Active With Heart Disease

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2012 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01624818
First received: June 19, 2012
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Heart Disease
Behavioral: Cardiac habilitation program
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Coping With Physical Activity and Psychosocial Challenges in Children With Heart Disease at Geilomo Childrens Hospital

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Increased level of physical activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increased physical fitness [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 2, 6-7 years
18 children (6-7 years) with heart disease participating in a rehabilitation programme in Geilomo childrens hospital
Behavioral: Cardiac habilitation program
physical activity three weeks
Experimental: Group 1, 11-12 years
18 children(11-12 years) with heart disease participating in a rehabilitation programme at Geilomo childrens hospital.
Behavioral: Cardiac habilitation program
physical activity three weeks

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with heart disease in the age groups 6-7 years and 11-12 years with the need for lifelong medical treatment.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624818

Contacts
Contact: Merete S Engeseth, Master 0047 41566026 msalve@ous-hf.no
Contact: Asle Hirth, Cand. med ahir@helse-bergen.no

Locations
Norway
Geilomo barnesykehus Not yet recruiting
Geilo, Buskerud, Norway, 3581
Contact: Anne- Britt Foss, bachelor i sykepleie    0047 90888982    anfoss@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01624818     History of Changes
Other Study ID Numbers: 268289
Study First Received: June 19, 2012
Last Updated: June 20, 2012
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Oslo University Hospital:
coping
physical activity
psychosocial
children
heart disease
habilitation

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014