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

Alina Dahmen, Franziska M Keller, Christina Derksen, Robin Rinn, Petra Becker, Sonia Lippke, Alina Dahmen, Franziska M Keller, Christina Derksen, Robin Rinn, Petra Becker, Sonia Lippke

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.

Conflict of interest statement

PB is shareholder of Dr. Becker Group that aims to transfer scientific knowledge into routine healthcare as well as deliver rehabilitation interventions by Dr. Becker Klinikgruppe. AD, FMK, CD, RR and SS have no potential conflicting interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Symptoms of PACS
Fig. 2
Fig. 2
Framework of a successful recovery process building on the Compensatory Carry Over Action Model (CCAM, on basis of Lippke et al. [30])
Fig. 3
Fig. 3
Flowchart of the study design. IG Intervention Group, ACG Active Control Group
Fig. 4
Fig. 4
ASAP core components to enhance patient-centered care of post-acute COVID-19 syndromes

References

    1. Robert Koch Institut. COVID-19 Fallzahlen in Deutschland und Weltweit. 2022. . Accessed 30 May 2022.
    1. Titze-de-Almeida R, Da Cunha TR, Dos Santos Silva LD, Ferreira CS, Silva CP, Ribeiro AP, et al. Persistent, new-onset symptoms and mental health complaints in Long COVID in a Brazilian cohort of non-hospitalized patients. BMC Infect Dis. 2022;22:133. doi: 10.1186/s12879-022-07065-3.
    1. Nalbandian A, Sehgal K, Gupta A, Madhavan MV, McGroder C, Stevens JS, et al. Post-acute COVID-19 syndrome. Nat Med. 2021;27:601–615. doi: 10.1038/s41591-021-01283-z.
    1. Wang X, Che Q, Ji X, Meng X, Zhang L, Jia R, et al. Correlation between lung infection severity and clinical laboratory indicators in patients with COVID-19: a cross-sectional study based on machine learning. BMC Infect Dis. 2021;21:233. doi: 10.1186/s12879-021-05839-9.
    1. National Institute of Health. NIH Plans Research on “Long COVID”. . Accessed 23 Apr 2022.
    1. Paterson RW, Brown RL, Benjamin L, Nortley R, Wiethoff S, Bharucha T, et al. The emerging spectrum of COVID-19 neurology: clinical, radiological and laboratory findings. Brain. 2020;143:3104–3120. doi: 10.1093/brain/awaa240.
    1. Akhmerov A, Marbán E. COVID-19 and the heart. Circ Res. 2020;126:1443–1455. doi: 10.1161/CIRCRESAHA.120.317055.
    1. Seecheran R, Narayansingh R, Giddings S, Rampaul M, Furlonge K, Abdool K, et al. Atrial arrhythmias in a patient presenting with Coronavirus disease-2019 (COVID-19) infection. J Investig Med High Impact Case Rep. 2020;8:2324709620925571. doi: 10.1177/2324709620925571.
    1. Dahmen A, Roukens R, Lindenberg S, Peters KM. Heterotope Ossifikationen nach SARS-CoV-2-Infektion [Heterotopic ossifications after SARS-CoV-2 infection] Orthop Rheuma. 2021;24:30–32. doi: 10.1007/s15002-021-3269-4.
    1. Cai S, Liu L, Wu X, Pan Y, Yu T, Ou H. Depression, anxiety, psychological symptoms and health-related quality of life in people living with HIV. Patient Prefer Adherence. 2020;14:1533–1540. doi: 10.2147/PPA.S263007.
    1. Mazza MG, de Lorenzo R, Conte C, Poletti S, Vai B, Bollettini I, et al. Anxiety and depression in COVID-19 survivors: role of inflammatory and clinical predictors. Brain Behav Immun. 2020;89:594–600. doi: 10.1016/j.bbi.2020.07.037.
    1. Greenhalgh T, Knight M, A’Court C, Buxton M, Husain L. Management of post-acute covid-19 in primary care. BMJ (Clinical Research Ed) 2020;370:m3026. doi: 10.1136/bmj.m3026.
    1. Brown K, Yahyouche A, Haroon S, Camaradou J, Turner G. Long COVID and self-management. Lancet. 2022;399:355. doi: 10.1016/S0140-6736(21)02798-7.
    1. Robert Koch Institiut. Coronavirus SARS-Co-2: Gesundheitliche Langzeitfolgen [ong term health effects]. 2022. . Accessed 13 Mar 2022.
    1. Raveendran AV, Jayadevan R, Sashidharan S. Long COVID: an overview. Diabetes Metab Syndr. 2021;15:869–875. doi: 10.1016/j.dsx.2021.04.007.
    1. Venkatesan P. NICE guideline on long COVID. Lancet Respir Med. 2021;9:129. doi: 10.1016/S2213-2600(21)00031-X.
    1. Koczulla AR, Ankermann T, Behrends U, Berlit P, Böing S, Brinkmann F, et al. S1-Leitlinie post-COVID/long-COVID. [S1 Guideline Post-COVID/Long-COVID] Pneumologie. 2021;75:869–900. doi: 10.1055/a-1551-9734.
    1. Davis HE, Assaf GS, McCorkell L, Wei H, Low RJ, Re’em Y, et al. Characterizing long COVID in an international cohort: 7 months of symptoms and their impact. EClinicalMedicine. 2021;38:101019. doi: 10.1016/j.eclinm.2021.101019.
    1. Augustin M, Schommers P, Stecher M, Dewald F, Gieselmann L, Gruell H, et al. Post-COVID syndrome in non-hospitalised patients with COVID-19: a longitudinal prospective cohort study. Lancet Reg Health Eur. 2021;6:100122. doi: 10.1016/j.lanepe.2021.100122.
    1. Wolf S. Erdos J. Epidemiologie von Long-Covid: ein vorläufiger Bericht. Deutsche Kurzfassung zum gleichnamigen KCE-Bericht. [Epidemiology of long-covid: a preliminary report.]
    1. Ambulantes Long-COVID-Netzwerk der KVB. Anforderungen an die Ambulante Versorgung. [Requirements for outpatient care.] . Accessed 20 May 2021.
    1. Alwan NA. The road to addressing Long Covid. Science. 2021;373:491–493. doi: 10.1126/science.abg7113.
    1. Dieckhoff M, Gash V. Unemployed and alone? Unemployment and social participation in Europe. Int J Sociol Soc Policy. 2015;35:67–90. 10.1108/IJSSP-01-2014-0002.
    1. Ismael F, Bizario JCS, Battagin T, Zaramella B, Leal FE, Torales J, et al. Post-infection depressive, anxiety and post-traumatic stress symptoms: a prospective cohort study in patients with mild COVID-19. Prog Neuropsychopharmacol Biol Psychiatry. 2021;111:110341. doi: 10.1016/j.pnpbp.2021.110341.
    1. Mukaetova-Ladinska EB, Kronenberg G. Psychological and neuropsychiatric implications of COVID-19. Eur Arch Psychiatry Clin Neurosci. 2021;271:235–248. doi: 10.1007/s00406-020-01210-2.
    1. Malik P, Patel K, Pinto C, Jaiswal R, Tirupathi R, Pillai S, Patel U. Post-acute COVID-19 syndrome (PCS) and health-related quality of life (HRQoL)-a systematic review and meta-analysis. J Med Virol. 2022;94:253–262. doi: 10.1002/jmv.27309.
    1. Chippa V, Aleem A, Anjum F. Post-acute coronavirus (COVID-19) syndrome. . Accessed 5 May 2022.
    1. World Health Organization (WHO). Support for rehabilitation: self-management after COVID-19 related illness. . Accessed 5 May 2022.
    1. Baz S, Fang C, Carpentieri JD, Sheard L. Understanding the lived experience of Long Covid: a rapid literature review; 2021.
    1. Lippke S, Dahmen A, Gao L, Guza E, Nigg CR. To what extent is internet activity predictive of psychological well-being? Psychol Res Behav Manag. 2021;14:207–219. doi: 10.2147/PRBM.S274502.
    1. Long COVID Deutschland. Bundesweite Initiative für die Belange von Long-COVID-Betroffenen. . Accessed 23 Apr 2022.
    1. Arnold DT, Hamilton FW, Milne A, Morley AJ, Viner J, Attwood M, et al. Patient outcomes after hospitalisation with COVID-19 and implications for follow-up: results from a prospective UK cohort. Thorax. 2021;76:399–401. doi: 10.1136/thoraxjnl-2020-216086.
    1. Keller FM, Dahmen A, Derksen C, Kötting L, Lippke S. Psychosomatic rehabilitation patients and the general population during COVID-19: online cross-sectional and longitudinal study of digital trainings and rehabilitation effects. JMIR Ment Health. 2021;8:e30610. doi: 10.2196/30610.
    1. Gutenbrunner C, Blkel A, Eckhardt I, Teixido L. Rehabilitation bei SARS-CoV-2 Infektionen [Rehabilitation for sars-cov-2 infections]. Das Krankenhaus. 2021;113:122–6.
    1. Rubak S, Sandbæk A, Lauritzen T, Christensen B. Motivational interviewing: a systematic review and meta-analysis. Br J Gen Pract. 2005;55:305–312.
    1. Palmer SJ. Long COVID and mental health. Br J Community Nurs. 2021;26:406–409. doi: 10.12968/bjcn.2021.26.8.406.
    1. Döringer S. ‘The problem-centred expert interview’. Combining qualitative interviewing approaches for investigating implicit expert knowledge. Int J Soc Res Methodol. 2021;24:265–278. doi: 10.1080/13645579.2020.1766777.
    1. Lindgren B M, Lundman B, Graneheim UH. Abstraction and interpretation during the qualitative content analysis process. Int J Nurs Stud. 2020;108:103632. 10.1016/j.ijnurstu.2020.103632.
    1. Schreier M. Qualitative content analysis in practice. London: Sage publications; 2012.

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