GotNet Study, The Gothenburg Nurse-led Tight Control Study

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT02019901
• Lead Sponsor: Vastra Gotaland Region

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-18
• Study First Submitted QC: 2013-12-18
• Study First Posted: 2013-12-24
• Study Start: 2014-01
• Primary Completion: 2016-11
• Study Completion: 2017-03-08
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-18
• Last Update Posted: 2017-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Disease activity score (DAS28)	Baseline, week 26 and 50	The primary outcome constitute of DAS28, an index comprising the number of tender and swollen joints, patients global health assessment and erythrocyte sedimentation rate

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with low Disease activity score (DAS28)	Baseline, week 26 and 50
Health assessment questionnaire (HAQ)	Baseline, week 26 and 50	Measures functional status
Visual analogue scale general health (VAS-general health)	Baseline, week 26 and 50	Measures the patient's general health.
Effective Consumer Survey 17 (EC17)	Baseline, week 26 and 50	Measures patients' perception of their knowledge, attitudes and behaviors about self-management skills
Rheumatoid Arthritis Impact of Disease (RAID) score,	Baseline, week 26 and 50	A patient-derived composite measure of the impact of the disease
The beliefs about medicines questionnaire (BMQ)	Baseline,week 26 and 50	Assessing patients' perceptions and expectation about medicines
Proportion of patients with remisson according to Disease activity score (DAS28)	Baseline, week 26 and 50
EuroQol (EQ-5D)	Baseline, week 26 and 50	Measures health status, allowing computation of cost-effectiveness
Visual analogue scale for pain (VAS-pain)	Baseline, week 26 and 50	Measures the patient's pain
Visual analogue scale fatigue (VAS-Fatigue)	Baseline, week 26 and 50	Measures the patient's fatigue.
Numerical Rating Scale (NRS) about satisfaction with care	Baseline, week 26 and 50	Measures satisfaction with rheumatology care

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden