Long-COVIDASAPNCT05238415
ASAP - Assisted Immediate Augmented Post-/Long-COVID Plan for Patients Infected With COVID-19
A study testing Psychological and Physiological Assessments in people with Long-COVID and Post-COVID, run by Prof. Dr. Sonia Lippke at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Long-COVID, Post-COVID, Psychosomatic Disorder
- What is being tested?
- Psychological and Physiological Assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteGermany
- Study dates
- 15 Dec 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ASAP - Assisted Immediate Augmented Post-/Long-COVID Plan
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.
Read more
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.
Read the detailed description
The goal is the long-term and sustainable holistic treatment and support of patients with post-/long-COVID to prevent long-term illness and chronification. Following the earliest possible, low-threshold identification of post-/long-COVID sufferers, an intensive multidisciplinary assessment is conducted, resulting in holistic treatment planning based on the results of the assessment. This consists of recommendations for a coordinated, interdisciplinary therapy plan. At the same time, digital therapy offers are recommended and made available to patients. Patients are accompanied by a supporting counselor (personal pilot) who guides them through the entire care process. This closes the gap between acute care of COVID-19 and outpatient therapy or rehabilitation of post-/long-COVID.
To identify patients with post-/long-COVID symptoms, a low-threshold scientifically based online-screening that confirms the presence of post-/long-COVID syndrome and an three day inpatient assessment that determines the need for further treatment will be developed, validated and prepared for standard care. Long-term goals are the dissemination of the validated instruments to diagnose post-long-COVID and treatment approaches (interdisciplinary, individualized treatment plan) through communication to key stakeholders such as medical associations, health insurance companies, service providers in the outpatient and inpatient sector, as well as professional societies and care institutions. This is intended to improve patient care and make care delivery of treatments for post-/long-COVID patients more efficient beyond the project duration.
Standard care currently diagnoses post-/long-COVID and provides recommendations for treatment through primary care practices and specialized post-COVID outpatient clinics. Both access routes inadequately reach those affected especially in rural areas. Long-/post-COVID outpatient clinics are primarily located in metropolitan areas and are therefore mainly available to the population in large cities. In particular, young affected individuals who have had little to no prior outpatient care due to a very mild course do not have primary care and often do not have the knowledge of the specific post-/long-COVID symptomatology and potentially seek insufficient and delayed medical support. This may result in aggravation and possibly chronification of symptoms and consequent long-term disability/ incapacity with limited participation. This in turn can have a negative impact on the continuation or resumption of work and lead to economic burdens for the whole society.
The contents of the present project include, as an innovative basis outside the existing standard care, the low-threshold identification of affected persons, an intensive interdisciplinary assessment resulting in a comprehensive, interdisciplinary and cross-sectoral treatment plan, the implementation of which is controlled and accompanied by a personal supporting counselor and augmented by continuously available training in the form of digital offers.
The following research questions and hypotheses will be investigated with this project and subsequently communicated to the various stakeholders and the general public:
- What screening tool can reliably identify patients suffering from post/long-COVID syndrome? Hypothesis: With a simplified screening, the presence of post/long-COVID can be identified in a low-threshold manner.
- Which assessments can be used to reliably determine the need for therapy or rehabilitation and the leading rehabilitation indication? Hypothesis: With a comprehensive assessment, the need for rehabilitation and the leading rehabilitation indication can be determined validly and reliably.
- What must digital therapy offerings look like to benefit patients with post/long-COVID syndrome? Hypothesis: Digital therapy offerings with an individualizable focus achieve the best success in the treatment of post/long-COVID.
- What information must the supporting counselor have to ensure management of interdisciplinary treatment? Hypothesis: As a point of contact for all stakeholders, a supporting counselor will have interdisciplinary and intersectoral treatment planning available to ensure sustained management of interdisciplinary treatment.
- How should an interdisciplinary treatment pathway look like in the long term? Hypothesis: An interdisciplinary treatment pathway must guide the patient, with the support of the supporting counselor, in such a way that he or she experiences the appropriate diagnosis and treatment for him or herself and actively participates in recovery so that he or she recovers quickly and sustainably from his or her post/long-COVID disease, increases his or her functional capacity, reduces incapacity to work, and regains participation.
The project aims to optimize care for post-/long-COVID patients and empower them to participate socially. Affected individuals are supported on their way to the appropriate therapeutic and rehabilitative care by expert staff, the supporting counselors (personal pilots), and receive interdisciplinary multi-professional treatment focused on individual complaints. Affected individuals are accompanied and supported through digital interventions. The low-threshold access via an online-screening leads to the elimination of information loss and inhibitions. Various digital services, such as DiGAs, video consultations, as well as aftercare services are increasingly used. This is of particular benefit to patients who have tight schedules and/or live in rural regions with a low density of doctors/therapists.
- Conditions
- Long-COVID, Post-COVID, Psychosomatic Disorder, Psychological Distress, Psychological Disease, Psychological Disorder
- Being tested
- Psychological and Physiological Assessments
- Keywords
- Post-COVID, Long-COVID, treatment plan, eHealth, digital intervention, medical rehabilitation, psychosomatic rehabilitation
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Psychophysiologic Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological and Physiological AssessmentsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 2 weeks, 8 weeks
Secondary outcomes (4)
Activity and social participation
Social participation will be evaluated by at least one follow-up measure, e.g., T2 (2 weeks from baseline), T4 (8 weeks from baseline), using a questionnaire adapted from the COVID-19 Rehabilitation Needs Questionnaire-Activity and participation (Lemhöfer, C., et al. (2021)), with 12 items. Possible scores range from 1 (Never) to 5 (Often/always).
Measured: 2 weeks, 8 weeks
Health behaviors of daily living
Health behaviors of daily living including physical activity and nutrition consumption behavior, and sedentary behavior will be evaluated by at least one follow-up measure, e.g., T2 (2 weeks from baseline), T4 (8 weeks from baseline). The physical activity and nutrition consumption questionnaire is adapted from the Physical Activity and Fruit and Vegetable Consumption Questionnaire (Lippke, S., et al. (2009)), with 2 items. The sedentary behavior questionnaire is adapted from the International Physical Activity Questionnaire (Craig, C. L.,et al. (2003)), with 2 Items.
Measured: 2 weeks, 8 weeks
Mental health
Mental health including loneliness, psychological distress, stress, depression and anxiety will be evaluated by at least one follow-up measure, e.g., T2 (2 weeks from baseline), T4 (8 weeks from baseline). The loneliness questionnaire is adapted from the UCLA loneliness scale (Russell, D. (1996)), with 2 items. The psychological distress will be assessed by Peri-traumatic Distress Scale (Qiu, J. et al. (2020)), with 24 items. The stress questionnaire is adapted from the PSS-4 (Cohen, S. (1988)), with 4 items. The depression and anxiety questionnaire is adapted from the PHQ-4 (Löwe, B.,et al. (2010)), with 4 items.
Measured: 2 weeks, 8 weeks
Life satisfaction
Life satisfaction will be evaluated by at least one follow-up measure, e.g., T2 (2 weeks from baseline), T4 (8 weeks from baseline), using a questionnaire adapted from the General Satisfaction with Life Questionnaire (Beierlein, C., et al. (2015)), with 4 items. Possible scores range from 1 (totally unsatisfied) to 4 (very satisfied).
Measured: 2 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start15 Dec 2021
- Primary completion15 Dec 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Long-COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Sonia Lippke
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Becker Hospital Group, Dr. Becker Kiliani Clinic, Dr. Becker Clinic Möhnesee, Johannesbad Reha Clinics Bad Füssing, Reha-Centre Bad Kötzting
- Responsible party
- Sponsor-investigator, Prof. Dr. Sonia Lippke, Jacobs University Bremen gGmbH
- Investigators
- Sonia Lippke, Prof. Dr., Principal investigator, Jacobs University Bremen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238415
- Sponsor's protocol ID
- ASAP
- Acronym
- ASAP
- Status last verified
- Apr 2026
- First submitted
- 10 Feb 2022
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be published. Other researchers are welcome to get in contact with the PI to get access to anonymous data.
Publications
Akhmerov A, Marban E. COVID-19 and the Heart. Circ Res. 2020 May 8;126(10):1443-1455. doi: 10.1161/CIRCRESAHA.120.317055. Epub 2020 Apr 7.
PubMed 32252591Cai 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.
PubMed 32753338- 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.
- 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.
Seidel M. [The International Classification of Functioning, Disability and Health]. Nervenarzt. 2005 Jan;76(1):79-90; quiz 91-2. doi: 10.1007/s00115-004-1855-8. German.
PubMed 15624112- Gutenbrunner C et al., Rehabilitation bei und nach SARS-CoV-2 Infektionen. das Krankenhaus 112 (2021): 02.
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.
PubMed 33428867- Kassenärztliche Bundesvereinigung (KBV). Versichertenbefragung der Kassenärztlichen Bundesvereinigung 2021. FGW Forschungsgruppe Wahlen Telefonfeld GmbH, Mannheim, 2021.
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.
PubMed 34270444- 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)
Kluge S, Janssens U, Welte T, Weber-Carstens S, Schalte G, Spinner CD, Malin JJ, Gastmeier P, Langer F, Wepler M, Westhoff M, Pfeifer M, Rabe KF, Hoffmann F, Bottiger BW, Weinmann-Menke J, Kersten A, Berlit P, Haase R, Marx G, Karagiannidis C. [S2k Guideline - Recommendations for Inpatient Therapy of Patients with COVID-19]. Pneumologie. 2021 Feb;75(2):88-112. doi: 10.1055/a-1334-1925. Epub 2021 Jan 15. German.
PubMed 33450783Koczulla AR, Ankermann T, Behrends U, Berlit P, Boing S, Brinkmann F, Franke C, Glockl R, Gogoll C, Hummel T, Kronsbein J, Maibaum T, Peters EMJ, Pfeifer M, Platz T, Pletz M, Pongratz G, Powitz F, Rabe KF, Scheibenbogen C, Stallmach A, Stegbauer M, Wagner HO, Waller C, Wirtz H, Zeiher A, Zwick RH. [S1 Guideline Post-COVID/Long-COVID]. Pneumologie. 2021 Nov;75(11):869-900. doi: 10.1055/a-1551-9734. Epub 2021 Sep 2. German.
PubMed 34474488Mazza 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.
PubMed 32370116Nalbandian 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.
PubMed 33753937- National Institute of Health, NIH Plans Research on "Long COVID". https://covid19.nih.gov/news-and-stories/research-on-long-covid, 2021.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASAP - Assisted Immediate Augmented Post-/Long-COVID Plan
- ClinicalTrials.gov ID
- NCT05238415
- Acronym / sponsor ID
- ASAP / ASAP
- Conditions
- Long-COVID, Post-COVID, Psychosomatic Disorder, Psychological Distress, Psychological Disease, Psychological Disorder
- Keywords
- Post-COVID, Long-COVID, treatment plan, eHealth, digital intervention, medical rehabilitation, psychosomatic rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Prof. Dr. Sonia LippkeUniversity, hospital or other
- Collaborators
- Dr. Becker Hospital Group, Dr. Becker Kiliani Clinic, Dr. Becker Clinic Möhnesee, Johannesbad Reha Clinics Bad Füssing, Reha-Centre Bad Kötzting
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The goal is the long-term and sustainable holistic treatment and support of patients with post-/long-COVID to prevent long-term illness and chronification. Following the earliest possible, low-threshold identification of post-/long-COVID sufferers, an intensive multidisciplinary assessment is conducted, resulting in holistic treatment planning based on the results of the assessment. This consists of recommendations for a coordinated, interdisciplinary therapy plan. At the same time, digital therapy offers are recommended and made available to patients. Patients are accompanied by a supporting counselor (personal pilot) who guides them through the entire care process. This closes the gap between acute care of COVID-19 and outpatient therapy or rehabilitation of post-/long-COVID.
To identify patients with post-/long-COVID symptoms, a low-threshold scientifically based online-screening that confirms the presence of post-/long-COVID syndrome and an three day inpatient assessment that determines the need for further treatment will be developed, validated and prepared for standard care. Long-term goals are the dissemination of the validated instruments to diagnose post-long-COVID and treatment approaches (interdisciplinary, individualized treatment plan) through communication to key stakeholders such as medical associations, health insurance companies, service providers in the outpatient and inpatient sector, as well as professional societies and care institutions. This is intended to improve patient care and make care delivery of treatments for post-/long-COVID patients more efficient beyond the project duration.
Standard care currently diagnoses post-/long-COVID and provides recommendations for treatment through primary care practices and specialized post-COVID outpatient clinics. Both access routes inadequately reach those affected especially in rural areas. Long-/post-COVID outpatient clinics are primarily located in metropolitan areas and are therefore mainly available to the population in large cities. In particular, young affected individuals who have had little to no prior outpatient care due to a very mild course do not have primary care and often do not have the knowledge of the specific post-/long-COVID symptomatology and potentially seek insufficient and delayed medical support. This may result in aggravation and possibly chronification of symptoms and consequent long-term disability/ incapacity with limited participation. This in turn can have a negative impact on the continuation or resumption of work and lead to economic burdens for the whole society.
The contents of the present project include, as an innovative basis outside the existing standard care, the low-threshold identification of affected persons, an intensive interdisciplinary assessment resulting in a comprehensive, interdisciplinary and cross-sectoral treatment plan, the implementation of which is controlled and accompanied by a personal supporting counselor and augmented by continuously available training in the form of digital offers.
The following research questions and hypotheses will be investigated with this project and subsequently communicated to the various stakeholders and the general public:
- What screening tool can reliably identify patients suffering from post/long-COVID syndrome? Hypothesis: With a simplified screening, the presence of post/long-COVID can be identified in a low-threshold manner.
- Which assessments can be used to reliably determine the need for therapy or rehabilitation and the leading rehabilitation indication? Hypothesis: With a comprehensive assessment, the need for rehabilitation and the leading rehabilitation indication can be determined validly and reliably.
- What must digital therapy offerings look like to benefit patients with post/long-COVID syndrome? Hypothesis: Digital therapy offerings with an individualizable focus achieve the best success in the treatment of post/long-COVID.
- What information must the supporting counselor have to ensure management of interdisciplinary treatment? Hypothesis: As a point of contact for all stakeholders, a supporting counselor will have interdisciplinary and intersectoral treatment planning available to ensure sustained management of interdisciplinary treatment.
- How should an interdisciplinary treatment pathway look like in the long term? Hypothesis: An interdisciplinary treatment pathway must guide the patient, with the support of the supporting counselor, in such a way that he or she experiences the appropriate diagnosis and treatment for him or herself and actively participates in recovery so that he or she recovers quickly and sustainably from his or her post/long-COVID disease, increases his or her functional capacity, reduces incapacity to work, and regains participation.
The project aims to optimize care for post-/long-COVID patients and empower them to participate socially. Affected individuals are supported on their way to the appropriate therapeutic and rehabilitative care by expert staff, the supporting counselors (personal pilots), and receive interdisciplinary multi-professional treatment focused on individual complaints. Affected individuals are accompanied and supported through digital interventions. The low-threshold access via an online-screening leads to the elimination of information loss and inhibitions. Various digital services, such as DiGAs, video consultations, as well as aftercare services are increasingly used. This is of particular benefit to patients who have tight schedules and/or live in rural regions with a low density of doctors/therapists.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Diagnostic Test: Psychological and Physiological AssessmentsQuestionnaires 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. |
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological and Physiological AssessmentsAbout 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. | Diagnostic test | Intervention group receiving a Post-/Long-COVID assessment |
Primary outcome
Change from baseline in the Post-/ Long-COVID symptoms at 3 months
Time frame: Baseline to 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)
Subjective prognosis of return to work
Time frame: 2 weeks, 8 weeks
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.
4 secondary outcomes
Activity and social participation
Time frame: 2 weeks, 8 weeks
Health behaviors of daily living
Time frame: 2 weeks, 8 weeks
Mental health
Time frame: 2 weeks, 8 weeks
Life satisfaction
Time frame: 2 weeks, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Background: PubMed 32252591Akhmerov A, Marban E. COVID-19 and the Heart. Circ Res. 2020 May 8;126(10):1443-1455. doi: 10.1161/CIRCRESAHA.120.317055. Epub 2020 Apr 7.
- Background: PubMed 32753338Cai 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.
- 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.
- Background: PubMed 15624112Seidel M. [The International Classification of Functioning, Disability and Health]. Nervenarzt. 2005 Jan;76(1):79-90; quiz 91-2. doi: 10.1007/s00115-004-1855-8. German.
- Background- Gutenbrunner C et al., Rehabilitation bei und nach SARS-CoV-2 Infektionen. das Krankenhaus 112 (2021): 02.
- Background: PubMed 33428867Huang 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.
- Background- Kassenärztliche Bundesvereinigung (KBV). Versichertenbefragung der Kassenärztlichen Bundesvereinigung 2021. FGW Forschungsgruppe Wahlen Telefonfeld GmbH, Mannheim, 2021.
- Background: PubMed 34270444Keller 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.
- 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: PubMed 33450783Kluge S, Janssens U, Welte T, Weber-Carstens S, Schalte G, Spinner CD, Malin JJ, Gastmeier P, Langer F, Wepler M, Westhoff M, Pfeifer M, Rabe KF, Hoffmann F, Bottiger BW, Weinmann-Menke J, Kersten A, Berlit P, Haase R, Marx G, Karagiannidis C. [S2k Guideline - Recommendations for Inpatient Therapy of Patients with COVID-19]. Pneumologie. 2021 Feb;75(2):88-112. doi: 10.1055/a-1334-1925. Epub 2021 Jan 15. German.
- Background: PubMed 34474488Koczulla AR, Ankermann T, Behrends U, Berlit P, Boing S, Brinkmann F, Franke C, Glockl R, Gogoll C, Hummel T, Kronsbein J, Maibaum T, Peters EMJ, Pfeifer M, Platz T, Pletz M, Pongratz G, Powitz F, Rabe KF, Scheibenbogen C, Stallmach A, Stegbauer M, Wagner HO, Waller C, Wirtz H, Zeiher A, Zwick RH. [S1 Guideline Post-COVID/Long-COVID]. Pneumologie. 2021 Nov;75(11):869-900. doi: 10.1055/a-1551-9734. Epub 2021 Sep 2. German.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be published. Other researchers are welcome to get in contact with the PI to get access to anonymous data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia Lippke, Prof. Dr. principal investigator
Jacobs University Bremen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological and Physiological Assessments in people with Long-COVID and Post-COVID, run by Prof. Dr. Sonia Lippke at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Post-/ Long-COVID symptoms at 3 months (time frame: Baseline to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05238415, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.