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Healthy Lifestyles for Children With Complex Heart Problems (ReACH)

Primary Purpose

Congenital Heart Defects, Inherited Cardiac Arrhythmias, Cardiomyopathy

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Supplementary resources
Sponsored by
Children's Hospital of Eastern Ontario
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congenital Heart Defects focused on measuring children, quality of life, physical activity, healthy lifestyle

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Eastern Ontario

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Supplementary resources

Arm Description

Receive standard clinical care and supports.

Receive standard care and supports plus supplementary resources developed for the intervention.

Outcomes

Primary Outcome Measures

Family perception of clinical service
Likert scales to measure family satisfaction with healthy lifestyle information and resources provided during clinic visit.
Pediatric Quality of Life Inventory (PedsQL)

Secondary Outcome Measures

Change from Baseline of Children's Self-Perceived Adequacy and Predilection for Physical Activity

Full Information

First Posted
February 4, 2013
Last Updated
February 10, 2015
Sponsor
Children's Hospital of Eastern Ontario
Collaborators
Variety Village, Heart and Stroke Foundation of Ontario, City of Toronto Parks, Forestry and Recreation
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1. Study Identification

Unique Protocol Identification Number
NCT01785498
Brief Title
Healthy Lifestyles for Children With Complex Heart Problems
Acronym
ReACH
Official Title
Healthy Lifestyles for Children With Complex Heart Problems
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Eastern Ontario
Collaborators
Variety Village, Heart and Stroke Foundation of Ontario, City of Toronto Parks, Forestry and Recreation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Defects, Inherited Cardiac Arrhythmias, Cardiomyopathy
Keywords
children, quality of life, physical activity, healthy lifestyle

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Receive standard clinical care and supports.
Arm Title
Supplementary resources
Arm Type
Experimental
Arm Description
Receive standard care and supports plus supplementary resources developed for the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Supplementary resources
Intervention Description
Clinical and educational resources for patients, their families and the professionals who care for them.
Primary Outcome Measure Information:
Title
Family perception of clinical service
Description
Likert scales to measure family satisfaction with healthy lifestyle information and resources provided during clinic visit.
Time Frame
Within 2 weeks of clinic visit
Title
Pediatric Quality of Life Inventory (PedsQL)
Time Frame
Within 2 weeks of clinic visit
Secondary Outcome Measure Information:
Title
Change from Baseline of Children's Self-Perceived Adequacy and Predilection for Physical Activity
Time Frame
1 month after intervention completion
Other Pre-specified Outcome Measures:
Title
Change from Baseline in Multi-dimension anxiety scale for children
Time Frame
1 month after intervention completion
Title
Change from Baseline in Pediatric Symptom Checklist
Time Frame
1 month after intervention completion
Title
Change from Baseline in PedsQL Family Impact Module
Time Frame
1 month after intervention completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada

12. IPD Sharing Statement

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Healthy Lifestyles for Children With Complex Heart Problems

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