Clinical trial NCT02019901: GotNet Study, The Gothenburg Nurse-led Tight Control Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Person-centered care
Tight control
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Göteborg University
First posted: 2013-12-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Disease activity score (DAS28)
timeFrame: Baseline, week 26 and 50
Secondary outcomes:
measure: Proportion of patients with low Disease activity score (DAS28)
timeFrame: Baseline, week 26 and 50
measure: Proportion of patients with remisson according to Disease activity score (DAS28)
timeFrame: Baseline, week 26 and 50
measure: Health assessment questionnaire (HAQ)
timeFrame: Baseline, week 26 and 50
measure: EuroQol (EQ-5D)
timeFrame: Baseline, week 26 and 50
measure: Visual analogue scale for pain (VAS-pain)
timeFrame: Baseline, week 26 and 50
measure: Visual analogue scale fatigue (VAS-Fatigue)
timeFrame: Baseline, week 26 and 50
measure: Visual analogue scale general health (VAS-general health)
timeFrame: Baseline, week 26 and 50
measure: Effective Consumer Survey 17 (EC17)
timeFrame: Baseline, week 26 and 50
measure: Rheumatoid Arthritis Impact of Disease (RAID) score,
timeFrame: Baseline, week 26 and 50
measure: The beliefs about medicines questionnaire (BMQ)
timeFrame: Baseline,week 26 and 50
measure: Numerical Rating Scale (NRS) about satisfaction with care
timeFrame: Baseline, week 26 and 50
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Göteborg University
name: Lennart Jacobsson, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bergsten U, Almehed K, Baigi A, Jacobsson LTH. A randomized study comparing regular care with a nurse-led clinic based on tight disease activity control and person-centred care in patients with rheumatoid arthritis with moderate/high disease activity: A 6-month evaluation. Musculoskeletal Care. 2019 Sep;17(3):215-225. doi: 10.1002/msc.1403. Epub 2019 Jun 20.