Screening and assessment for post-acute COVID-19 syndrome (PACS), guidance by personal pilots and support with individual digital trainings within intersectoral care: a study protocol of a randomized controlled trial

Abstract

Background: Because the clinical patterns and symptoms that persist after a COVID-19 infection are diverse, a diagnosis of post-acute COVID-19 syndrome (PACS) is difficult to implement. The current research project therefore aims to evaluate the feasibility and the practicability of a comprehensive, interdisciplinary, and cross-sectoral treatment program consisting of a low-threshold online screening and holistic assessment for PACS. Furthermore, it aims to evaluate digital interventions and the use of so-called personal guides that may help to facilitate the recovery of PACS.

Methods: This German study consists of a low-threshold online screening for PACS where positively screened participants will be supported throughout by personal pilots. The personal pilots are aimed at empowering patients and helping them to navigate through the study and different treatment options. Patients will then be randomly assigned either to an intervention group (IG) or an active control group (ACG). The IG will receive a comprehensive assessment of physiological and psychological functioning to inform future treatment. The ACG does not receive the assessment but both groups will receive a treatment consisting of an individual digital treatment program (digital intervention platform and an intervention via a chatbot). This digital intervention is based on the needs identified during the assessment for participants in the IG. Compared to that, the ACG will receive a more common digital treatment program aiming to reduce PACS symptoms. Importantly, a third comparison group (CompG) will be recruited that does not receive any treatment. A propensity score matching will take place, ensuring comparability between the participants. Primary endpoints of the study are symptom reduction and return to work. Secondary outcomes comprise, for example, social participation and activities in daily life. Furthermore, the feasibility and applicability of the online screening tool, the holistic assessment, digital trainings, and personal pilots will be evaluated.

Discussion: This is one of the first large-scale studies to improve the diagnosis and the care of patients with PACS by means of empowerment. It is to be evaluated whether the methods utilized can be used for the German and international population. Trial registration ClinicalTrials.gov Identifier: NCT05238415; date of registration: February 14, 2022.

Trial registration: ClinicalTrials.gov NCT05238415 NCT05238415 NCT00523841.

Keywords: Cross-sectoral care; Digital therapy offers; Interdisciplinary diagnostic; Long-COVID; Low-threshold screening; Medical rehabilitation; Post-COVID; Post-acute COVID-19 syndrome; Symptom assessment.