Skip to main content
OpenTrials
Completed

NCT Number: NCT02019901

GotNet Study, The Gothenburg Nurse-led Tight Control Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nurse-led clinic

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • Göteborg University

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Dec 24, 2013
Registry last updated
May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.