Trial document



drksid header

  DRKS00029206

Trial Description

start of 1:1-Block title

Title

Outpatient respiratory therapy for patients with post-COVID-19 syndrome - A feasibility study

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The purpose of this study is to test the feasibility of a large-scale study to measure the effects of respiratory therapy on post-COVID syndrome in affected patients. For this purpose, the planned study will be conducted in a smaller format. At the end, the recruitment process will be evaluated and the study participants (physiotherapists and patients) will be interviewed about their experiences with the study materials. In addition, a first effect assessment of the therapy on the post-COVID syndrome will be performed.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

In an explorative non-randomized and non-controlled longitudinal study with quantitative and qualitative data collection, physiotherapeutic respiratory therapy in patients with post-COVID syndrome will be observed over a period of nine weeks. Before and after the observation period, physiotherapeutic respiratory findings and assessments of fatigue, dyspnea, quality of life, activity and participation will be collected.
During the observation period, the implemented therapy contents and occurred adverse events will be documented. During and after the observation period, questionnaires and interviews will be used to assess aspects of the feasibility of a study and the provision of treatment (respiratory therapy). The study is coordinated by Heidelberg University Hospital.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

No

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00029206
  •   2022/06/17
  •   [---]*
  •   yes
  •   Approved
  •   S-359/2022, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   ICD.10 U09.9G: Post-COVID-19 condition, unspecified.
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients with post-COVID syndrome: observation of physiotherapeutic breathing therapy over a period of nine weeks.

    Before and after the observation period, physiotherapeutic respiratory findings and assessments of fatigue, dyspnea, quality of life, activity and participation will be collected.
    During the observation period, the implemented therapy contents and occurred adverse events are documented. During and after the observation period, aspects of the feasibility of a study and the provision of remedies (respiratory therapy) will be recorded by means of questionnaires and interviews.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- recruitment (after completion of recruitment: qualitative survey by means of questionnaire and semi-structured interview).
- compliance (after application of the study documents: qualitative survey by means of questionnaire and semi-structured interview, quantitative survey by means of actual documentation on the documentation forms)
- potential effectiveness (after completion of the study: quantitative survey by means of documentation on the findings sheets and the questionnaires on fatique, dyspnea, activity and participation, and quality of life)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- respiratory therapy content
- safety of study content
- factors influencing access to care and respiratory therapy feasibility

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2022/06/22
  •   30
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patients:
Personal consent to participate in the study, good knowledge of German, onset of symptoms of COVID-19 disease more than twelve weeks ago, physician's prescription for physiotherapy with the diagnosis U09.9, persistent symptoms of post-COVID syndrome (primarily shortness of breath / problems with breathing).

Physical Therapists:
State-recognized professional title of physiotherapist, personal consent to participate in the study, good knowledge of German, work as a physiotherapist in an outpatient setting (practices/rehabilitation centers),
participation in the online information event to introduce the study and the study measures before study inclusion.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Patients:
Poor general health (which does not allow for outpatient treatment), need for home visits, limitations (which do not allow the patient to complete the questionnaires independently, such as dementia), severe lung disease (such as COPD), severe mental illness.

Physical Therapists:
Physical therapists who have had their professional title revoked and/or are unauthorized to use it.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.