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

Rheumatic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01071447
• Other study ID #: FoUS09001
• Status: Recruiting
• Phase: N/A
• First received: October 8, 2009
• Last updated: August 17, 2010
• Start date: October 2009
• Est. completion date: October 2012

Study information

• Verified date: August 2010
• Source: Spenshult Hospital
• Contact: Stefan Bergman, MD, PhD
• Phone: +46-35 2635250
• Email: stefan.bergman[@]spenshult.se
• Is FDA regulated: No
• Health authority: Sweden: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Rheumatic Diseases

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.

Locations

Country	Name	City	State
Sweden	Spenshult Hospital	Oskarström

Sponsors (3)

Lead Sponsor	Collaborator
Spenshult Hospital	County Council of Halland, Sweden, The Swedish Rheumatism Ass

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DAS28 and costs for the clinics respectively.		Baseline at 0 months, 6 months, 12 months	No
Secondary	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	No

External Links

•   Link