- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03435354
Enhanced Physical Activity Support in Congenital Heart Disease Clinical Care (PAToolKit)
Impacting Child Physical and Mental Health Outcomes in Congenital Heart Disease: A Randomized, Controlled Trial of Enhanced Physical Activity Support in Clinical Care
Our cluster randomized controlled trial of a novel clinical practice change will IMPACT the physical activity (PA) of children living with congenital heart defects (CHD) through our
Innovative and pragmatic approach to systematically incorporate PA counselling within each clinic visit. Long-term, the focus is to prevent or treat the most common secondary morbidities of these patients (atherosclerosis, anxiety, depression) through enhanced PA. We have previously shown that home-based, PA interventions can increase daily PA and enhance PA motivation, motor skill and fitness when delivered via an intensive research intervention. Our objectives for this study are to
Measure the feasibility and efficacy of PA counselling using clinical resources among paediatric CHD patients (daily PA, PA motivation, competence, quality of life) and on clinic systems (% patients counselled, clinic/kinesiology personnel support required, clinic visit time, # of PA questions). Our
Patient-empowering, ready-to-use, self-explanatory "tool kit" of clinician PA resources and patient/family/clinician friendly searchable electronic PA database will be used to promote the
Active lifestyles that are critically important to physical/mental health, peer socialization & childhood growth/development. 90% of children are not active enough for optimal health.
We initially target children with CHD because they are less active than peers, and their most important secondary morbidities can be prevented or treated through PA. Our
Collaborative approach with patients, their families and leaders in paediatric cardiac healthcare will optimize our "PA tool kit" and novel practice change for
Translation to all paediatric CHD healthcare systems (primary, secondary, tertiary) through our pan-Canadian Cardiac Kids Quality of LIFFE Research and Knowledge Exchange Network, a collaborative of 10 patient/family support networks and 10 paediatric cardiac clinics in 6 provinces focused on Learning, Independence, Friends, Fitness & Emotional health (LIFFE).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Inactive lifestyles have a huge cost to Canadians' health, our economy and healthcare system (3.7% of total healthcare costs, 2009=$6.8B19). If 10% of Canadians were more active, 25-yr healthcare costs would drop by $2.6B, $7.5B would be added to our economy, & 550,000 fewer Canadians would live with chronic disease. Congenital heart disease (CHD) is the most common congenital condition (12/1000 births) and a major health burden. 90% of CHD children live 4 to 8 decades with a 3-5X higher risk for atherosclerosis, anxiety or depression. Physical activity is known to decrease these important health risks. <10% of Canadian children are active enough for optimal health and, regardless of severity, CHD children are even less active. Individualized kinesiology support can improve physical activity (PA) skill, confidence and participation among CHD children but exceeds current clinical care resources. In response, our team of patients, parents, and clinicians developed a "tool kit" of 12 child/family-friendly PA resources to enable clinicians to better address the most important PA issues for these patients. Our randomized, controlled trial will evaluate a clinical practice change (systematic PA counselling with the PA tool kit plus PA in CHD database) on patient PA and health system outcomes in small (London), medium (Ottawa) and large (Edmonton) paediatric cardiac clinics. Randomization will be by week within each study site to prevent potential intervention cross contamination between children in clinic at the same time. Primary outcome is daily pedometer steps over 1 week. Secondary outcomes are quality of life (PedsQL), physical literacy (CAPL screen) and PA motivation (CSAPPA). Health system outcomes will be: % patients receiving intervention, clinic visit time, # of non-clinic contacts about PA, and need for kinesiology referral. Patient outcomes will be assessed during the CHD clinic visit and at 6 months, with pedometer steps also measured each month. We will enroll consecutive CHD patients with moderate or severe CHD, 5 - 17 yrs, & no other diagnosis affecting PA. Based on our data from previous PA studies among CHD patients and anticipating 10 patients/month, we would require 15 months of data collection (10% dropout) to obtain the 136 complete data sets required to provide 80% power to detect a clinically meaningful increase in daily PA of 1000 steps/day. Repeated measures ANOVA will evaluate study group impact (control/intervention) on pedometer steps. Secondary ANCOVA models will adjust for age, sex, treatment history and clinic site (Ottawa, London, Edmonton).
Our research team combines expertise in clinical intervention trials (Longmuir) and study design and analyses (Willan) with patient (Graham) & family (Rouble) experience plus > 60 years of clinical expertise (Lougheed, Norozi, Mackie). All investigators have previous experience leading multi-site research projects and supervising graduate students. Graham (Can. Congenital Heart Alliance) will ensure intervention relevance and scalability to all Canadian CHD patients. CHEO Family Forum (Rouble) will provide parent input. Through this study, we will advance knowledge of healthy, active lifestyles & PA support for CHD patients & the health system impacts of current practice recommendations to promote PA to CHD patients at every clinical encounter.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada
- Stollery Children's Hospital
-
-
Ontario
-
London, Ontario, Canada
- London Health Sciences Centre
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Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All patients 5 to 17 years with CHD diagnoses classified as moderate or severe in complexity by the American College of Cardiology / American Heart Association joint guidelines.
Exclusion Criteria:
- Cardiac intervention (catheterization or surgery) in preceding 6 months. Syndrome/diagnosis affecting physical activity (e.g., developmental disability) or the ability to complete the assessment questionnaires.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Physical activity counselling during cardiac clinic visit with additional supports for community physical activity and access to a kinesiologist.
|
Clinician counselling about physical activity using standardized tools to promote daily physical activity.
Other Names:
|
No Intervention: Usual Care
Cardiac clinic visit with usual care but no physical activity counselling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in daily physical activity
Time Frame: Baseline then first week of each month for 6 months
|
Pedometer step counts per day
|
Baseline then first week of each month for 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in physical activity adequacy and predilection
Time Frame: Baseline, 6 months
|
Children's Self-Perceived Adequacy and Predilection for Physical Activity Scale (total score, range 20 to 80 points, higher values are a better outcome).
|
Baseline, 6 months
|
Change in quality of life
Time Frame: Baseline, 6 months
|
Pediatric Quality of Life Inventory (PedsQL), score range 0 to 100, higher score is better quality of life
|
Baseline, 6 months
|
Change in physical literacy
Time Frame: Baseline, 6 months
|
PLAY Tools Run2 and screening question
|
Baseline, 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinic visit time
Time Frame: Baseline
|
Time from arrival to departure of patient for clinic visit
|
Baseline
|
Number of PA encounters
Time Frame: Through study completion on average 6 months
|
Number of times that patients contact the clinic between clinics for reasons related to physical activity
|
Through study completion on average 6 months
|
Delivery of PA counselling
Time Frame: Through study completion, on average 6 months
|
Proportion of intervention patients who receive enhanced physical activity counselling during clinic visit
|
Through study completion, on average 6 months
|
Advanced PA counselling
Time Frame: Through study completion, on average 6 months
|
Proportion of intervention patients who are referred to kinesiologist for additional support
|
Through study completion, on average 6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Patricia Longmuir, PhD, Scientist
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17/191X
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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