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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Spenshult Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
The Swedish Rheumatism Ass
County Council of Halland, Sweden
Information provided by:
Spenshult Hospital
ClinicalTrials.gov Identifier:
NCT01071447
First received: October 8, 2009
Last updated: August 17, 2010
Last verified: August 2010

October 8, 2009
August 17, 2010
October 2009
October 2011   (final data collection date for primary outcome measure)
DAS28 and costs for the clinics respectively. [ Time Frame: Baseline at 0 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01071447 on ClinicalTrials.gov Archive Site
HAQ (Health Assessment Questionnaire), VAS-pain (Visual Analog Scale), VAS-global health, VAS-satisfaction, VAS-security/trust, Tender joints, swollen joints, Quality of life-EQ5D, Effective consumer survey 17, Inflammatory parameters in blood. [ Time Frame: Baseline at 0 months, 6 months, 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment
Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment:a Randomized Controlled Trial Comparing Nurse-led Clinic Versus Rheumatologist Clinic

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.

Aim To compare nurse-led clinic and rheumatologist-led clinic regarding results of treatment, and health economic costs.

Intervention Rheumatologist-led clinic: The subjects are seeing a rheumatologist after six months and after 12-months of intervention and have the possibility to contact the rheumatology clinic.

Nurse-led clinic: The subjects are seeing a rheumatology nurse after six months and a rheumatologist after 12 months of intervention and have the possibility to contact the rheumatology nurse during the intervention.

Outcome measures:

Main outcome: DAS28 and costs for the clinics respectively.

Secondary outcome: HAQ (Health Assessment Questionnaire), VAS-pain (Visual Analog Scale), VAS-global health, VAS-satisfaction, VAS-security/trust, Tender joints, swollen joints, Quality of life-EQ5D, Effective consumer survey 17, Inflammatory parameters in blood.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Rheumatic Diseases
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.
Other Names:
  • Nurse-led clinic
  • Rheumatologist-led clinic
  • Active Comparator: Rheumatologist-led clinic
    Rheumatologist-led clinic: The subjects are seeing a rheumatologist after six months and after 12-months of intervention and have the possibility to contact the rheumatology clinic
    Intervention: Other: Nurse-led clinic vs rheumatologist-led clinic
  • Experimental: Nurse-led clinic
    The subjects are seeing a rheumatology nurse after six months and a rheumatologist after 12 months of intervention and have the possibility to contact the rheumatology nurse during the intervention.
    Intervention: Other: Nurse-led clinic vs rheumatologist-led clinic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
October 2012
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with rheumatologic diseases and biological treatment with a DAS28 of 3.2 or less

Exclusion Criteria:

  • The subjects should not have problems with infections due to treatment
  • Subjects with difficulties speaking and/or reading swedish
Both
Not Provided
No
Contact: Stefan Bergman, MD, PhD +46-35 2635250 stefan.bergman@spenshult.se
Contact: Ingrid Larsson, RN, PhD-stud +46-35 2635253 ingrid.larsson@spenshult.se
Sweden
 
NCT01071447
FoUS09001
Yes
Stefan Bergman, Research Director, R&D-centre Spenshult Hospital
Spenshult Hospital
  • The Swedish Rheumatism Ass
  • County Council of Halland, Sweden
Principal Investigator: Ingrid Larsson, RN, PhD-stud R&D-centre Spenshult
Study Director: Stefan Bergman, MD, PhD R&D-centre Spenshult
Study Chair: Barbro Arvidsson, RNT, prof R&D-centre Spenshult
Study Chair: Bengt Fridlund, RNT, prof University of Jönköping, Sweden
Spenshult Hospital
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP