Prospective evaluation of health care services for children and adolescents with post-COVID-19 condition in Bavaria, Germany: study protocol (Preprint)

BACKGROUND Some children and adolescents suffer from late effects of a SARS-CoV-2 infection despite frequently mild courses of the disease. Nevertheless, extensive care for Post-COVID in children and young people is not available yet. A comprehensive care network (“PoCo”) for children and adolescents with Post-COVID has been setup as a model project in Bavaria, Germany. OBJECTIVE The aim of this study is to evaluate the health care services provided within these network structures of care for children and adolescents with Post-COVID in a pre-post study design. METHODS It is envisaged to recruit 160 children and adolescents up to 17 years with Post-COVID who are diagnosed and treated in 16 participating outpatient clinics. Health care utilization, treatment satisfaction, PROs (Patient Reported Outcomes) related to health-related quality of life (primary endpoint), fatigue, post-exertional malaise and mental health will be assessed at different time points (at baseline, after four weeks, three months and six months) using routine data, interviews and self-report questionnaires. RESULTS The study is currently in the recruitment process. This will run from April 2022 until December 2022. Interim analyses will be carried out. A full analysis of the data will be conducted after recruitment is complete. The results will be published. CONCLUSIONS The results will contribute to the evaluation of therapeutic services provided for Post-COVID in children and adolescents and avenues for optimizing care may be identified. CLINICALTRIAL