Efficacy of Dia Life , an education program for relatives of adult patients with diabetes – study protocol of a cluster randomized controlled trial

This article describes the concept and design of the trial evaluating the efficacy of this education program called “DiaLife—Living Together with Diabetes”.MethodsThis 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.DiscussionWhile 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...
Source: Trials - Category: Research Source Type: clinical trials