Enhanced Physical Activity Support in Congenital Heart Disease Clinical Care
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

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).
    

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.
    

Intervention name(s): Physical activity counselling
Intervention type(s): Behavioral
Intervention description(s): Clinician counselling about physical activity using standardized tools to promote daily physical activity.
Other intervention name(s): PA counselling
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cluster-randomized trial, with randomization by within each site by week (i.e., site-week)
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Physical activity; Quality of life; Activity motivation; Children; Adolescents; Cluster-randomized trial