NCT01071447

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2009

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

August 18, 2010

Status Verified

August 1, 2010

Enrollment Period

2 years

First QC Date

October 8, 2009

Last Update Submit

August 17, 2010

Conditions

Rheumatic Diseases

Keywords

Rheumatic diseasesBiologic treatmentNurse-led

Outcome Measures

Primary Outcomes (1)

  • DAS28 and costs for the clinics respectively.

    Baseline at 0 months, 6 months, 12 months

Secondary Outcomes (1)

  • 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.

    Baseline at 0 months, 6 months, 12 months

Study Arms (2)

Rheumatologist-led clinic

ACTIVE COMPARATOR

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

Nurse-led clinic

EXPERIMENTAL

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

Interventions

Nurse-led clinic vs rheumatologist-led clinicOTHER

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.

Also known as: Nurse-led clinic, Rheumatologist-led clinic
Nurse-led clinicRheumatologist-led clinic

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spenshult Hospital

Oskarström, Oskarström, S-31392, Sweden

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26573936DERIVED

Related Links

MeSH Terms

Conditions

Rheumatic Diseases

Interventions

Practice Patterns, Nurses'

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Ingrid Larsson, RN, PhD-stud

    R&D-centre Spenshult

    PRINCIPAL INVESTIGATOR

  • Stefan Bergman, MD, PhD

    R&D-centre Spenshult

    STUDY DIRECTOR

  • Barbro Arvidsson, RNT, prof

    R&D-centre Spenshult

    STUDY CHAIR

  • Bengt Fridlund, RNT, prof

    University of Jönköping, Sweden

    STUDY CHAIR

Central Study Contacts

Stefan Bergman, MD, PhD

CONTACT

+46-35 2635250stefan.bergman@spenshult.se

Ingrid Larsson, RN, PhD-stud

CONTACT

+46-35 2635253ingrid.larsson@spenshult.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 8, 2009

First Posted

February 19, 2010

Study Start

October 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2012

Last Updated

August 18, 2010

Record last verified: 2010-08

Locations

SE(1)