Trial document




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  DRKS00023642

Trial Description

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Title

Medical Rehabilitation after Coronavirus Disease (Covid-19)/ Re_Co

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Trial Acronym

Re_Co

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URL of the Trial

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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.

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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 five rehab facilities, rehabilitants are consecutively included in the study.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00023642
  •   2020/12/01
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  •   yes
  •   Approved
  •   20-391, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

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Health Condition or Problem studied

  •   Covid-19 (ICD-10 U07.1)
  •   J45 -  Asthma
  •   J44 -  Other chronic obstructive pulmonary disease
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Interventions/Observational Groups

  •   The rehabilitants receive pneumological rehabilitation and rehabilitation aftercare.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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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

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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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2021/02/05
  •   580
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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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.

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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.

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Addresses

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    • Institut für Sozialmedizin und Epidemiologie, Universität zu Lübeck
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Institut für Sozialmedizin und Epidemiologie, Universität zu Lübeck
    • Ms.  Prof. Dr.  Ruth  Deck 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Institut für Sozialmedizin und Epidemiologie, Universität zu Lübeck
    • Ms.  Prof. Dr.  Ruth  Deck 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Rentenversicherung Bund
    • Ruhrstraße 2
    • 10709  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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