Nursing Consultation in Out-patient Clinics for Patients With Inflammatory Rheumatic Disease
Evaluate the effectiveness and acceptability of care given by nurse specialists in out patient clinics, through a randomized controlled study.
|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|
- patient satisfaction [ Time Frame: 12 mnths and 24 mnths ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||September 2005|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
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
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00403676
|St. Olavs Hospital|
|Trondheim, Norway, 7020|
|Study Chair:||Kåre Birger Hagen, PhD||Diakonhjemmet Hospital|