be quantified using two-level linear regression stratified by type of medical treatment adjusted for baseline values on the SDSCA-G. Secondary analyses will be performed according to the ITT principle. In health economic evaluations, we will estimate the incremental cost-effectiveness ratios.
  
  
  CONCLUSIONS
  We hope that the results of this study will provide insights into the efficacy of practice network-based care management among patients with complex health-care needs.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN 83908315 (ISRCTN assigned 25 February 2014).
authors: Department of General Practice and Health Services Research, University Hospital Heidelberg, Voßstrasse 2, Gebäude 37, Heidelberg 69115, Germany. kayvan.bozorgmehr@med.uni-heidelberg.de.
authors: Kayvan
authors: K
authors: Bozorgmehr
authors: Joachim
authors: J
authors: Szecsenyi
authors: Dominik
authors: D
authors: Ose
authors: Werner
authors: W
authors: Besier
authors: Manfred
authors: M
authors: Mayer
authors: Johannes
authors: J
authors: Krisam
authors: Christian O
authors: CO
authors: Jacke
authors: Hans-Joachim
authors: HJ
authors: Salize
authors: Ralf
authors: R
authors: Brandner
authors: Sandra
authors: S
authors: Schmitt
authors: Marion
authors: M
authors: Kiel
authors: Martina
authors: M
authors: Kamradt
authors: Tobias
authors: T
authors: Freund
mesh_terms: D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D015190:Blood Glucose Self-Monitoring; D019090:Case Management / Q000191:economics; D002985:Clinical Protocols; D015897:Comorbidity; D003362:Cost-Benefit Analysis; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis / Q000191:economics / Q000453:epidemiology / Q000523:psychology / Q000628:therapy*; D005858:Germany; D015438:Health Behavior; D017048:Health Care Costs; D007722:Health Knowledge, Attitudes, Practice; D006792:House Calls; D006801:Humans; D057194:Intention to Treat Analysis; D016014:Linear Models; D020380:Needs Assessment; D010353:Patient Education as Topic; D010361:Patients / Q000523:psychology*; D011320:Primary Health Care / Q000191:economics; D011446:Prospective Studies; D012107:Research Design; D012648:Self Care / Q000191:economics; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D001786:Blood Glucose