RESUMO
AIMS: To evaluate the long-term effectiveness of the Care & Organize Our Lifestyle (COOL) programme, a self-regulation theory-based mHealth programme, on improving disease knowledge and physical activity in youth with congenital heart disease (CHD). DESIGN: A three-arm parallel-group randomized controlled trial. METHODS: A total 143 participants with simple and moderate CHD aged 15-24 years were recruited from June 2016 to February 2018. The 12-month programme compared two active intervention groups to a standard-care control group (n = 47). Participants in one active intervention group (n = 49) were provided with COOL Passport, a mobile healthcare application. Those in the other group (n = 47) were provided with access to the Health Promotion Cloud system and use of game-based interactive platforms along with COOL Passport. Outcomes were the Leuven Knowledge Questionnaire for Congenital Heart Disease and the International Physical Activity Questionnaire-Taiwan Show-Card Version. RESULTS: After 12 months, 103 participants remained; the overall attrition rate was 28%. No significant differences were observed between the groups in any domain of disease knowledge after 6 months or 1 year. Neither active group exhibited significantly greater physical activity intensity than the standard-care control group in any month during the 1 year. CONCLUSION: The mHealth-tailored intervention of the COOL programme did not improve disease knowledge or physical activity in young adults with CHD. IMPACT: The application of the COOL Passport and Health Promotion Cloud system and use of game-based interactive platforms must be modified and verified in future studies and may have clinical potential. TRIAL REGISTRATION: The registry of clinical trials was ClinicalTrials.gov: NCT04264650.