1 Division of Nursing, Department of Health Sciences, Lund University, 221 00 Lund, Sweden
2 Department of Paediatrics, Lund University Hospital, SE-221 85 Lund, Sweden
3 The Swedish Institute for Health Sciences, Lund University, Sweden
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.
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.
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.
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 Register NCT00804232.
Keywords: Type 1 diabetes, disease management, family, research design, randomised controlled trial, haemoglobin A1c.
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* Address correspondence to this author at the Division of Nursing, Department of Health Sciences, Lund University, SE-221 00 Lund, Sweden; Tel: +46 46 222 19 21; Fax: +46 46 222 19 34; E-mail: Iren.Tiberg@med.lu.se