Back to resultsNursing Consultation in Out-patient Clinics for Patients With Inflammatory Rheumatic Disease
Primary Purpose
Arthritis
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Follow up bu a nurse
Follow up by a medical doctor
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis focused on measuring nurse practitioner, rheumatology care, outpatient clinic, patient satisfaction
Eligibility Criteria
Inclusion Criteria:
- Patients with inflammatory arthropathies monitored after starting disease modifying antirheumatic drugs.
Sites / Locations
- St. Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Follow up by nurse
follow up by medical doctor
Arm Description
Patient randomized for follow-up by a nurse
Patients randomized for follow up by a medical doctor
Outcomes
Primary Outcome Measures
patient satisfaction
Secondary Outcome Measures
Health related quality of life
Disease activity
coping
Full Information
NCT ID
NCT00403676
First Posted
November 24, 2006
Last Updated
June 27, 2012
Sponsor
Diakonhjemmet Hospital
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00403676
Brief Title
Nursing Consultation in Out-patient Clinics for Patients With Inflammatory Rheumatic Disease
Official Title
Nursing Consultation in Out-patient Clinics for Patients With Inflammatory Rheumatic Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diakonhjemmet Hospital
Collaborators
St. Olavs Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the effectiveness and acceptability of care given by nurse specialists in out patient clinics, through a randomized controlled study.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis
Keywords
nurse practitioner, rheumatology care, outpatient clinic, patient satisfaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Follow up by nurse
Arm Type
Experimental
Arm Description
Patient randomized for follow-up by a nurse
Arm Title
follow up by medical doctor
Arm Type
Experimental
Arm Description
Patients randomized for follow up by a medical doctor
Intervention Type
Other
Intervention Name(s)
Follow up bu a nurse
Intervention Description
Follow up bu a nurse
Intervention Type
Other
Intervention Name(s)
Follow up by a medical doctor
Intervention Description
Follow up by a medical doctor
Primary Outcome Measure Information:
Title
patient satisfaction
Time Frame
12 mnths and 24 mnths
Secondary Outcome Measure Information:
Title
Health related quality of life
Time Frame
12 mnths and 24 mnths
Title
Disease activity
Time Frame
12 mnths and 24 mnths
Title
coping
Time Frame
12 mnths and 24 mnths
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with inflammatory arthropathies monitored after starting disease modifying antirheumatic drugs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kåre Birger Hagen, PhD
Organizational Affiliation
Diakonhjemmet Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
St. Olavs Hospital
City
Trondheim
ZIP/Postal Code
7020
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
23393144
Citation
Koksvik HS, Hagen KB, Rodevand E, Mowinckel P, Kvien TK, Zangi HA. Patient satisfaction with nursing consultations in a rheumatology outpatient clinic: a 21-month randomised controlled trial in patients with inflammatory arthritides. Ann Rheum Dis. 2013 Jun;72(6):836-43. doi: 10.1136/annrheumdis-2012-202296. Epub 2013 Feb 7.
Results Reference
derived
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Nursing Consultation in Out-patient Clinics for Patients With Inflammatory Rheumatic Disease
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