Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00015526

Trial Description

start of 1:1-Block title

Title

Structured Delegation of Physician Services as Part of a Concept Based Cooperation for the Management of Inflammatory Rheumatic Diseases: study protocol for a multi-center randomized controlled trial

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

Trial Acronym

StarkeR

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

In Germany, the care of patients with rheumatoid arthritis or psoriatic arthritis seems to be capable of improvement. In order to provide better patient care, rheumatology nurses might take over selected tasks.

The StärkeR-project examines nursing consultation. 800 patients with a stable course of rheumatoid arthritis or psoriatic arthritis in 20 centres in North Rhine Westphalia or Lower Saxony will be randomized to either rheumatology care with nursing consultation or standard patient care. Both will be compared concerning the differences between baseline and follow-up after one year regarding disease activity and health related quality of life.

This project comprises the following institutions: Rheumazentrum Ruhrgebiet, BARMER GEK, Koordinierungszentrum für Klinische Studien Marburg, Abteilung für Medizinische Informatik, Biometrie und Epidemiologie, Ruhr-University Bochum

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

Brief Summary in Scientific Language

In Germany, the care of patients with inflammatory arthritis seems to be capable of improvement. In order to provide better patient care, rheumatology nurses might take over selected tasks.

The StärkeR-project examines structured nursing consultation. 800 patients with a stable course of rheumatoid arthritis or psoriatic arthritis in 20 centres in North Rhine Westphalia or Lower Saxony will be randomized to either rheumatology care with nursing consultation or standard patient care. Both will be compared concerning non-inferiority of nursing consultation vs. standard care in the difference of disease activity between baseline and follow-up after one year. Then superiority of nursing consultations in the one year course of health related quality of life will be tested.

This project comprises the following institutions: Rheumazentrum Ruhrgebiet, BARMER GEK, Koordinierungszentrum für Klinische Studien Marburg, Abteilung für Medizinische Informatik, Biometrie und Epidemiologie, Ruhr-University Bochum

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

  •   DRKS00015526
  •   2019/01/11
  •   [---]*
  •   yes
  •   Approved
  •   2018-144-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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

  •   M05.80 -  [generalization M05.8: Other seropositive rheumatoid arthritis]
  •   M06.90 -  [generalization M06.9: Rheumatoid arthritis, unspecified]
  •   M07.30 -  [generalization M07.3: Other psoriatic arthropathies]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Standard patient care by the rheumatologist
  •   Nurse-led care by a qualified rheumatology nurse in cooperation with the rheumatologist
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control (effective treament of control group)
  •   Health care system
  •   Parallel
  •   IV
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

difference of disease activity (measured by the DAS28) between baseline and one year follow-up as well as the difference between these time points regarding EQ-5D-5L (hierarchic testing)

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

Secondary Outcome

patient satisfaction, functional capability, costs (as measured by workload of nurse and physician, respectively), duration of hospitalisation, death.

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

  • Doctor's Practice 
  • Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2018/09/03
  •   600
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

patients with a stable course of rheumatoid arthritis or psoriatic arthritis (polyarticular form)

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

Exclusion Criteria

limited legal competence, insufficient language skills, very active or life threatening disease

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Rheumazentrum Ruhrgebiet
    • Mr.  Prof. Dr  Jürgen  Braun 
    • Claudiusstr. 45
    • 44649  Herne
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Abteilung für medizinische Informatik, Biometrie und Epidemiologie
    • Mr.  Prof.  Hans-J  Trampisch 
    • Universitätsstr. 150
    • 44801  Bochum
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Abteilung für medizinische Informatik, Biometrie und Epidemiologie
    • Mr.  Prof.  Hans-J  Trampisch 
    • Universitätsstr. 150
    • 44801  Bochum
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
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
    • Innovationsausschuss beim G-BA
    • Ms.  Dr.  Maren  Walgenbach 
    • Postfach 12 06 06
    • 10623  Berlin
    • 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 complete, follow-up continuing
  •   [---]*
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.