Evaluation of out-patient rehabilitation measures of persisting symptoms caused by a COVID-19 infection (post-COVID) in health care workers
Organizational Data
- DRKS-ID:
- DRKS00033651
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2024-02-15
- Last update in DRKS:
- 2024-04-17
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
In a longitudinal study, insured people of the institution for statutory accident insurance and prevention in the health and welfare services (BGW) are receiving a questionnaire concerning their symptoms, their state of health and the rehabilitation measures at three points of time. The first will be before the start and the second time point will be after completing their rehabilitation measure in out-patient care. To observe the sustainability of the rehabilitation measures, they will be contacted a third time three months after completing the rehabilitation.
Brief summary in scientific language
In a quantitative longitudinal study, insured people of the institution for statutory accident insurance and prevention in the health and welfare services (BGW) are contacted via paper-pencil questionnaire to give information about their symptoms, health-related quality of life and the rehabilitation measures in the stationary and out-patient setting. The study has three measuring point with the first two following a pre-post-design for the out-patient rehabilitation measure and the third time point evaluating the sustainability of the effects by conducting a three-months-follow-up measuring. Additionally, it is planned to conduct focus group interviews with providers of post-COVID rehabilitation.
Health condition or problem studied
- ICD10:
- U09.9 - Post COVID-19 condition, unspecified
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Cases, who receive/will receive/have received an out-patient rehabilitation measure because of a COVID-19 disease. These people receive a quantitative survey at three different measurement points (before and after the out-patient rehabilitation measure, as well as three months after the second measurement) about their symptoms, health-related quality of life and the rehabilitation measure.
Endpoints
- Primary outcome:
- patient-reported post-COVID symptoms measured with the standardised Post-COVID syndrome score (PCS Score) developed by Bahmer et al. (compare: Bahmer, T., et al., Severity, predictors and clinical correlates of Post-COVID syndrome (PCS) in Germany: A prospective, multi-centre, population-based cohort study. eClinicalMedicine, 2022. 51: p. 101549). This instruments includes 12 symptoms that are often reported by patients suffering from PCS. Those symptoms are weighted and summed up in an overall score indicating the severity of their PCS. The score is divided in three categories (no/mild PCS, moderate PCS and severe PCS). This instrument will be used in all three surveys (before and after the out-patient rehabilitation measure, as well as three months after the second measurement).
- Secondary outcome:
- Health-related quality of life measured with SF-12; this instrument shows using two scores the mental and physical quality of life. Also this instrument will be used in all three surveys.
Study Design
- Purpose:
- Treatment
- Retrospective/prospective:
- Both
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- Longitudinal study
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Universitätsklinikum Hamburg-Eppendorf Hamburg
Recruitment period and number of participants
- Planned study start date:
- 2024-03-11
- Actual study start date:
- 2024-04-12
- Planned study completion date:
- 2025-12-31
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 120
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- persisting symptoms after COVID-19 infection (post-COVID) a registered (at BGW) stationary and/or out-patient rehabilitation measure because of COVID-19
Exclusion Criteria
People, who were already contacted and/or surveyed by the BGW for another study on COVID-19 people, whose out-patient rehabilitation has been registered before January 2023
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Hamburg-EppendorfProf. Dr. Uwe Koch-GromusMartinistr. 5220246 HamburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Hamburg-EppendorfProf. Dr. Uwe Koch-GromusMartinistraße 5220246 HamburgGermany
- Telephone:
- 040741054132
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universitätsklinikum Hamburg-EppendorfSvenja MertensMartinistraße 5220246 HamburgGermany
- Telephone:
- 01734446484
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsklinikum Hamburg-EppendorfProf. Dr. Uwe Koch-GromusMartinistraße 5220246 HamburgGermany
- Telephone:
- 040741054132
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
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.)
- Address:
- Berufsgenossenschaft für Gesundheitsdienst und Wohlfahrtspflege22089 HamburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Lokale Psychologische Ethikkommission am Zentrum für Psychosoziale Medizin (LPEK)Martinistraße 5120246 HamburgGermany
- Telephone:
- +49 40 7410 0
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2024-01-31
- Ethics committee number:
- LPEK-0720
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2024-02-11
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- Studienprotokoll
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- 2025
- 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