Enhanced Physical Activity Support in Congenital Heart Disease Clinical Care

Congenital Heart Disease Clinical Trial

— PAToolKit  

Official title:

Impacting Child Physical and Mental Health Outcomes in Congenital Heart Disease: A Randomized, Controlled Trial of Enhanced Physical Activity Support in Clinical Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03435354
• Other study ID #: 17/191X
• Status: Completed
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: May 31, 2023

Study information

• Verified date: August 2023
• Source: Children's Hospital of Eastern Ontario
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Behavioral:
• Physical activity counselling
Clinician counselling about physical activity using standardized tools to promote daily physical activity.

Locations

Country	Name	City	State
Canada	Stollery Children's Hospital	Edmonton	Alberta
Canada	London Health Sciences Centre	London	Ontario
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario

Sponsors (6)

Lead Sponsor	Collaborator
Children's Hospital of Eastern Ontario	Canadian Congenital Heart Alliance, CHEO Family Forum, London Health Sciences Centre, Ontario Child Health Support Unit, Stollery Children's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinic visit time	Time from arrival to departure of patient for clinic visit	Baseline
Other	Number of PA encounters	Number of times that patients contact the clinic between clinics for reasons related to physical activity	Through study completion on average 6 months
Other	Delivery of PA counselling	Proportion of intervention patients who receive enhanced physical activity counselling during clinic visit	Through study completion, on average 6 months
Other	Advanced PA counselling	Proportion of intervention patients who are referred to kinesiologist for additional support	Through study completion, on average 6 months
Primary	Change in daily physical activity	Pedometer step counts per day	Baseline then first week of each month for 6 months
Secondary	Change in physical activity adequacy and predilection	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
Secondary	Change in quality of life	Pediatric Quality of Life Inventory (PedsQL), score range 0 to 100, higher score is better quality of life	Baseline, 6 months
Secondary	Change in physical literacy	PLAY Tools Run2 and screening question	Baseline, 6 months