Abstract
Aim and objective:To describe the study design of a randomised controlled trial with the aim of comparing two different regimes for children with newly diagnosed type 1 diabetes; hospital-based care and hospital-based home care.Background:Procedures for hospital admission and sojourn in connection with diagnose vary greatly worldwide and the existing evidence is insufficient to allow for any conclusive determination of whether hospital-based or home-based care is the best alternative for most families. Comparative studies with adequate power and outcome measurements, as well as measurements of cost-effectiveness are needed.Design:The study design was based on the Medical Research Council framework for complex interventions. After two to three days with hospital-based care, children between the ages of 3 and 16 were randomised to receive either continued hospital-based care for a total of 1-2 weeks or hospital-based home care, which refers to specialist care in a home-based setting. The trial started in March 2008 at a University Hospital in Sweden and was closed in September 2011 when a sufficient number of children according to power calculation, were included. The primary outcome was the child’s metabolic control during the following two years. Secondary outcomes were set to evaluate the family and child situation as well as the organisation of care.Discussion:Childhood diabetes requires families and children to learn to perform multiple daily tasks. Even though intervention in health care is complex with several interacting components entailing practical and methodological difficulties, there is nonetheless, a need for randomised controlled trials in order to evaluate and develop better systems for the learning processes of families that can lead to long-term improvement in adherence and outcome.Trial Registration:Trial Register NCT00804232.
Highlights
Type 1 diabetes is one of the most common chronic diseases in children and adolescents
Even though intervention in health care is complex with several interacting components entailing practical and methodological difficulties, there is a need for randomised controlled trials in order to evaluate and develop better systems for the learning processes of families that can lead to long-term improvement in adherence and outcome
At the time of discharge and irrespective of randomisation, the paediatrician completed the Psychosocial Assessment Tool (PAT) [48], an instrument for identifying psychosocial risk factors at diagnosis to predict the subsequent use of psychosocial resources, based on the judgement of the diabetes team
Summary
Type 1 diabetes is one of the most common chronic diseases in children and adolescents. Recommendations of the Swedish national guidelines for paediatric diabetes include hospital-based care at the time of diagnosis and intravenous insulin treatment for the first days even if the child is not acutely ill. There are few recent studies that describe hospital admission procedures for children with newly diagnosed type 1 diabetes. ISPAD’s guidelines state that health professionals should deliver structured education using behavioural learner-centred approaches rather than didactic approaches [23]. Both ISPAD’s and national paediatric guidelines emphasise the importance of individualised support and education by a diabetes specialised team [8, 24,25,26]. Age and siblings and parental gender, age, education, income, family situation.
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