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

This study is ongoing, but not recruiting participants.

First Received: November 24, 2006 Last Updated: May 2, 2007 History of Changes

Sponsors and Collaborators:	Diakonhjemmet Sykehus St. Olavs Hospital
Information provided by:	Diakonhjemmet Sykehus
ClinicalTrials.gov Identifier:	NCT00403676

Purpose

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

Condition	Intervention
Arthritis	Procedure: follow up by a clinical nurse or a rheumatologist

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Nursing Consultation in Out-Patient Clinics for Patients With Inflammatory Rheumatic Disease

Further study details as provided by Diakonhjemmet Sykehus:

Primary Outcome Measures:

patient satisfaction [ Time Frame: 12 mnths and 24 mnths ]

Secondary Outcome Measures:

Health related quality of life [ Time Frame: 12 mnths and 24 mnths ]
Disease activity [ Time Frame: 12 mnths and 24 mnths ]
coping [ Time Frame: 12 mnths and 24 mnths ]

Estimated Enrollment:	80
Study Start Date:	September 2005
Estimated Study Completion Date:	August 2008

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 Sykehus

St. Olavs Hospital

Investigators

Study Chair:

Kåre Birger Hagen, PhD

Diakonhjemmet Hospital

More Information

No publications provided

Study ID Numbers:	DiakonhjemmetS
Study First Received:	November 24, 2006
Last Updated:	May 2, 2007
ClinicalTrials.gov Identifier:	NCT00403676 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by Diakonhjemmet Sykehus:

nurse practitioner
rheumatology care
outpatient clinic
patient satisfaction

Study placed in the following topic categories:

Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Rheumatic Diseases

Additional relevant MeSH terms:

Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009