Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

GotNet Study, The Gothenburg Nurse-led Tight Control Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02019901
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : May 19, 2017
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Ulrika Bergsten, Vastra Gotaland Region

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.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Other: Nurse-led clinic Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : March 8, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Regular care
The control-group is treated according to "care as usual" with visits to physician every 6th month.
Experimental: 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.
Other: Nurse-led clinic



Primary Outcome Measures :
  1. Change in Disease activity score (DAS28) [ Time Frame: Baseline, week 26 and 50 ]
    The primary outcome constitute of DAS28, an index comprising the number of tender and swollen joints, patients global health assessment and erythrocyte sedimentation rate


Secondary Outcome Measures :
  1. Proportion of patients with low Disease activity score (DAS28) [ Time Frame: Baseline, week 26 and 50 ]
  2. Proportion of patients with remisson according to Disease activity score (DAS28) [ Time Frame: Baseline, week 26 and 50 ]
  3. Health assessment questionnaire (HAQ) [ Time Frame: Baseline, week 26 and 50 ]
    Measures functional status

  4. EuroQol (EQ-5D) [ Time Frame: Baseline, week 26 and 50 ]
    Measures health status, allowing computation of cost-effectiveness

  5. Visual analogue scale for pain (VAS-pain) [ Time Frame: Baseline, week 26 and 50 ]
    Measures the patient's pain

  6. Visual analogue scale fatigue (VAS-Fatigue) [ Time Frame: Baseline, week 26 and 50 ]
    Measures the patient's fatigue.

  7. Visual analogue scale general health (VAS-general health) [ Time Frame: Baseline, week 26 and 50 ]
    Measures the patient's general health.

  8. Effective Consumer Survey 17 (EC17) [ Time Frame: Baseline, week 26 and 50 ]
    Measures patients' perception of their knowledge, attitudes and behaviors about self-management skills

  9. Rheumatoid Arthritis Impact of Disease (RAID) score, [ Time Frame: Baseline, week 26 and 50 ]
    A patient-derived composite measure of the impact of the disease

  10. The beliefs about medicines questionnaire (BMQ) [ Time Frame: Baseline,week 26 and 50 ]
    Assessing patients' perceptions and expectation about medicines

  11. Numerical Rating Scale (NRS) about satisfaction with care [ Time Frame: Baseline, week 26 and 50 ]
    Measures satisfaction with rheumatology care



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02019901


Locations
Layout table for location information
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden
Sponsors and Collaborators
Vastra Gotaland Region
Göteborg University
Investigators
Layout table for investigator information
Principal Investigator: Lennart Jacobsson, Professor Göteborg University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ulrika Bergsten, RN, PHD, Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT02019901    
Other Study ID Numbers: GotNet 2014 SU
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017
Keywords provided by Ulrika Bergsten, Vastra Gotaland Region:
Rheumatoid arthritis
Person-centered care
Tight control
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases