Teleconsultation for patients with postviral symptoms
| ISRCTN | ISRCTN11050086 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11050086 |
| ClinicalTrials.gov (NCT) | Nil knows |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | ZMII2-2524FSB031 |
| Sponsor | Bundesverwaltungsamt |
| Funder | German Federal Ministry of Health |
- Submission date
- 04/03/2025
- Registration date
- 28/04/2025
- Last edited
- 10/09/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Long- and post-COVID stands for various health complaints that patients suffer from after they have survived a SARS-CoV-2 primary infection. The most common long-term symptoms include persistent fatigue, dyspnoea, but also cardiovascular and neurological complaints. The symptoms can persist, reappear or fluctuate after the initial recovery from an acute SARS-CoV-2 infection. Long- and post-COVID is therefore a complex disease with long-lasting, heterogeneous symptoms. The disease can be a major challenge, especially for those in employment, making it considerably more difficult to return to work. Comprehensive treatment of those affected requires interprofessional structures and networks, which only exist to a limited extent in Germany to date. This is particularly true for rural and structurally weak regions. Patients experience care bottlenecks in diagnosis, further treatment and outpatient follow-up care after rehabilitation stays. This trial is being conducted to investigate the extent to which an interprofessional, patient-centred teleconsultation, initiated and accompanied by the general practitioner (GP), helps to reduce the symptoms of patients with long-COVID and other post-viral symptom complexes. At the centre of this intervention is the interprofessional exchange between GPs and long-COVID specialists at Rostock University Medical Center (Long-COVID Board) and the direct involvement of patients via teleconsultation. On the one hand, this approach enables patients to receive care close to home in familiar structures. On the other hand, the specific experience and expertise of the specialists in the treatment of long-COVID and other post-viral complaints enriches the diagnosis and treatment of the patients included. The aim is a focussed and efficient evidence-based differential diagnosis and, depending on the participatory decision-making process, the application of elaborated therapeutic approaches.
Who can participate?
Patients from participating GP practices in Mecklenburg-Vorpommern (Germany) who are at least 18 years old and suffer from a post-viral symptom complex can take part in the study.
What does the study involve?
At the beginning of the study and four months later, all included patients visit their GP practice for data collection (physical performance, health-related quality of life, cognitive impairment, lung performance and fatigue symptoms). For patients in the intervention group, a teleconsultation takes place between the two appointments at the GP practice, during which they and their GP discuss the diagnosis and treatment options with a representative of the Long-COVID Board. Patients in the control group receive care as usual.
What are the possible benefits and risks of participation?
Prompt interprofessional dialogue between specialists, GPs and patients can help to improve diagnosis and access to treatment. As diagnosis and treatment are carried out according to current guidelines and procedures, no harm to the patient is to be expected.
Where is the study run from?
Institute for General Practice, Rostock University Medical Center (Germany)
When is the study starting and how long is it expected to run for?
November 2024 to December 2028
Who is funding the study?
German Federal Ministry of Health
Who is the main contact?
Dr Christin Löffler, christin.loeffler@med.uni-rostock.de
Contact information
Public, Scientific
Doberaner Str. 142
Rostock
18057
Germany
 ORCID ID |
0000-0001-5763-7588 |
|---|---|
| Phone | +49 381 494 2481 |
| christin.loeffler@med.uni-rostock.de |
Principal investigator
Ernst-Heydemann-Str. 6
Rostock
18057
Germany
| Phone | +49 381 494 7511 |
|---|---|
| Emil.Reisinger@med.uni-rostock.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional cluster-randomized controlled |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | Patient-centred interprofessional teleconsultation for patients with postviral symptom complexes (Subproject of, "Coordinated LongCOVID care system for integrated supply and capacity expansion in Mecklenburg-Western Pomerania (COVI-Care M-V)") |
| Study acronym | COVI-Care M-V |
| Study objectives | The trial tests whether the COVI-Care M-V intervention (interprofessional, patient-centred teleconsultation, initiated and accompanied by the general practitioner (GP) with long-COVID specialists from Rostock University Medical Center (Long-COVID Board) is more effective in improving physical performance among patients than care as usual. |
| Ethics approval(s) |
Approved 05/02/2025, Ethics Committee at Rostock University Medical Center (St.-Georg Str. 108, Rostock, 18055, Germany; +49 381 494 9900; ethik@med.uni-rostock.de), ref: A2025-0033 |
| Health condition(s) or problem(s) studied | Long- and post-COVID and other post-viral symptom complexs |
| Intervention | Interprofessional, patient-centred teleconsultation initiated and supervised by the GP with the patient and GP at one end (GP practice) and Long-COVID specialists from Rostock University Medical Center (Long-COVID board) at the other end. |
| Intervention type | Other |
| Primary outcome measure(s) | Physical performance measured using the target and actual value of the walking distance of the 6-minute walk test between patient inclusion (T0) and 4 months later (T1) |
| Key secondary outcome measure(s) | The following secondary outcome measures are assessed before the intervention (T0) and four months later (T1): 1. Health-related quality of life measured using the Post Acute COVID-19 Quality of Life (PAC-19QoL) tool 2. Cognitive impairment measured using the DemTect screening test 3. Lung performance measured using a peak flow meter 4. Symptoms of fatigue measured using the Fatigue Assessment Scale (FAS) |
| Completion date | 31/12/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 240 |
| Key inclusion criteria | Patients: 1. Presence of a post-viral symptom complex 2. Age from at least 18 years Physicians: 1. General practitioners based in Mecklenburg-Western Pomerania (Germany) |
| Key exclusion criteria | Patient exclusion criteria: 1. Presence of an acute underlying malignant disease 2. Remaining life expectancy of less than 12 months as assessed by a GP 3. Language barriers (e.g. hearing impairment, lack of language skills) 4. Dementia and lack of capacity to give consent |
| Date of first enrolment | 01/04/2026 |
| Date of final enrolment | 31/12/2027 |
Locations
Countries of recruitment
- Germany
Study participating centre
Rostock
18057
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Christin Löffler, christin.loeffler@med.uni-rostock.de. Raw data will be available on request following publication of results in 2029. Informed consent will be obtained during patient enrolment. Data will be anonymised. An inter-institutional data sharing agreement will be required. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 09/09/2025 | 10/09/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/09/2025: Publication reference added.
04/03/2025: Study's existence confirmed by the Ethics Committee at Rostock University Medical Center.
