Data analyses
REGRESSION, RECRUITMENT
Feasibility outcomes (participant recruitment, data collection procedures, intervention delivery, RCT resources) are calculated as descriptive statistics and assessed relative to criteria established prior to study implementation. Based on our previous intervention trials with children with CHD, it is established that recruitment is considered feasible if at least 60% of families are willing to enroll and less than 20% of patients are ineligible, missed or withdrawn. Inclusion criteria are revised if more than 5% of patients required a cardiologist consult to determine eligibility. Data collection procedures are feasible if at least 80% of participants completed pre-treatment data, including accelerometer wear, and the scores from parents and healthcare professionals indicated that both the time and burden of data collection are acceptable (> 60 mm on visual analogue scale). Less than 20% of participants are to have missing data or data collection sessions during study participation. The intervention is feasible if less than 20% of families withdraw prior to study completion, and at least 70% of families complete the activities at least 3 times per week. The resources to conduct the study are feasible if adequate space is available for 100% of baseline testing sessions and the Research Coordinator has sufficient time to identify, consent, assess and intervene with all children receiving CHD treatment.Frequency tabulations and descriptive statistics (mean±SD or median [q1, q3] as appropriate) are used to describe study participants. Logistic regression, adjusted for age, sex and group (intervention/control) is used for the preliminary assessment of study visit impact (1/2/3/4) on achievement of age-appropriate movement skills (Peabody Total Score < 1 SD from mean) or physical activity (180 mins/day). Groups are compared at each time point (chi-square). To examine group differences on changes in a) physical activity and b) motor skills, repeated measures ANOVA are used. Group (intervention/control) and time (baseline, 6 months, 12 months) are the within-repeated measures factor, with age, sex, and season as covariates. These analyses are not powered to determine statistical effects but will provide descriptive statistics for the feasibility study. Change in physical activity and motor skill effect sizes by study group indicating potential intervention impact, will be used to inform the required sample size for a fully powered multi-site randomized controlled trial and confirmed outcome variable changes are in the expected direction.