Long-term effectiveness of an mHealth-tailored physical activity intervention in youth with congenital heart disease: A randomized controlled trial.

Abstract

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). A three-arm parallel-group randomized controlled trial. A total 143 participants with simple and moderate CHD aged 15-24years 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. After 12months, 103 participants remained; the overall attrition rate was 28%. No significant differences were observed between the groups in any domain of disease knowledge after 6months or 1year. Neither active group exhibited significantly greater physical activity intensity than the standard-care control group in any month during the 1year. The mHealth-tailored intervention of the COOL programme did not improve disease knowledge or physical activity in young adults with CHD. 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. The registry of clinical trials was ClinicalTrials.gov: NCT04264650.