GotNet Study, The Gothenburg Nurse-led Tight Control Study
NCT ID: NCT02019901
Last Updated: 2017-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2014-01-31
2017-03-08
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Regular care
The control-group is treated according to "care as usual" with visits to physician every 6th month.
No interventions assigned to this group
Nurse-led clinic
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
Interventions
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Nurse-led clinic
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Göteborg University
OTHER
Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Ulrika Bergsten
RN, PHD
Principal Investigators
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Lennart Jacobsson, Professor
Role: PRINCIPAL_INVESTIGATOR
Göteborg University
Locations
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Sahlgrenska University Hospital
Gothenburg, , Sweden
Countries
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References
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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.
Other Identifiers
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GotNet 2014 SU
Identifier Type: -
Identifier Source: org_study_id
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