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

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 - StaerkeR

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00015526

Enrollment

600

Registered

2019-01-11

Start date

2018-09-03

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M05.80 M06.90 M07.30

Interventions

Group 1: Standard patient care by the rheumatologist Group 2: Nurse-led care by a qualified rheumatology nurse in cooperation with the rheumatologist

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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)	—

Secondary

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

Countries

Germany

Contacts

Public ContactHans-J Trampisch

Abteilung für medizinische Informatik, Biometrie und Epidemiologie

hans.j.trampisch@rub.de0049 234 32 27790

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 28, 2026