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

Primary Purpose

Rheumatic Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Nurse-led clinic vs rheumatologist-led clinic
Sponsored by
Spenshult Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rheumatic Diseases focused on measuring Rheumatic diseases, Biologic treatment, Nurse-led

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Spenshult HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Rheumatologist-led clinic

Nurse-led clinic

Arm Description

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

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.

Outcomes

Primary Outcome Measures

DAS28 and costs for the clinics respectively.

Secondary Outcome Measures

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.

Full Information

First Posted
October 8, 2009
Last Updated
August 17, 2010
Sponsor
Spenshult Hospital
Collaborators
The Swedish Rheumatism Ass, County Council of Halland, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT01071447
Brief Title
Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment
Official Title
Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment:a Randomized Controlled Trial Comparing Nurse-led Clinic Versus Rheumatologist Clinic
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Spenshult Hospital
Collaborators
The Swedish Rheumatism Ass, County Council of Halland, Sweden

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Diseases
Keywords
Rheumatic diseases, Biologic treatment, Nurse-led

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rheumatologist-led clinic
Arm Type
Active Comparator
Arm Description
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
Arm Title
Nurse-led clinic
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Nurse-led clinic vs rheumatologist-led clinic
Other Intervention Name(s)
Nurse-led clinic, Rheumatologist-led clinic
Intervention Description
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.
Primary Outcome Measure Information:
Title
DAS28 and costs for the clinics respectively.
Time Frame
Baseline at 0 months, 6 months, 12 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Bergman, MD, PhD
Phone
+46-35 2635250
Email
stefan.bergman@spenshult.se
First Name & Middle Initial & Last Name or Official Title & Degree
Ingrid Larsson, RN, PhD-stud
Phone
+46-35 2635253
Email
ingrid.larsson@spenshult.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingrid Larsson, RN, PhD-stud
Organizational Affiliation
R&D-centre Spenshult
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefan Bergman, MD, PhD
Organizational Affiliation
R&D-centre Spenshult
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Barbro Arvidsson, RNT, prof
Organizational Affiliation
R&D-centre Spenshult
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bengt Fridlund, RNT, prof
Organizational Affiliation
University of Jönköping, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Spenshult Hospital
City
Oskarström
ZIP/Postal Code
S-31392
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Bergman, MD, PhD
Phone
+46-35 2635050
Email
stefan.bergman@spenshult.se
First Name & Middle Initial & Last Name & Degree
Ingrid Larsson, RN, PhD-stud
Phone
+46-35 2635253
Email
ingrid.larsson@spenshult.se
First Name & Middle Initial & Last Name & Degree
Ingrid Larsson, RN, PhD-stud

12. IPD Sharing Statement

Citations:
PubMed Identifier
26573936
Citation
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.
Results Reference
derived
Links:
URL
http://www.fou-spenshult.se
Description
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Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment

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