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

NCT ID: NCT00403676

Last Updated: 2012-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-08-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Follow up by nurse

Patient randomized for follow-up by a nurse

Group Type EXPERIMENTAL

Follow up bu a nurse

Intervention Type OTHER

Follow up bu a nurse

follow up by medical doctor

Patients randomized for follow up by a medical doctor

Group Type EXPERIMENTAL

Follow up by a medical doctor

Intervention Type OTHER

Follow up by a medical doctor

Interventions

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Follow up bu a nurse

Follow up bu a nurse

Intervention Type OTHER

Follow up by a medical doctor

Follow up by a medical doctor

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with inflammatory arthropathies monitored after starting disease modifying antirheumatic drugs.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Diakonhjemmet Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hege Svean Koksvik

Research Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kåre Birger Hagen, PhD

Role: STUDY_CHAIR

Diakonhjemmet Hospital

Locations

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St. Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 23393144 (View on PubMed)

Other Identifiers

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DiakonhjemmetS

Identifier Type: -

Identifier Source: org_study_id

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