Active With Heart Disease
Coping With Physical Activity and Psychosocial Challenges in Children With Heart Disease at Geilomo Childrens Hospital
1 other identifier
interventional
48
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Mar 2013
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2012
CompletedFirst Posted
Study publicly available on registry
June 21, 2012
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJune 21, 2012
June 1, 2012
1.8 years
June 19, 2012
June 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Increased level of physical activity
3 months
Secondary Outcomes (1)
Increased physical fitness
3 months
Study Arms (2)
Group 2, 6-7 years
EXPERIMENTAL18 children (6-7 years) with heart disease participating in a rehabilitation programme in Geilomo childrens hospital
Group 1, 11-12 years
EXPERIMENTAL18 children(11-12 years) with heart disease participating in a rehabilitation programme at Geilomo childrens hospital.
Interventions
physical activity three weeks
Eligibility Criteria
You may qualify if:
- Children with heart disease in the age groups 6-7 years and 11-12 years with the need for lifelong medical treatment.
You may not qualify if:
- Children with serious mentally retardation and/or significant physical disabilities. Children and caregivers who does not speak norwegian or for other reasons have problems with communication that makes a interview difficult.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Geilomo barnesykehus
Geilo, Buskerud, 3581, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2012
First Posted
June 21, 2012
Study Start
March 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2015
Last Updated
June 21, 2012
Record last verified: 2012-06