GotNet Study, The Gothenburg Nurse-led Tight Control Study
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
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable rheumatoid-arthritis
Started Jan 2014
Typical duration for not_applicable rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2013
CompletedFirst Posted
Study publicly available on registry
December 24, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2017
CompletedMay 19, 2017
May 1, 2017
2.8 years
December 18, 2013
May 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Proportion of patients with low Disease activity score (DAS28)
Baseline, week 26 and 50
Proportion of patients with remisson according to Disease activity score (DAS28)
Baseline, week 26 and 50
Health assessment questionnaire (HAQ)
Baseline, week 26 and 50
EuroQol (EQ-5D)
Baseline, week 26 and 50
Visual analogue scale for pain (VAS-pain)
Baseline, week 26 and 50
- +6 more secondary outcomes
Study Arms (2)
Regular care
NO INTERVENTIONThe control-group is treated according to "care as usual" with visits to physician every 6th month.
Nurse-led clinic
EXPERIMENTALNurse-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.
Interventions
Eligibility Criteria
You may qualify if:
- ≥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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vastra Gotaland Regionlead
- Göteborg Universitycollaborator
Study Sites (1)
Sahlgrenska University Hospital
Gothenburg, Sweden
Related Publications (1)
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.
PMID: 31219668DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lennart Jacobsson, Professor
Göteborg University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- RN, PHD
Study Record Dates
First Submitted
December 18, 2013
First Posted
December 24, 2013
Study Start
January 1, 2014
Primary Completion
November 1, 2016
Study Completion
March 8, 2017
Last Updated
May 19, 2017
Record last verified: 2017-05