Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Healthy Lifestyles for Children With Complex Heart Problems (ReACH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Children's Hospital of Eastern Ontario
Sponsor:
Collaborators:
Variety Village
Heart and Stroke Foundation of Ontario
City of Toronto Parks, Forestry and Recreation
Information provided by (Responsible Party):
Dr. Pat Longmuir, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT01785498
First received: February 4, 2013
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Congenital Heart Defects
Inherited Cardiac Arrhythmias
Cardiomyopathy
Behavioral: Supplementary resources

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Healthy Lifestyles for Children With Complex Heart Problems

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Eastern Ontario:

Primary Outcome Measures:
  • Family perception of clinical service [ Time Frame: Within 2 weeks of clinic visit ] [ Designated as safety issue: No ]
    Likert scales to measure family satisfaction with healthy lifestyle information and resources provided during clinic visit.

  • Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: Within 2 weeks of clinic visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline of Children's Self-Perceived Adequacy and Predilection for Physical Activity [ Time Frame: 1 month after intervention completion ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change from Baseline in Multi-dimension anxiety scale for children [ Time Frame: 1 month after intervention completion ] [ Designated as safety issue: No ]
  • Change from Baseline in Pediatric Symptom Checklist [ Time Frame: 1 month after intervention completion ] [ Designated as safety issue: No ]
  • Change from Baseline in PedsQL Family Impact Module [ Time Frame: 1 month after intervention completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
Receive standard clinical care and supports.
Experimental: Supplementary resources
Receive standard care and supports plus supplementary resources developed for the intervention.
Behavioral: Supplementary resources
Clinical and educational resources for patients, their families and the professionals who care for them.

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01785498

Contacts
Contact: Pat Longmuir, PhD 6137383908 plongmuir@cheo.on.ca

Locations
Canada, Ontario
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Pat Longmuir, PhD    6137383908    plongmuir@cheo.on.ca   
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
Variety Village
Heart and Stroke Foundation of Ontario
City of Toronto Parks, Forestry and Recreation
  More Information

No publications provided

Responsible Party: Dr. Pat Longmuir, Scientist, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT01785498     History of Changes
Other Study ID Numbers: REB12/04X, 2012-06-1-4460033
Study First Received: February 4, 2013
Last Updated: February 5, 2013
Health Authority: Canada: Canadian Institutes for Health Research

Keywords provided by Children's Hospital of Eastern Ontario:
children
quality of life
physical activity
healthy lifestyle

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Cardiomyopathies
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014