Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment
August 17, 2010 updated by: Spenshult Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Oskarström, Sweden, S-31392
- Recruiting
- Spenshult Hospital
-
Contact:
- Ingrid Larsson, RN, PhD-stud
- Phone Number: +46-35 2635253
- Email: ingrid.larsson@spenshult.se
-
Contact:
- Stefan Bergman, MD, PhD
- Phone Number: +46-35 2635050
- Email: stefan.bergman@spenshult.se
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Principal Investigator:
- Ingrid Larsson, RN, PhD-stud
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
DAS28 and costs for the clinics respectively.
Time Frame: Baseline at 0 months, 6 months, 12 months
|
Baseline at 0 months, 6 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Baseline at 0 months, 6 months, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Stefan Bergman, MD, PhD, R&D-centre Spenshult
- Principal Investigator: Ingrid Larsson, RN, PhD-stud, R&D-centre Spenshult
- Study Chair: Barbro Arvidsson, RNT, prof, R&D-centre Spenshult
- Study Chair: Bengt Fridlund, RNT, prof, University of Jönköping, Sweden
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Anticipated)
October 1, 2011
Study Completion (Anticipated)
October 1, 2012
Study Registration Dates
First Submitted
October 8, 2009
First Submitted That Met QC Criteria
February 18, 2010
First Posted (Estimate)
February 19, 2010
Study Record Updates
Last Update Posted (Estimate)
August 18, 2010
Last Update Submitted That Met QC Criteria
August 17, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FoUS09001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.