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Enhanced Physical Activity Support in Congenital Heart Disease Clinical Care (PAToolKit)

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ClinicalTrials.gov Identifier: NCT03435354
Recruitment Status : Enrolling by invitation
First Posted : February 16, 2018
Last Update Posted : March 9, 2018
Sponsor:
Collaborators:
Stollery Children's Hospital
London Health Sciences Centre
CHEO Family Forum
Canadian Congenital Heart Alliance
Ontario Child Health Support Unit
Information provided by (Responsible Party):
Dr. Pat Longmuir, Children's Hospital of Eastern Ontario

Brief 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).


Condition or disease Intervention/treatment Phase
Congenital Heart Disease Behavioral: Physical activity counselling Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
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)
Masking Description: Those conducting the post-intervention assessments will be blind to study group allocation.
Primary Purpose: Prevention
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
Actual Study Start Date : March 5, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Physical activity counselling during cardiac clinic visit with additional supports for community physical activity and access to a kinesiologist.
Behavioral: Physical activity counselling
Clinician counselling about physical activity using standardized tools to promote daily physical activity.
Other Name: PA counselling

No Intervention: Usual Care
Cardiac clinic visit with usual care but no physical activity counselling



Primary Outcome Measures :
  1. Change in daily physical activity [ Time Frame: Baseline then first week of each month for 6 months ]
    Pedometer step counts per day


Secondary Outcome Measures :
  1. 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).

  2. 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

  3. Change in physical literacy [ Time Frame: Baseline, 6 months ]
    PLAY Tools Run2 and screening question


Other Outcome Measures:
  1. Clinic visit time [ Time Frame: Baseline ]
    Time from arrival to departure of patient for clinic visit

  2. 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

  3. 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

  4. Advanced PA counselling [ Time Frame: Through study completion, on average 6 months ]
    Proportion of intervention patients who are referred to kinesiologist for additional support



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435354


Locations
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Canada, Alberta
Stollery Children's Hospital
Edmonton, Alberta, Canada
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
Stollery Children's Hospital
London Health Sciences Centre
CHEO Family Forum
Canadian Congenital Heart Alliance
Ontario Child Health Support Unit
Investigators
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Principal Investigator: Patricia Longmuir, PhD Scientist

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Responsible Party: Dr. Pat Longmuir, Scientist, Assistant Professor, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT03435354     History of Changes
Other Study ID Numbers: 17/191X
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study is funded by CIHR. Data is required to be shared upon completion of the project.
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Pat Longmuir, Children's Hospital of Eastern Ontario:
Physical activity
Quality of life
Activity motivation
Children
Adolescents
Cluster-randomized trial

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities