Remote Patient Monitoring and Teleconsultation to Improve Health Outcomes and Reduce Health Care Utilization of Pediatric Asthma (ALPACA Study): Protocol for a Randomized Controlled Effectiveness Trial

BACKGROUND: Childhood asthma is imposing a great financial burden on the pediatric health care system. Asthma costs are directly related to the level of asthma control. A substantial part of these costs may be preventable by the timely and adequate assessment of asthma deterioration in daily life and proper asthma management. The use of eHealth technology may assist such timely and targeted medical anticipation. OBJECTIVE: This paper describes the Ambulatory Pediatric Asthma Care (ALPACA) study protocol to investigate the effectiveness of an eHealth intervention consisting of remote patient monitoring and teleconsultation integrated into the daily clinical care of pediatric patients with asthma. This intervention aims to reduce health care utilization and costs and improve health outcomes compared to a control group that receives standard care. In addition, this study aims to improve future eHealth pediatric asthma care by gaining insights from home-monitoring data. METHODS: This study is a prospective randomized controlled effectiveness trial. A total of 40 participants will be randomized to either 3 months of eHealth care (intervention group) or standard care (control group). The eHealth intervention consists of remote patient monitoring (spirometry, pulse oximetry, electronic medication adherence tracking, and asthma control questionnaire) and web-based teleconsultation (video sharing, messages). All participants will have a 3-month follow-up with standard care to evaluate whether the possible effects of eHealth care are longer lasting. During the entire study and follow-up period, all participants will use blinded observational home monitoring (sleep, cough/wheeze sounds, air quality in bedroom) as well. RESULTS: This study was approved by the Medical Research Ethics Committees United. Enrollment began in February 2023, and the results of this study are expected to be submitted for publication in July 2024. CONCLUSIONS: This study will contribute to the existing knowledge on the effectiveness of eHealth interventions that combine remote patient monitoring and teleconsultation for health care utilization, costs, and health outcomes. Furthermore, the observational home-monitoring data can contribute to improved identification of early signs of asthma deterioration in pediatric patients. Researchers and technology developers could use this study to guide and improve eHealth development, while health care professionals, health care institutions, and policy makers may employ our results to make informed decisions to steer toward high-quality, efficient pediatric asthma care. TRIAL REGISTRATION: ClinicalTrials.gov NCT05517096; https://clinicaltrials.gov/ct2/show/NCT05517096 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/45585