GotNet Study, The Gothenburg Nurse-led Tight Control Study

Rheumatoid Arthritis Clinical Trial

Official title:

A Randomized, Controlled Study Evaluating the Efficacy of Person-centered, Tight Control Nurse-led Clinic of Patients With Established Rheumatoid Arthritis and Moderate to High Disease Activity Compared to Patients Receiving Regular Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02019901
• Other study ID #: GotNet 2014 SU
• Status: Completed
• Phase: N/A
• First received: December 18, 2013
• Last updated: May 18, 2017
• Start date: January 2014
• Est. completion date: March 8, 2017

Study information

• Verified date: May 2017
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 8, 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Nurse-led clinic

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Vastra Gotaland Region	Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Disease activity score (DAS28)	The primary outcome constitute of DAS28, an index comprising the number of tender and swollen joints, patients global health assessment and erythrocyte sedimentation rate	Baseline, week 26 and 50
Secondary	Proportion of patients with low Disease activity score (DAS28)		Baseline, week 26 and 50
Secondary	Proportion of patients with remisson according to Disease activity score (DAS28)		Baseline, week 26 and 50
Secondary	Health assessment questionnaire (HAQ)	Measures functional status	Baseline, week 26 and 50
Secondary	EuroQol (EQ-5D)	Measures health status, allowing computation of cost-effectiveness	Baseline, week 26 and 50
Secondary	Visual analogue scale for pain (VAS-pain)	Measures the patient's pain	Baseline, week 26 and 50
Secondary	Visual analogue scale fatigue (VAS-Fatigue)	Measures the patient's fatigue.	Baseline, week 26 and 50
Secondary	Visual analogue scale general health (VAS-general health)	Measures the patient's general health.	Baseline, week 26 and 50
Secondary	Effective Consumer Survey 17 (EC17)	Measures patients' perception of their knowledge, attitudes and behaviors about self-management skills	Baseline, week 26 and 50
Secondary	Rheumatoid Arthritis Impact of Disease (RAID) score,	A patient-derived composite measure of the impact of the disease	Baseline, week 26 and 50
Secondary	The beliefs about medicines questionnaire (BMQ)	Assessing patients' perceptions and expectation about medicines	Baseline,week 26 and 50
Secondary	Numerical Rating Scale (NRS) about satisfaction with care	Measures satisfaction with rheumatology care	Baseline, week 26 and 50