GotNet Study, The Gothenburg Nurse-led Tight Control Study

Vastra Gotaland Region

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Other: Nurse-led clinic

Study type: Interventional

Funder types: Other

Identifiers

NCT02019901

GotNet 2014 SU

Details and patient eligibility

About

Purpose: To compare a nurse-led clinic including person-centered care and tight control with "care as usual" in patients with rheumatoid arthritis (RA) and moderate/ high disease activity.

Project description: Study population: Patients with RA, 18-80 yrs old, with moderate/ high Disease Activity Score of 28 joints (DAS28 > 3.8) and disease duration > 2 yrs in a 6-month randomized controlled study with a 6 month open follow-up. Intervention group (N=60): Nurse-led visits every 6th week, with structured person-centered care and evaluation of disease activity. If disease remission is not reached, pharmacological treatment including both short-term (intra-articular and oral steroids) and long-term alterations (DMARDs and biologics) is modified according to a predefined algorithm. The control group (N=60) is treated according to "care as usual" with visits to physician every 6th month. Outcome measures: Primary outcome measure is change in Diseases Activity Score (DAS). Secondary outcomes are quality of life, self-efficacy, disability, emotional well-being, pain, fatigue, sleep and satisfaction.

Enrollment: 70 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 and <80 years of age
• Signed and dated informed consent form before the start of any specific protocol procedures
• Fulfill the 1987 ACR criteria or the 2010 ACR/EULAR criteria for RA with disease duration of >2 years
• Moderate to high disease activity (DAS28 >3.8)
• ≥2 swollen joints

Exclusion criteria

• Diagnosis of any other inflammatory arthritis
• History of chronic infection, recent serious or life-threatening infection within 6 months
• Concurrent malignancy, a history of malignancy or current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Regular care

No Intervention group

Description:

The control-group is treated according to "care as usual" with visits to physician every 6th month.

Nurse-led clinic

Experimental group

Description:

Nurse-led visits every 6th week, with structured person-centered care and evaluation of disease activity. If disease remission is not reached, pharmacological treatment including both short-term (intra-articular and oral steroids) and long-term alterations (DMARDs and biologics) is modified according to a predefined algorithm.

Treatment:

Other: Nurse-led clinic