The Efficacy of a Home Monitoring App for Children With Medical Complexity: Protocol for a Randomized Controlled Trial

Children with medical complexity (CMC) experience frequent acute health deteriorations, leading to recurrent hospitalizations. Home monitoring has been suggested to help reduce hospitalizations among CMC, yet the benefits have not been demonstrated. MyChildCMC is a novel app, co-designed with parents, that supports CMC home monitoring to identify early warning signs of acute health changes to promote timely intervention.

This study aims to assess the efficacy of the MyChildCMC intervention on child and parent outcomes and the sustainability of MyChildCMC use by parents and of the intervention's effects.

This is a 12-month, 2-arm randomized controlled trial recruiting 360 CMC (aged 1-18 years) and their parents: 180 child-parent dyads assigned to the MyChildCMC app and 180 to the control arm. Participants randomized to the MyChildCMC arm use a sensor and digital thermometer to record vital signs (temperature, heart rate, respiratory rate, and oxygen saturation) and symptoms (pain, feeding/fluid intake, mental status, and seizures) in the app daily and receive immediate feedback. Parents receive alerts for early signs of their child's health deterioration and can view summary reports and individual graphs about the child's health status in the app. Alerts are also sent to the care team, who can view, via a web-based dashboard, summary reports and individual graphs to support timely care. Participants randomized to the control arm use the sensor/thermometer to record the same clinical parameters daily in a diary. Both arms receive financial incentives for daily monitoring and for responding to surveys at baseline and at 3, 6, and 12 months. The efficacy will be assessed at 6 months. The monitoring incentive will be stopped at 6 months, but participants will continue with daily monitoring for 6 more months to assess sustainability at 12 months. The primary outcome is the number of hospital admissions among CMC. Secondary outcomes are assessed for the child (hospital days and quality of life) and the parent (stress, self-efficacy, and satisfaction with the child's care).

We will determine the extent to which the use (vs controls) of the MyChildCMC app leads to reduced emergency department/hospital admissions among CMC. We will also determine whether MyChildCMC use leads to improvements in secondary outcomes. Before the current full-scale study, we conducted a pilot trial, which showed promising results. However, the study was not powered to detect differences in hospital admissions. A larger, definitive study of MyChildCMC's impact was needed to confirm these results. Recruitment for the current study started on January 6, 2026, and will end by March 31, 2028. To date, 41 participants have been enrolled. We expect the last participant to complete the study by March 31, 2029, and thereafter we will analyze the data.

The MyChildCMC app was designed to support CMC home monitoring and proactive care. If efficacious, it will serve as a new model for reducing hospital admissions, with the potential for broad dissemination.