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

August 17, 2010 updated by: Spenshult Hospital

Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment:a Randomized Controlled Trial Comparing Nurse-led Clinic Versus Rheumatologist Clinic

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Oskarström, Sweden, S-31392
        • Recruiting
        • Spenshult Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ingrid Larsson, RN, PhD-stud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Other: 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.
Other Names:
  • Nurse-led clinic
  • Rheumatologist-led clinic
Experimental: 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.
Other: 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.
Other Names:
  • Nurse-led clinic
  • Rheumatologist-led clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
DAS28 and costs for the clinics respectively.
Time Frame: Baseline at 0 months, 6 months, 12 months
Baseline at 0 months, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Baseline at 0 months, 6 months, 12 months
Baseline at 0 months, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spenshult Hospital

Collaborators

The Swedish Rheumatism Ass
County Council of Halland, Sweden

Investigators

  • Study Director: Stefan Bergman, MD, PhD, R&D-centre Spenshult
  • Principal Investigator: Ingrid Larsson, RN, PhD-stud, R&D-centre Spenshult
  • Study Chair: Barbro Arvidsson, RNT, prof, R&D-centre Spenshult
  • Study Chair: Bengt Fridlund, RNT, prof, University of Jönköping, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Anticipated)

October 1, 2012

Study Registration Dates

First Submitted

October 8, 2009

First Submitted That Met QC Criteria

February 18, 2010

First Posted (Estimate)

February 19, 2010

Study Record Updates

Last Update Posted (Estimate)

August 18, 2010

Last Update Submitted That Met QC Criteria

August 17, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FoUS09001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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