ASAP - Assisted Immediate Augmented Post-/Long-COVID Plan for Patients Infected With COVID-19

NCT05238415 | Completed

• 1 other identifier: ASAP
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

Post-/long-COVID occurs in patients with severe, moderate, and even mild courses. The symptomatology is multi-layered and complex. Patients with mild and moderate courses and especially younger patients are not optimally integrated into one of the existing care structures of COVID outpatient clinics and regular primary care. The diagnosis of post-/long-COVID and a consequent targeted treatment are currently partly not ensured. The variability of symptoms and the resulting complexity of diagnosis and treatment also pose a challenge in rural areas. The aim of the project is an evaluation of a program for low-threshold needs identification and treatment planning for a hybrid (personal supporting counselors and digital trainings) post-/long-COVID care. The contents of the present project include an innovative basis outside the existing standard care for the identification of affected persons. This will be done by means of a low-threshold online screening, which can also be carried out by the affected persons themselves. Furthermore, an intensive interdisciplinary assessment linked to medical rehabilitation resulting in a comprehensive, interdisciplinary, and cross-sectoral treatment plan is a core component of the current project. Finally, the implementation of digital trainings which are accompanied by a personal supporting counselor and augmented by continuously available trainings in the form of digital modules aim to provide general recommendation for the future support of post/long-COVID care. The current research project 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.

Conditions

Long-COVID; Post-COVID; Physiological Impairment; Psychosomatic Disorder; Psychological Distress; Psychological Disease; Psychological Disorder; Psychological Impairment; Psychological Adjustment; Physiological Disease; Physiological Disorder; Physiological Adjustment; Healthy Lifestyle

Keywords

Post-COVID; Long-COVID; treatment plan; eHealth; digital intervention; medical rehabilitation; psychosomatic rehabilitation

Outcome Measures

Primary Outcomes (2)

• Change from baseline in the Post-/ Long-COVID symptoms at 3 months

  The symptom change with regard to Post-/Long-COVID will be evaluated by at least three follow-up measures, using a questionnaire adapted from the COVID-19 Rehabilitation Needs Questionnaire-Health Problems caused by SARS-CoV-2 (Lemhöfer, C., et al. (2021)), with 14 items. Possible scores range from 1 (no problem) to 5 (extreme problem). Change = (Score at measurement points (e.g.,3 months) - Score at baseline)

  Baseline to 3 months

• Subjective prognosis of return to work

  Return to work will be evaluated by at least one follow-up measure, e.g., T2 (2 weeks from baseline), T4 (8 weeks from baseline). The questionnaire is adapted to the context of COVID-19 from the SPE scale (Mittag, O., \& Raspe, H. (2003)), with 4 items.

  2 weeks, 8 weeks

Secondary Outcomes (4)

• Activity and social participation

  2 weeks, 8 weeks

• Health behaviors of daily living

  2 weeks, 8 weeks

• Mental health

  2 weeks, 8 weeks

• Life satisfaction

  2 weeks, 8 weeks

Study Arms (3)

Control group receiving no Post-/Long-COVID assessment

NO INTERVENTION

Questionnaires at timepoints t1 (screening), t2 (one week later), t3 (before the intervention), t4 (after the intervention), t5 (6 weeks after intervention), t6 (6 months after the intervention) Patients from Bavaria Germany: Contact to personal pilots and digital health interventions.

Intervention group receiving a Post-/Long-COVID assessment

EXPERIMENTAL

Questionnaires at timepoints t1 (screening), t2 (one week later), t3 (before the intervention), t4 (after the intervention), t5 (6 weeks after intervention), t6 (6 months after the intervention) Patients from Bavaria Germany: Assessment in clinics for post-/long-COVID, contact to personal pilots and digital health interventions.

Diagnostic Test: Psychological and Physiological Assessments

Comparison group receiving no Post-/Long-COVID assessment

NO INTERVENTION

Questionnaires at timepoints t1 (screening), t2 (comparable to t2 in the other groups), t3 (comparable with t4 in the other groups), t3 (comparable to t5 in the other groups) Patients from Germany: No intervention at all

Interventions

Psychological and Physiological Assessments DIAGNOSTIC_TEST

About N = 60 patients admitted to the study receive a 3-day assessment (a further examination) at the Kiliani-Klinik Bad Windsheim which considers physical and psychological parameters relevant for the diagnosis of a Post-/ Long-COVID Syndrom.

Intervention group receiving a Post-/Long-COVID assessment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All people who are resident in Bavaria can participate in the intervention and control group. In the comparison group all people who live and work in Germany can take part
• working age
• ability to participate in surveys (e.g., sufficient German language skills)
• willingness to participate in outpatient or (partially) inpatient therapy
• ability to undergo rehabilitation if necessary, and a telephone and Internet connection
• suspicion of post-/long-COVID

You may not qualify if:

• Contraindications regarding physical exercise,
• not being of age,
• illiteracy
• massively limited cognitive abilities (linguistic components of the digital offerings must be able to be used and questionnaires completed or interviews participated in)

Sponsors & Collaborators

• Prof. Dr. Sonia Lippke: lead
• Dr. Becker Hospital Group: collaborator
• Dr. Becker Kiliani Clinic: collaborator
• Dr. Becker Clinic Möhnesee: collaborator
• Johannesbad Reha Clinics Bad Füssing: collaborator
• Reha-Centre Bad Kötzting: collaborator

Study Sites (1)

Dr. Becker Klinikgruppe

Cologne, 50968, Germany

Location

Related Publications (24)

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  PMID: 32252591 BACKGROUND

• Cai X, Hu X, Ekumi IO, Wang J, An Y, Li Z, Yuan B. Psychological Distress and Its Correlates Among COVID-19 Survivors During Early Convalescence Across Age Groups. Am J Geriatr Psychiatry. 2020 Oct;28(10):1030-1039. doi: 10.1016/j.jagp.2020.07.003. Epub 2020 Jul 10.

  PMID: 32753338 BACKGROUND

• - Dahmen A, Gao L, Keller FM, Becker P & Lippke S. Psychosomatische Nachsorge: Curriculum Hannover online vs. Curriculum Hannover und vs. Care as Usual. Vortrag im Rahmen des DRV-Kolloquiums 2021.

  BACKGROUND

• - Dahmen A & Becker P. Abschlussbericht des Umsetzungsprojektes Curriculum Hannover-Online - Studien zur Wirksamkeit und Äquivalenz einer internetbasierten Virtual-Classroom-Intervention zur psychosomatischen Nachsorge nach dem Curriculum Hannover, o.a.

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• - DIMDI. ICF - Internationale Klassifikation der Funktionsfähigkeit, Behinderung und Gesundheit. WHO, Genf, 2005.

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• - Gutenbrunner C et al., Rehabilitation bei und nach SARS-CoV-2 Infektionen. das Krankenhaus 112 (2021): 02.

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• Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, Kang L, Guo L, Liu M, Zhou X, Luo J, Huang Z, Tu S, Zhao Y, Chen L, Xu D, Li Y, Li C, Peng L, Li Y, Xie W, Cui D, Shang L, Fan G, Xu J, Wang G, Wang Y, Zhong J, Wang C, Wang J, Zhang D, Cao B. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021 Jan 16;397(10270):220-232. doi: 10.1016/S0140-6736(20)32656-8. Epub 2021 Jan 8.

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• - Kassenärztliche Bundesvereinigung (KBV). Versichertenbefragung der Kassenärztlichen Bundesvereinigung 2021. FGW Forschungsgruppe Wahlen Telefonfeld GmbH, Mannheim, 2021.

  BACKGROUND

• Keller FM, Dahmen A, Derksen C, Kotting 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 Aug 26;8(8):e30610. doi: 10.2196/30610.

  PMID: 34270444 BACKGROUND

• - Klapsa, K. Die Angst, dass Long-COVID-Patienten das Gesundheitssystem überfordern. https://www.welt.de/politik/deutschland/article230250123/Rehakliniken-Erleben-massive-Zunahme-von-Long-Covid-Patienten.html, 16.04.2021 (Zugriff am: 14.09.2021)

  BACKGROUND

• - Kluge et al., S3-Leitlinie - Empfehlungen zur stationären Therapie von Patienten mit COVID-19. AWMF-Register Nr. 113/001, 2021.

  BACKGROUND

• - Koczulla AR et al. S1-Leitlinie Post-COVID/Long-COVID, AWMF-Register Nr. 020/027, 2021.

  BACKGROUND

• Mazza C, Ricci E, Biondi S, Colasanti M, Ferracuti S, Napoli C, Roma P. A Nationwide Survey of Psychological Distress among Italian People during the COVID-19 Pandemic: Immediate Psychological Responses and Associated Factors. Int J Environ Res Public Health. 2020 May 2;17(9):3165. doi: 10.3390/ijerph17093165.

  PMID: 32370116 BACKGROUND

• Nalbandian A, Sehgal K, Gupta A, Madhavan MV, McGroder C, Stevens JS, Cook JR, Nordvig AS, Shalev D, Sehrawat TS, Ahluwalia N, Bikdeli B, Dietz D, Der-Nigoghossian C, Liyanage-Don N, Rosner GF, Bernstein EJ, Mohan S, Beckley AA, Seres DS, Choueiri TK, Uriel N, Ausiello JC, Accili D, Freedberg DE, Baldwin M, Schwartz A, Brodie D, Garcia CK, Elkind MSV, Connors JM, Bilezikian JP, Landry DW, Wan EY. Post-acute COVID-19 syndrome. Nat Med. 2021 Apr;27(4):601-615. doi: 10.1038/s41591-021-01283-z. Epub 2021 Mar 22.

  PMID: 33753937 BACKGROUND

• - National Institute of Health, NIH Plans Research on "Long COVID". https://covid19.nih.gov/news-and-stories/research-on-long-covid, 2021.

  BACKGROUND

• Paterson RW, Brown RL, Benjamin L, Nortley R, Wiethoff S, Bharucha T, Jayaseelan DL, Kumar G, Raftopoulos RE, Zambreanu L, Vivekanandam V, Khoo A, Geraldes R, Chinthapalli K, Boyd E, Tuzlali H, Price G, Christofi G, Morrow J, McNamara P, McLoughlin B, Lim ST, Mehta PR, Levee V, Keddie S, Yong W, Trip SA, Foulkes AJM, Hotton G, Miller TD, Everitt AD, Carswell C, Davies NWS, Yoong M, Attwell D, Sreedharan J, Silber E, Schott JM, Chandratheva A, Perry RJ, Simister R, Checkley A, Longley N, Farmer SF, Carletti F, Houlihan C, Thom M, Lunn MP, Spillane J, Howard R, Vincent A, Werring DJ, Hoskote C, Jager HR, Manji H, Zandi MS. The emerging spectrum of COVID-19 neurology: clinical, radiological and laboratory findings. Brain. 2020 Oct 1;143(10):3104-3120. doi: 10.1093/brain/awaa240.

  PMID: 32637987 BACKGROUND

• - Schlitt A, Schultz K, Platz T. AWMF-Leitlinie: Rehabilitation nach einer COVID-19-Erkrankung. Dtsch Ärztebl 2021; 118: A774.

  BACKGROUND

• - Schmädeke S et al. Abschlussbericht des Umsetzungsprojekts Rehabilitationsnachsorge für depressive Patientinnen und Patienten mit einer Smartphone-App (DE-RENA) - Akzeptanz, Wirksamkeit und Empfehlungen, o.a.

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• Seecheran R, Narayansingh R, Giddings S, Rampaul M, Furlonge K, Abdool K, Bhagwandass N, Seecheran NA. Atrial Arrhythmias in a Patient Presenting With Coronavirus Disease-2019 (COVID-19) Infection. J Investig Med High Impact Case Rep. 2020 Jan-Dec;8:2324709620925571. doi: 10.1177/2324709620925571.

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• Venkatesan P. NICE guideline on long COVID. Lancet Respir Med. 2021 Feb;9(2):129. doi: 10.1016/S2213-2600(21)00031-X. Epub 2021 Jan 13. No abstract available.

  PMID: 33453162 BACKGROUND

• - WIdO, Ein Jahr Covid-19-bedingte Fehlzeiten am Arbeitsplatz: Jeder zwölfte betroffene Beschäftigte musste stationär behandelt werden, Pressemitteilung, 2021.

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• - Wolf, S. and Erdös, J. for the Belgian Health Care Knowledge Centre (KCE). Epidemiology of long COVID: a preliminary report. Deutsche Kurzfassung zum gleichnamigen KCE-Bericht. AIHTA Projektbericht Nr. 135a; 2021. Wien: Austrian Institute for Health Technology Assessment GmbH.

  BACKGROUND

• Derksen C, Rinn R, Gao L, Dahmen A, Cordes C, Kolb C, Becker P, Lippke S. Longitudinal Evaluation of an Integrated Post-COVID-19/Long COVID Management Program Consisting of Digital Interventions and Personal Support: Randomized Controlled Trial. J Med Internet Res. 2023 Oct 4;25:e49342. doi: 10.2196/49342.

  PMID: 37792437 DERIVED

• Dahmen A, Keller FM, Derksen C, Rinn R, Becker P, Lippke S. 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. BMC Infect Dis. 2022 Aug 15;22(1):693. doi: 10.1186/s12879-022-07584-z.

  PMID: 35971066 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Psychophysiologic Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Sonia Lippke, Prof. Dr.

  Jacobs University Bremen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Health Psychology and Behavioral Medicine

Model Details: This study has three study arms. Specifically, patients will be randomly assigned to an intervention group or an active control group. Furthermore, a comparison group will be recruited. Whereas the CompG will not receive any treatment, the IG and the ACG will have contacts with a personal pilot who will help the patients to navigate through the study as well as through treatment options and help them seek help for further needs. Aditionally, the intervention group will receive a so called 3-day assessment in a clinic and in which patients will be assessed by a multiprofessional team of health care professionals regarding their post-/long-COVID symptoms.

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 14, 2022
• Study Start: December 15, 2021
• Primary Completion: December 15, 2022
• Study Completion: June 30, 2023
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)