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Telemedicine follow-up of hospitalized patients with coronavirus disease-2019 (COVID-19).

Organizational Data

DRKS-ID:
DRKS00022244
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2021-02-25
Last update in DRKS:
2023-03-23
Registration type:
Retrospective

Acronym/abbreviation of the study

Telemed5000-Covid-19

URL of the study

http://telemed5000.de

Brief summary in lay language

This is a single-arm, prospective, multicenter, open-label, non-controlled, observational study. The study will enroll 100 hospitalized patients with coronavirus disease-2019 (COVID-19) who will be followed up telemedically for 1 year. Patients will receive home measuring medical devices and measure their vital signs 1x daily (ECG, weight, blood pressure, oxygen saturation, self-assessement), record a voice sample 1x weekly, and perform a 6-minute activity measurement 1x monthly. The trial is part of the research and development project Telemed5000 which is supported by the German Federal Ministry of Economic Affairs and Energy.

Brief summary in scientific language

The primary study objective is to follow up patients suffering from COVID-19 after hospitalization for a period of 1 year by the daily recording of vital signs (ECG, blood pressure, oxygen saturation, self-assessment, weight) weekly voice recording and monthly measurement of physical activity. The aim is to find out whether daily measurements can detect worsening of existing chronic diseases, secondary diseases and emergencies. It will also explore whether voice or a 6-minute activity test can be used to detect deterioration in health at an early stage.

Health condition or problem studied

ICD10:
U07.1 - COVID-19, virus identified
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Telemedical follow-up: From the day of training at home by nurses, the patient measures their body weight, blood pressure, oxygen saturation, an ECG and enters their condition on the tablet 1x each day. 1x a week, each patient records an approx. 2-minute voice sample via an app on the tablet. For this purpose, the patient is guided through 4 short voice tasks. On the day of device training and at device pick-up, a TMZ specialist nurse conducts a 6-minute walk test with each patient outside the patient's home and measures the distance the patient can walk in 6 minutes using a measuring wheel and the received tablet. In the course of the one-year follow-up, each patient is asked to perform a 6-minute activity test with the tablet on his/her own 1x/month if he/she feels healthy enough to do so. Patients will be called and reminded 1x/month for this. All data are transmitted via Bluetooth (except ECG, which is directly transmitted) from the measuring devices to the tablet and sent to a server of the TMZ in the Charité via mobile network in an encrypted manner.

Endpoints

Primary outcome:
Number of unplanned clinical events (emergency telemedicine interventions, emergency department presentations, unplanned hospitalizations, death from any cause) as a composite endpoint during 1 year of telemedicine follow-up of hospitalized COVID-19- patients.
Secondary outcome:
1.Days lost due to unplanned hospitalizations and death from any cause during one-year follow-up. 2.total mortality 3.number of unplanned hospitalizations 4.number of emergency department presentations 5.Number of telemedicine interventions for emergencies 6.changes in quality of life during follow-up 7.number of TMZ-contacts to the patient due to abnormal telemonitoring findings. 8.number of TMZ contacts to primary care physicians due to abnormal telemonitoring findings 9.adherence to telemonitoring

Study Design

Purpose:
Diagnostic
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Berlin
  • Medical center Bernau
  • Medical center Ruppiner Kliniken Neuruppin
  • Medical center Unfallkrankenhaus Berlin Berlin
  • Medical center Merseburg

Recruitment period and number of participants

Planned study start date:
2021-02-18
Actual study start date:
2021-02-18
Planned study completion date:
No Entry
Actual Study Completion Date:
2023-02-16
Target Sample Size:
100
Final Sample Size:
113

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
1.Hospitalization with detection of SARS-CoV-2 RNA (PCR) in naso-/oropharyngeal swab (hospital discharge letter available). 2.age of majority 3.written informed consent of the patient

Exclusion Criteria

1.inability or unwillingness to measure daily vital signs (e.g., dementia, blindness, deafness, wheelchair use, inadequate German language skills, speech or voice disorders that interfere with voice analysis, limited informal self-determination) 2.participation in therapy studies (observational studies and registries are possible).

Addresses

Primary Sponsor

Charité - Universitätsmedizin Berlin CharitéCentrum 11 für Herz-Kreislauf-Medizin Arbeitsbereich Kardiovaskuläre Telemedizin
Prof. Dr. med. Friedrich Köhler
Charitéplatz 1
10117 Berlin
Germany
Telephone:
+49 30 450 514184
Fax:
+49 30 450 7 514112
Contact per E-Mail
URL:
http://telemedizin.charite.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Charité - Universitätsmedizin Berlin CharitéCentrum 11 für Herz-, Kreislauf- und Gefäßmedizin Arbeitsbereich Kardiovaskuläre Telemedizin
Prof. Dr. Friedrich Köhler
Charitéplatz 1
10117 Berlin
Germany
Telephone:
030/450514184
Fax:
No Entry
Contact per E-Mail
URL:
http://telemedizin.charite.de

Contact for Public Queries

Charité - Universitätsmedizin Berlin CharitéCentrum 11 für Herz-, Kreislauf- und Gefäßmedizin Arbeitsbereich Kardiovaskuläre Telemedizin
Charitéplatz 1
10117 Berlin
Germany
Telephone:
030/450514440
Fax:
030/4507514440
Contact per E-Mail
URL:
No Entry

Principal Investigator

Charité - Universitätsmedizin Berlin CharitéCentrum 11 für Herz-, Kreislauf- und Gefäßmedizin Arbeitsbereich Kardiovaskuläre Telemedizin
Prof. Dr. Friedrich Köhler
Charitéplatz 1
10117 Berlin
Germany
Telephone:
030/450514184
Fax:
No Entry
Contact per E-Mail
URL:
http://telemedizin.charite.de

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Bundesministerium für Wirtschaft und Klimaschutz
11019 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
https://www.bmwi.de/

Ethics Committee

Address Ethics Committee

Ethikkommission der Charité – Universitätsmedizin Berlin
Charitéplatz 1
10117 Berlin
Germany
Telephone:
(+49)30-450517222
Fax:
(+49)30-450517952
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2021-01-04
Ethics committee number:
EA1/002/21
Vote of the Ethics Committee:
Approved
Date of the vote:
2021-01-20

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
Possible upon request and depending of the research question.

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry