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

This study has been completed.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Hege Svean Koksvik, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier:
NCT00403676
First received: November 24, 2006
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention
Arthritis
Other: Follow up bu a nurse
Other: Follow up by a medical doctor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nursing Consultation in Out-patient Clinics for Patients With Inflammatory Rheumatic Disease

Further study details as provided by Diakonhjemmet Hospital:

Primary Outcome Measures:
  • patient satisfaction [ Time Frame: 12 mnths and 24 mnths ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health related quality of life [ Time Frame: 12 mnths and 24 mnths ] [ Designated as safety issue: No ]
  • Disease activity [ Time Frame: 12 mnths and 24 mnths ] [ Designated as safety issue: No ]
  • coping [ Time Frame: 12 mnths and 24 mnths ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: September 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with inflammatory arthropathies monitored after starting disease modifying antirheumatic drugs.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00403676

Locations
Norway
St. Olavs Hospital
Trondheim, Norway, 7020
Sponsors and Collaborators
Diakonhjemmet Hospital
St. Olavs Hospital
Investigators
Study Chair: Kåre Birger Hagen, PhD Diakonhjemmet Hospital
  More Information

No publications provided by Diakonhjemmet Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hege Svean Koksvik, Research Nurse, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier: NCT00403676     History of Changes
Other Study ID Numbers: DiakonhjemmetS
Study First Received: November 24, 2006
Last Updated: June 27, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Diakonhjemmet Hospital:
nurse practitioner
rheumatology care
outpatient clinic
patient satisfaction

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

ClinicalTrials.gov processed this record on April 23, 2014