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

Patients’ Post-/Long-COVID Symptoms, Vaccination and Functional Status—Findings from a State-Wide Online Screening Study

“…Ideally, prospective data should be used for that. Furthermore, we need more experimental studies in which different interventions help people decide on indicative vaccinations [ 24 ] and recover from symptoms and constraints [ 34 ]. Potential vicious circles and maladaptive processes should be addressed [ 12 ], and corresponding interventions need testing in randomized controlled trials.…”

“…However, reviewing the current evidence, we can conclude that vaccinations are just one strategy to prevent severe infections and the long-term, post-acute sequelae of infection [ 26 ]. Attempts to overcome post-/long-COVID should take more options than vaccinations into account, such as behavioral interventions and medical rehabilitation treatments addressing the coping mechanisms, and appropriate, safe patient behavior is required [ 13 , 24 , 34 ]. This is especially important because limited workability is problematic not only for the individual (because of limited social participation and economic demands) but also for society (because of limited productivity and skills shortage, and costly reintegration demands to be covered by the social welfare system).…”

“…The patients were provided a “personal pilot” for individual contacts, and they were enrolled in a structured study program [ 34 ]. Additionally, they received personal coaching sessions with their personal pilot to learn how to utilize the German healthcare system better and get support to deal with their symptoms in everyday life, return to work, and improve their health and well-being sustainably [ 34 ]. The personal pilots also interviewed the participants regarding their vaccination status.…”

“…Participants remained in the study if they screened positive for post-/long-COVID and met the study criteria (see Figure 1 for the drop-out flow chart). To determine whether participants were eligible to take part in the study, patients were asked to fill out a screening tool with symptoms of post-/long-COVID described in a previous publication [ 34 ]. Within this screening, the criteria to be diagnosed with post-/long-COVID were: (1) having at least three out of 14 common post-/long-COVID symptoms (such as fatigue, brain fog, etc.)…”

“…Symptoms were measured at all timepoints [ 34 ]. Participants were asked to indicate their symptoms.…”