Teleconsultation for patients with postviral symptoms

ISRCTN	ISRCTN11050086
DOI	https://doi.org/10.1186/ISRCTN11050086
ClinicalTrials.gov number	Nil knows
Secondary identifying numbers	ZMII2-2524FSB031

Submission date: 04/03/2025
Registration date: 28/04/2025
Last edited: 28/04/2025

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

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

Study website

Contact information

Dr Christin Löffler
Public, Scientific

Doberaner Str. 142
Rostock
18057
Germany

ORCID ID	0000-0001-5763-7588
Phone	+49 381 494 2481
Email	christin.loeffler@med.uni-rostock.de

Prof Emil Christian Reisinger
Principal Investigator

Ernst-Heydemann-Str. 6
Rostock
18057
Germany

Phone	+49 381 494 7511
Email	Emil.Reisinger@med.uni-rostock.de

Study information

Study design	Interventional cluster-randomized controlled
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	GP practice, Hospital, Medical and other records, Telephone
Study type	Diagnostic, Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a 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 hypothesis	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
Condition	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	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)
Secondary outcome measures	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)
Overall study start date	01/11/2024
Overall study end date	31/12/2028

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	18 Years
Upper age limit	99 Years
Sex	Both
Target number of participants	A total of 240 patients from 42 GP practices in Mecklenburg-Vorpommern (Germany) will be recruited. The practices will be cluster-randomised so that approximately half of the patients will be assigned to the intervention group and the other half to the control group.
Participant 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)
Participant 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
Recruitment start date	01/04/2026
Recruitment end date	31/12/2027

Locations

Countries of recruitment

Germany

Study participating centre

Rostock University Medical Center, Institute of General Practice

Doberaner Str.142
Rostock
18057
Germany

Sponsor information

Bundesverwaltungsamt
Government

Eupener Str. 125
Köln
50933
Germany

Phone	+49 228 99358-24124
Email	tobias.kujath@bva.bund.de
Website	www.bundesverwaltungsamt.de

Funders

Funder type

Not defined

German Federal Ministry of Health

No information available

Results and Publications

Intention to publish date	01/09/2029
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a peer-reviewed journal.
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.

Editorial Notes

04/03/2025: Study's existence confirmed by the Ethics Committee at Rostock University Medical Center.