Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment

NCT ID: NCT01071447

Last Updated: 2010-08-18

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-10-31

Brief Summary

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Randomized controlled trial including 100 subjects with rheumatic diseases and biological treatment with a 28 point-Disease Activity Score(DAS28)3.2 or less. The subjects will be randomized to either nurse-led clinic or rheumatologist-led clinic. The hypothesis is that there will be no difference in DAS28 between the two groups after 1 year follow-up.

Detailed Description

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Aim To compare nurse-led clinic and rheumatologist-led clinic regarding results of treatment, and health economic costs.

Intervention Rheumatologist-led clinic: The subjects are seeing a rheumatologist after six months and after 12-months of intervention and have the possibility to contact the rheumatology clinic.

Nurse-led clinic: The subjects are seeing a rheumatology nurse after six months and a rheumatologist after 12 months of intervention and have the possibility to contact the rheumatology nurse during the intervention.

Outcome measures:

Main outcome: DAS28 and costs for the clinics respectively.

Secondary outcome: HAQ (Health Assessment Questionnaire), VAS-pain (Visual Analog Scale), VAS-global health, VAS-satisfaction, VAS-security/trust, Tender joints, swollen joints, Quality of life-EQ5D, Effective consumer survey 17, Inflammatory parameters in blood.

Conditions

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Rheumatic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Rheumatologist-led clinic

Rheumatologist-led clinic: The subjects are seeing a rheumatologist after six months and after 12-months of intervention and have the possibility to contact the rheumatology clinic

Group Type ACTIVE_COMPARATOR

Nurse-led clinic vs rheumatologist-led clinic

Intervention Type OTHER

The subjects are seeing a rheumatology nurse (experimental arm)instead of a rheumatologist (active comparator arm) after six months. Subjects in both arms are seeing a rheumatologist after 12 months and have the possibility to contact the rheumatology nurse.

Nurse-led clinic

The subjects are seeing a rheumatology nurse after six months and a rheumatologist after 12 months of intervention and have the possibility to contact the rheumatology nurse during the intervention.

Group Type EXPERIMENTAL

Nurse-led clinic vs rheumatologist-led clinic

Intervention Type OTHER

The subjects are seeing a rheumatology nurse (experimental arm)instead of a rheumatologist (active comparator arm) after six months. Subjects in both arms are seeing a rheumatologist after 12 months and have the possibility to contact the rheumatology nurse.

Interventions

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Nurse-led clinic vs rheumatologist-led clinic

The subjects are seeing a rheumatology nurse (experimental arm)instead of a rheumatologist (active comparator arm) after six months. Subjects in both arms are seeing a rheumatologist after 12 months and have the possibility to contact the rheumatology nurse.

Intervention Type OTHER

Other Intervention Names

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Nurse-led clinic Rheumatologist-led clinic

Eligibility Criteria

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Inclusion Criteria

* Subjects with rheumatologic diseases and biological treatment with a DAS28 of 3.2 or less

Exclusion Criteria

* The subjects should not have problems with infections due to treatment
* Subjects with difficulties speaking and/or reading swedish
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Swedish Rheumatism Ass

OTHER

Sponsor Role collaborator

County Council of Halland, Sweden

OTHER_GOV

Sponsor Role collaborator

Spenshult Hospital

OTHER

Sponsor Role lead

Responsible Party

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R&D-centre Spenshult Hospital

Principal Investigators

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Ingrid Larsson, RN, PhD-stud

Role: PRINCIPAL_INVESTIGATOR

R&D-centre Spenshult

Stefan Bergman, MD, PhD

Role: STUDY_DIRECTOR

R&D-centre Spenshult

Barbro Arvidsson, RNT, prof

Role: STUDY_CHAIR

R&D-centre Spenshult

Bengt Fridlund, RNT, prof

Role: STUDY_CHAIR

University of Jönköping, Sweden

Locations

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Spenshult Hospital

Oskarström, Oskarström, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Stefan Bergman, MD, PhD

Role: CONTACT

+46-35 2635250

Ingrid Larsson, RN, PhD-stud

Role: CONTACT

+46-35 2635253

Facility Contacts

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Stefan Bergman, MD, PhD

Role: primary

+46-35 2635050

Ingrid Larsson, RN, PhD-stud

Role: backup

+46-35 2635253

References

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Larsson I, Fridlund B, Arvidsson B, Teleman A, Svedberg P, Bergman S. A nurse-led rheumatology clinic versus rheumatologist-led clinic in monitoring of patients with chronic inflammatory arthritis undergoing biological therapy: a cost comparison study in a randomised controlled trial. BMC Musculoskelet Disord. 2015 Nov 16;16:354. doi: 10.1186/s12891-015-0817-6.

Reference Type DERIVED
PMID: 26573936 (View on PubMed)

Related Links

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Other Identifiers

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FoUS09001

Identifier Type: -

Identifier Source: org_study_id

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