Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment
Recruitment status was Recruiting
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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 |
- DAS28 and costs for the clinics respectively. [ Time Frame: Baseline at 0 months, 6 months, 12 months ] [ Designated as safety issue: No ]
- 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:
|
|
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:
|
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 |
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| 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 | |
| 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 | |
| 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 Musculoskeletal Diseases Connective Tissue Diseases |
ClinicalTrials.gov processed this record on May 21, 2013