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)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/2432467
- author
- Tiberg, Irén
LU
; Carlsson, Annelie
LU
and Hallström, Inger
LU
- organization
- publishing date
- 2011
- 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
- pmid:22371819
- ISSN
- 1874-4346
- DOI
- 10.2174/18744346011050100111
- language
- English
- LU publication?
- yes
- additional info
- The information about affiliations in this record was updated in December 2015. The record was previously connected to the following departments: Division of Nursing (Closed 2012) (013065000), Paediatrics (Lund) (013002000)
- 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
- 2016-04-01 13:42:24
- date last changed
- 2022-03-21 20:03:44
@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 = {{https://lup.lub.lu.se/search/files/3541543/2969014.pdf}},
doi = {{10.2174/18744346011050100111}},
volume = {{5}},
year = {{2011}},
}