Heart Disease Clinical Trial
Official title:
Coping With Physical Activity and Psychosocial Challenges in Children With Heart Disease at Geilomo Childrens Hospital
Background: In Norway each year 130-150 children are born with heart disease that requires
lifelong medical follow-up. Children with heart defects have reduced motor skills and
reduced physical capacity compared with healthy peers. Increased knowledge in the children
themselves and the general public, along with psychosocial interventions improve the child's
ability to cope with the consequences of their disease. Descriptions of the experiences that
Norwegian children with heart disease and their parents have about participation in
rehabilitation programs is limited. Geilomo children's hospital has 75 years experience in
rehabilitation of children with chronic illness, and started in 2005 to welcome children
with heart disease. At present there is no rehabilitation institutions in Norway that has a
special group programs for children with heart disease. Geilomo want to establish such a
group for children aged 6-7 years and 11-12 years.
Main objective: The investigators will use of methods to learn more about the following:
Study 1: The purpose is to generate knowledge about how children with heart disease and
their relatives experience participation in a rehabilitation program at Geilomo children's
hospital.
Overarching question: How do children with heart disease and their guardians to participate
in a rehabilitation program, and the impact of this on their daily life afterwards?
Study 2: The purpose is to help a) to give the children an increased level of activity in
the home environment.
Question: Will children with heart disease increase their activity levels at home after a
stay at Geilomo? 2b) for the children to improve their physical fitness. Question: Will
children with heart disease have improved their physical condition three months after a stay
at Geilomo?
Work schedule: The project will have a duration of 3 years. The project will seek approval
of the Regional Committee for Medical Research Ethics in May 2012. Interview Guide,
information sheet and consent form has been prepared. Data collection for the study 2AB can
start in March 2013. The first interviews will be conducted after 3 months, in June 2013.
Data collection is expected to be completed in December 2013. The analysis will take place
in parallel with the interview work. In 2014 and 2015 completed the writing of articles (3
pieces) and publication of results.
Method: In order to shed light on the problem in study 1, the investigators will use
semi-structured interview. 16 children and 16 parents to be interviewed after 3 months.
Study 2a) To get information about their child's activity level in the home environment the
investigators will use structured questionnaires. It is one form for children (36 persons)
and another form for their parents (36 persons). Study 2b) All children (36 persons)
conducting physical fitness test at the first visit and after three months. Children can be
referred from across the country via the referral form. Dr. Henrik Holm (OUS) and Dr. Asle
Hirth (HUS) determines participation according to inclusion and exclusion criteria.
Parents submit a written consent on behalf of themselves and their children.
Scientific significance: This application describes two related studies, both of which are
expected to provide important information that can provide better services for children with
heart disease.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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