Medical Rehabilitation after Coronavirus Disease (Covid-19)/ Re_Co
Organizational Data
- DRKS-ID:
- DRKS00023642
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2020-12-01
- Last update in DRKS:
- 2024-01-08
- Registration type:
- Prospective
Acronym/abbreviation of the study
Re_Co
URL of the study
No Entry
Brief summary in lay language
Due to the novelty of Covid-19 disease, there have been few studies on rehabilitation measures for this patient group to date. The question arises which contents are used during the rehabilitation of Covid-19 patients and which long-term consequences of the disease can be observed in the rehabilitants. The fact that rehabilitation has positive effects in the case of a pneumological disease has already been proven in COPD and asthma rehabilitants. The aim of this study is to describe the long-term consequences of the rehabilitants after Covid-19 disease and to subsequently formulate recommendations for rehabilitation.
Brief summary in scientific language
Due to the novelty of Covid-19 disease, little is known about the necessary contents and structures of subsequent rehabilitation. Due to suspected long-term consequences of Covid-19 disease, scientific studies on the subject of rehabilitation with Covid-19 are being called for. After intensive care and / or respiration, patients need to learn in rehabilitation how to cope with the psychological, cognitive and physical consequences before returning home. The aim of this study is to derive recommendations for tailored rehabilitation concepts for patients with varying degrees of participation restrictions and psychological stress after Covid-19 disease and to explore suitable aftercare strategies. To be able to classify the findings, the rehabilitants will be compared to a group of COPD and asthma patients. In a prospective, explorative, multi-centre observational study, the study participants are interviewed at four points in time (start of rehabilitation, end of rehabilitation, 6 and 12 month follow-up). In four rehab facilities, rehabilitants are consecutively included in the study.
Health condition or problem studied
- Free text:
- U08.9 U09.9! U10.9
- ICD10:
- J45 - Asthma
- ICD10:
- J44 - Other chronic obstructive pulmonary disease
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- The rehabilitants receive pneumological rehabilitation and rehabilitation aftercare.
Endpoints
- Primary outcome:
- Participation (Index to Measure Impairment of Participation, IMET) at the start of rehabilitation and after 6 and 12 months; Quality of Life (VR12) at the start of rehabilitation, after rehabilitation and after 6 and 12 months
- Secondary outcome:
- At all four measurement points (start of rehab, after rehab and after 6 and 12 months) the following outcomes are assessed Depressiveness, anxiety, stress (DASS); stress-related psychomental limitations and disorders (GAD-7; PHQ-9; ITQ part 1); corona-associated life events (single items); effects of chronic obstructive pulmonary disease (CAT); fatigue (EORTC-FA 12); general health (individual items); performance in different areas of life (QGmR); assessment of work ability (Work Ability Score WAS); subjective prognosis of employment (PES scale) Occupational changes (through individual questions from the QGmR) are recorded after 6 and 12 months
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- Prospective
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- Longitudinal study
- 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):
-
- Medical center MEDIAN Klinik Heiligendamm Heiligendamm
- Medical center Ostseeklinik Schönberg-Holm Schönberg-Holm
- Medical center Reha-Zentrum Schömberg Schömberg
- Medical center MEDIAN Klinik Flechtingen Flechtingen
Recruitment period and number of participants
- Planned study start date:
- 2021-02-01
- Actual study start date:
- 2021-02-05
- Planned study completion date:
- 2023-11-30
- Actual Study Completion Date:
- 2023-11-30
- Target Sample Size:
- 580
- Final Sample Size:
- 542
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 65 Years
- Additional Inclusion Criteria:
- The study will include insured persons who are eligible for work after different severity of covid-19 disease (ICD: U07.1!). They no longer require isolation and are between 18 and 65 years old. Study participants in the comparison group have a diagnosed obstructive respiratory disease such as bronchial asthma or COPD with a comparable age range and a comparable distribution in terms of gender and ability to work.
Exclusion Criteria
Rehabilitants with insufficient knowledge of German are excluded from the study. The costs of rehabilitation may not be borne by the employers' liability insurance association. In addition, discontinuation of the rehabilitation measure and lack of consent to participate in the study are exclusion criteria.
Addresses
Primary Sponsor
- Address:
- Institut für Sozialmedizin und Epidemiologie, Universität zu LübeckRatzeburger Allee 16023538 LübeckGermany
- 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:
- Institut für Sozialmedizin und Epidemiologie, Universität zu LübeckProf. Dr. Ruth DeckRatzeburger Allee 16023538 LübeckGermany
- Telephone:
- 0451 500 51211
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Institut für Sozialmedizin und Epidemiologie, Universität zu LübeckProf. Dr. Ruth DeckRatzeburger Allee 16023538 LübeckGermany
- Telephone:
- 0451 500 51211
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Institut für Sozialmedizin und Epidemiologie, Universität zu LübeckProf. Dr. Ruth DeckRatzeburger Allee 16023538 LübeckGermany
- Telephone:
- 0451 500 51211
- 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:
- Deutsche Rentenversicherung BundRuhrstraße 210709 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Med. Fakultät der Universität zu LübeckRatzeburger Allee 16023538 LübeckGermany
- Telephone:
- +49-451-5004639
- Fax:
- +49-451-5003026
- 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:
- 2020-09-30
- Ethics committee number:
- 20-391
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-11-05
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:
- Studieprotokoll ReCo
- 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:
- Mercedes Rutsch , Jördis Frommhold , Heike Buhr-Schinner , Thomas Gross , Per Otto Schüller , Ruth Deck (2023): Pneumologische Rehabilitation bei Long Covid – Gesundheitliche Veränderungen am Ende der stationären Rehabilitationsmaßnahme. Die Rehabilitation.
- Date of first publication of study results:
- 2023-01-17
- DRKS entry published for the first time with results:
- 2023-04-27
Basic reporting
- Basic Reporting / Results tables:
- Rutsch M, Deck R. Medizinische Rehabilitation bei Post-COVID-Syndrom – gesundheitliche und berufliche Veränderungen im Zeitverlauf. Deutsche Rentenversicherung. 2023;1:27-51.
- Rutsch M, Deck R. Berufliche Belastungen von Long-Covid-Rehabilitand*innen und Rückkehr zur Arbeit nach einer pneumologischen Rehabilitation. Rehabilitation (Stuttg). 2023;62(06):369-78. DOI: 10.1055/a-2105-5810
- Brief summary of results:
- No Entry