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

Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403676
• Other study ID #: DiakonhjemmetS
• Status: Completed
• Phase: N/A
• First received: November 24, 2006
• Last updated: June 27, 2012
• Start date: September 2005
• Est. completion date: August 2008

Study information

• Verified date: June 2012
• Source: Diakonhjemmet Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with inflammatory arthropathies monitored after starting disease modifying antirheumatic drugs.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Rheumatic Diseases

Intervention

Other:
• Follow up bu a nurse
Follow up bu a nurse
• Follow up by a medical doctor
Follow up by a medical doctor

Locations

Country	Name	City	State
Norway	St. Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient satisfaction		12 mnths and 24 mnths	No
Secondary	Health related quality of life		12 mnths and 24 mnths	No
Secondary	Disease activity		12 mnths and 24 mnths	No
Secondary	coping		12 mnths and 24 mnths	No