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Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment

NCT01071447 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2010-08-18

No results posted yet for this study

Summary

Randomized controlled trial including 100 subjects with rheumatic diseases and biological treatment with a 28 point-Disease Activity Score(DAS28)3.2 or less. The subjects will be randomized to either nurse-led clinic or rheumatologist-led clinic. The hypothesis is that there will be no difference in DAS28 between the two groups after 1 year follow-up.

Conditions

  • Rheumatic Diseases

Interventions

OTHER

Nurse-led clinic vs rheumatologist-led clinic

The subjects are seeing a rheumatology nurse (experimental arm)instead of a rheumatologist (active comparator arm) after six months. Subjects in both arms are seeing a rheumatologist after 12 months and have the possibility to contact the rheumatology nurse.

Sponsors & Collaborators

  • The Swedish Rheumatism Ass

    collaborator OTHER

  • County Council of Halland, Sweden

    collaborator OTHER_GOV

  • Spenshult Hospital

    lead OTHER

Principal Investigators

  • Ingrid Larsson, RN, PhD-stud · R&D-centre Spenshult

  • Stefan Bergman, MD, PhD · R&D-centre Spenshult

  • Barbro Arvidsson, RNT, prof · R&D-centre Spenshult

  • Bengt Fridlund, RNT, prof · University of Jönköping, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-10-31
Completion
2012-10-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01071447 on ClinicalTrials.gov