Healthy Lifestyles for Children With Complex Heart Problems

Cardiomyopathy Clinical Trial

— ReACH  

Official title:

Healthy Lifestyles for Children With Complex Heart Problems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01785498
• Other study ID #: REB12/04X
• Secondary ID: 2012-06-1-446003
• Status: Completed
• Phase: N/A
• First received: February 4, 2013
• Last updated: February 10, 2015
• Start date: January 2012
• Est. completion date: October 2013

Study information

• Verified date: February 2015
• Source: Children's Hospital of Eastern Ontario
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes for Health Research
• Study type: Interventional

Clinical Trial Summary

Healthy Lifestyles for Children with Complex Heart Problems is a planning and resource development project. The goal of the project is to develop an implementation plan that would enable children with complex heart problems to lead healthy, active lives within their own community. The primary goal of the project is to promote physical activity, because the physical and mental health benefits of activity are very important for these children. Children with complex heart problems have a higher risk for obesity, diabetes, acquired heart disease and mental health problems than their healthy peers. The physical health benefits of physical activity are well known, but physical activity is also key for children's mental health. Physical activity enables children to socialize with peers and create bonds and friendships. Physical activity participation also directly elevates mood through the release of brain chemicals. Children with complex heart problems are also known to experience fear and anxiety related to physical activity. This project will also develop strategies to promote healthy eating and the prevention of physical activity-related injuries to these children and their families. Children with complex heart problems are at higher risk of overweight and obesity and face unique injury risks related to pacemakers or their medications.

Extensive consultations with families and caregivers have identified needed supports for physical activity lifestyles, mental health, healthy eating and injury prevention for these children. The goal of the interviews was to understand the positive and negative influences on physical activity and healthy lifestyles for these children. Analyses of the interview content was used to develop a detailed, step-by-step implementation plan to provide the supports necessary for children with complex heart problems to lead active, healthy lives in their own community, with their family and friends. The implementation plan specifies changes to family education and counselling resources, clinical care routines, and communication among professionals and families.

The clinical trial will evaluate the impact of implementing the family supports and changes to practice previously developed. Surveys will be completed by families attending the cardiac clinic before and after the changes to practice and additional resources are made available. Interviews will be utilized to gather additional feedback from professionals and families that receive counselling utilizing the supplementary materials.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 17 Years

Eligibility

Inclusion Criteria:

• child with a heart condition requiring on-going follow up between 4 and 17 years of age or parent or healthcare provider of such a child

• able to verbally answer questions and express opinions in English or French

• able to provide informed consent or assent to participate

Exclusion Criteria:

• disability other than heart condition which significantly impacts physical activity participation or healthy lifestyle habits

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiomyopathies
• Cardiomyopathy
• Congenital Heart Defects
• Heart Defects, Congenital
• Inherited Cardiac Arrhythmias

Intervention

Behavioral:
• Supplementary resources
Clinical and educational resources for patients, their families and the professionals who care for them.

Locations

Country	Name	City	State
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Children's Hospital of Eastern Ontario	City of Toronto Parks, Forestry and Recreation, Heart and Stroke Foundation of Ontario, Variety Village

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Baseline in Multi-dimension anxiety scale for children		1 month after intervention completion	No
Other	Change from Baseline in Pediatric Symptom Checklist		1 month after intervention completion	No
Other	Change from Baseline in PedsQL Family Impact Module		1 month after intervention completion	No
Primary	Family perception of clinical service	Likert scales to measure family satisfaction with healthy lifestyle information and resources provided during clinic visit.	Within 2 weeks of clinic visit	No
Primary	Pediatric Quality of Life Inventory (PedsQL)		Within 2 weeks of clinic visit	No
Secondary	Change from Baseline of Children's Self-Perceived Adequacy and Predilection for Physical Activity		1 month after intervention completion	No