Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention
Rheumatic Diseases
Other: Nurse-led clinic vs rheumatologist-led clinic

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment:a Randomized Controlled Trial Comparing Nurse-led Clinic Versus Rheumatologist Clinic

Further study details as provided by Spenshult Hospital:

Primary Outcome Measures:
  • DAS28 and costs for the clinics respectively. [ Time Frame: Baseline at 0 months, 6 months, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: October 2009
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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.
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

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01071447

Contacts
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

Locations
Sweden
Spenshult Hospital Recruiting
Oskarström, Sweden, S-31392
Contact: Stefan Bergman, MD, PhD    +46-35 2635050    stefan.bergman@spenshult.se   
Contact: Ingrid Larsson, RN, PhD-stud    +46-35 2635253    ingrid.larsson@spenshult.se   
Principal Investigator: Ingrid Larsson, RN, PhD-stud         
Sponsors and Collaborators
Spenshult Hospital
The Swedish Rheumatism Ass
County Council of Halland, Sweden
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Stefan Bergman, Research Director, R&D-centre Spenshult Hospital
ClinicalTrials.gov Identifier: NCT01071447     History of Changes
Other Study ID Numbers: FoUS09001
Study First Received: October 8, 2009
Last Updated: August 17, 2010
Health Authority: Sweden: Institutional Review Board

Keywords provided by Spenshult Hospital:
Rheumatic diseases
Biologic treatment
Nurse-led

Additional relevant MeSH terms:
Rheumatic Diseases
Connective Tissue Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 25, 2014