Ignite Creation Date:
2024-05-06 @ 12:39 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01624818
Status:
UNKNOWN
Last Update Posted:
2012-06-21
First Post:
2012-06-19
Brief Title:
Active With Heart Disease
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Coping With Physical Activity and Psychosocial Challenges in Children With Heart Disease at Geilomo Childrens Hospital
Status:
UNKNOWN
Status Verified Date:
2012-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 childs 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 childrens 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 childrens 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 childs 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
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 childrens 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 childs 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None