Type 1 diabetes mellitus (T1DM) is the most common metabolic disorder in childhood with an incidence of approximately 1.7 per 1000 children under the age of 20. Studies report that parents are overwhelmed during the early days, after initial diagnosis, due to the complex management needs of young children with T1DM. Adding to this stress is the reduction in the average length of hospital stay from 5 days to 2 days. The proposed study builds on data collected during a focus group and 2 pilot studies that support the use of a theoretically derived (self regulation theory) intervention using a human patient simulator (HPS) as a means to enhance parent teaching and diabetes management during the early days of a child's diagnosis. For example, findings from a recent pilot study support undertaking this full-scale clinical trial with subjects who received the education with HPS having improved knowledge, problem-solving, confidence scores, and lower anxiety, and fear of hypoglycemia scores. The primary aim of this multi-site randomized controlled trial is to evaluate the efficacy of the intervention (HPS-PTE=Human Patient Simulation-Parent Teaching Enhancement) with 128 indexed mothers or fathers of children (5-12 years old) newly diagnosed with T1DM. We hypothesize that parents who are randomized to receive HPS-PTE will have significantly higher diabetes knowledge (cognitive visual schemata), technical skill competence, confidence, and lower worry and stress levels compared to those receiving standard diabetes education. In addition, we will describe parents'learning experiences with and without HPS-PTE enhancement, as well as the diabetes nurse educators'experiences using HPS-PTE. We will also explore the effect of the intervention on physiological factors such as hemoglobin A1C, and health care utilization;and whether parent knowledge and problem-solving competence, confidence, fear and anxiety mediate the effects of the intervention;and if parental education and two-parent vs. single parent caregivers moderate the impact of the intervention on child health and parent management outcomes. This study's contribution includes the testing of a theoretically based intervention to help parents manage young children newly diagnosed with T1DM. There is also potential that findings from this study could be used to develop interventions for children with other chronic conditions and to enhance diabetes education with grandparents, babysitters, and eventually school-aged children and adolescents.
This study has tremendous public health relevance and impact potential for enhancing health care education for families and their children who have chronic medical conditions especially as the incidence of Type 1 diabetes has increased in the past several years. This type of advanced visual technology could be easily transferred to school and other community-based settings such as the camp education environment. It also has potential for improving parent and family management of the illness that could result in fewer missed school and work days. School-aged children and adolescents could also be instructed in self-management with this type of enhanced educational strategy.
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