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Nursing Consultation in Out-patient Clinics for Patients With Inflammatory Rheumatic Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00403676
Recruitment Status : Completed
First Posted : November 27, 2006
Last Update Posted : June 28, 2012
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Hege Svean Koksvik, Diakonhjemmet Hospital

Study Description
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Brief Summary:
Evaluate the effectiveness and acceptability of care given by nurse specialists in out patient clinics, through a randomized controlled study.

Condition or disease Intervention/treatment Phase
Arthritis Other: Follow up bu a nurse Other: Follow up by a medical doctor Not Applicable

Detailed Description:

This study is part of a national multicenter study (NOR-DMARD) that aims to measure the longterm safety and effectiveness of disease modifying therapies in inflammatory arthropathies. The Nor-Dmard study is a comparative, phase IV, longitudinal, observational study. All patients starting a DMARD regime are enrolled. Patients from two clinics (different parts of Norway) will be randomised to receive follow-up care from either a clinical nurse or a rheumatologist.

The primary outcome measure is patient satisfaction measured by Leeds Satisfaction Questionnaire.

The secondary outcome is effectiveness measured by Coping (CORS),Health related quality of life (SF-36) and Disease activity (MHAQ, DAS-28).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nursing Consultation in Out-patient Clinics for Patients With Inflammatory Rheumatic Disease
Study Start Date : September 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008
Arms and Interventions
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Arm Intervention/treatment
Experimental: Follow up by nurse
Patient randomized for follow-up by a nurse
 Other: Follow up bu a nurse
Follow up bu a nurse
Experimental: follow up by medical doctor
Patients randomized for follow up by a medical doctor
 Other: Follow up by a medical doctor
Follow up by a medical doctor


Outcome Measures
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Primary Outcome Measures :
  1. patient satisfaction [ Time Frame: 12 mnths and 24 mnths ]

Secondary Outcome Measures :
  1. Health related quality of life [ Time Frame: 12 mnths and 24 mnths ]
  2. Disease activity [ Time Frame: 12 mnths and 24 mnths ]
  3. coping [ Time Frame: 12 mnths and 24 mnths ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with inflammatory arthropathies monitored after starting disease modifying antirheumatic drugs.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00403676


Locations
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Norway
St. Olavs Hospital
Trondheim, Norway, 7020
Sponsors and Collaborators
Diakonhjemmet Hospital
St. Olavs Hospital
Investigators
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Study Chair: Kåre Birger Hagen, PhD Diakonhjemmet Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hege Svean Koksvik, Research Nurse, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier: NCT00403676    
Other Study ID Numbers: DiakonhjemmetS
First Posted: November 27, 2006    Key Record Dates
Last Update Posted: June 28, 2012
Last Verified: June 2012
Keywords provided by Hege Svean Koksvik, Diakonhjemmet Hospital:
nurse practitioner
rheumatology care
outpatient clinic
patient satisfaction
Additional relevant MeSH terms:
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Rheumatic Diseases
Collagen Diseases
Musculoskeletal Diseases
Connective Tissue Diseases