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A Methodological Description of a Randomised Controlled Trial Comparing Hospital-Based Care and Hospital-Based Home Care when a Child is Newly Diagnosed with Type 1 Diabetes.

Tiberg, Irén LU ; Carlsson, Annelie LU and Hallström, Inger LU (2011) In Open Nursing Journal 5. p.111-119
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... (More)
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. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Open Nursing Journal
volume
5
pages
111 - 119
publisher
Bentham Science Publishers
external identifiers
  • pmid:22371819
  • scopus:82855169418
ISSN
1874-4346
DOI
10.2174/18744346011050100111
language
English
LU publication?
yes
id
1607ff65-8099-4f65-ba04-bbe7eb18ca3f (old id 2432467)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/22371819?dopt=Abstract
date added to LUP
2012-04-02 11:26:43
date last changed
2017-01-01 05:49:41
@article{1607ff65-8099-4f65-ba04-bbe7eb18ca3f,
  abstract     = {AIM AND OBJECTIVE:<br/><br>
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.<br/><br>
<br/><br>
BACKGROUND:<br/><br>
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.<br/><br>
<br/><br>
DESIGN:<br/><br>
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.<br/><br>
<br/><br>
DISCUSSION:<br/><br>
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.},
  author       = {Tiberg, Irén and Carlsson, Annelie and Hallström, Inger},
  issn         = {1874-4346},
  language     = {eng},
  pages        = {111--119},
  publisher    = {Bentham Science Publishers},
  series       = {Open Nursing Journal},
  title        = {A Methodological Description of a Randomised Controlled Trial Comparing Hospital-Based Care and Hospital-Based Home Care when a Child is Newly Diagnosed with Type 1 Diabetes.},
  url          = {http://dx.doi.org/10.2174/18744346011050100111},
  volume       = {5},
  year         = {2011},
}