Background: The global prevalence of diabetes mellitus (DM) has been increasing over recent decades. In Germany, the prevalence for DM type 1 and type 2 in adults is estimated at about 7.7%. Hence, diabetes has to be classified as a serious public health concern. Being diagnosed with DM and facing possible sequelae might have a negative impact on patients' mental and physical well-being. However, diabetes not only affects patients themselves, but also their close relatives. To improve the quality of life for patients and relatives alike, the German Association of Diabetes Nurses and Education experts (VDBD) elaborated the first education program tailor-made for relatives of diabetes patients. This article describes the concept and design of the trial evaluating the efficacy of this education program called "DiaLife-Living Together with Diabetes".
Methods: This evaluation study is a cluster randomized controlled trial, in which the study centers will be randomly assigned either to the intervention group or the control group. Study centers will recruit relatives of and patients with DM type 1 and type 2. Members of the intervention group will participate in the education program DiaLife, whereas participants randomized in the control group will act as waiting-list controls. The study will assess the efficacy of DiaLife by comparing diabetes-related knowledge between the intervention and control groups as the primary outcome for participants. As the primary outcome in patients, the Hba1c value will be assessed. In addition, diabetes-related distress, family interaction, and other secondary endpoints will be considered as secondary outcomes. Long-term efficacy will be assessed 6 and 12 months after intervention. Hierarchical regression models will be used to analyze effects over time.
Discussion: While there is scientific evidence for the efficacy of education programs addressed to (diabetes) patients, there is a research gap with regard to intervention studies evaluating the efficacy of education programs designed for patients' relatives. The study results will provide information on the efficacy of the DiaLife education program. In addition, factors that might hinder a successful implementation of an education program for relatives will be identified.
Trial registration: German Clinical Trials Register, DRKS00015157 . Registered on 24 August 2018.
Keywords: Cluster randomized controlled trial; Diabetes; Education program; Evaluation study; Relatives; Treatment.