Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatment nurse-led clinic
Sponsor Vastra Gotaland Region
Collaborator Göteborg University
Start date January 2014
End date November 2016
Trial size 120 participants
Trial identifier NCT02019901, GotNet 2014 SU

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
The control-group is treated according to "care as usual" with visits to physician every 6th month.
(Experimental)
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.
nurse-led clinic

Primary Outcomes

Measure
Change in Disease activity score (DAS28)
time frame: Baseline, week 26 and 50

Secondary Outcomes

Measure
Proportion of patients with low Disease activity score (DAS28)
time frame: Baseline, week 26 and 50
Proportion of patients with remisson according to Disease activity score (DAS28)
time frame: Baseline, week 26 and 50
Health assessment questionnaire (HAQ)
time frame: Baseline, week 26 and 50
EuroQol (EQ-5D)
time frame: Baseline, week 26 and 50
Visual analogue scale for pain (VAS-pain)
time frame: Baseline, week 26 and 50
Visual analogue scale fatigue (VAS-Fatigue)
time frame: Baseline, week 26 and 50
Visual analogue scale general health (VAS-general health)
time frame: Baseline, week 26 and 50
Effective Consumer Survey 17 (EC17)
time frame: Baseline, week 26 and 50
Rheumatoid Arthritis Impact of Disease (RAID) score,
time frame: Baseline, week 26 and 50
The beliefs about medicines questionnaire (BMQ)
time frame: Baseline,week 26 and 50
Numerical Rating Scale (NRS) about satisfaction with care
time frame: Baseline, week 26 and 50

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

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
Principal investigator Lennart Jacobsson, Professor
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Vastra Gotaland Region.