GotNet Study, The Gothenburg Nurse-led Tight Control Study

May 18, 2017 updated by: Ulrika Bergsten, Vastra Gotaland Region

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, week 26 and 50

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with low Disease activity score (DAS28)
Time Frame: Baseline, week 26 and 50
Baseline, week 26 and 50
Proportion of patients with remisson according to Disease activity score (DAS28)
Time Frame: Baseline, week 26 and 50
Baseline, week 26 and 50
Health assessment questionnaire (HAQ)
Time Frame: Baseline, week 26 and 50
Measures functional status
Baseline, week 26 and 50
EuroQol (EQ-5D)
Time Frame: Baseline, week 26 and 50
Measures health status, allowing computation of cost-effectiveness
Baseline, week 26 and 50
Visual analogue scale for pain (VAS-pain)
Time Frame: Baseline, week 26 and 50
Measures the patient's pain
Baseline, week 26 and 50
Visual analogue scale fatigue (VAS-Fatigue)
Time Frame: Baseline, week 26 and 50
Measures the patient's fatigue.
Baseline, week 26 and 50
Visual analogue scale general health (VAS-general health)
Time Frame: Baseline, week 26 and 50
Measures the patient's general health.
Baseline, week 26 and 50
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
Baseline, week 26 and 50
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
Baseline, week 26 and 50
The beliefs about medicines questionnaire (BMQ)
Time Frame: Baseline,week 26 and 50
Assessing patients' perceptions and expectation about medicines
Baseline,week 26 and 50
Numerical Rating Scale (NRS) about satisfaction with care
Time Frame: Baseline, week 26 and 50
Measures satisfaction with rheumatology care
Baseline, week 26 and 50

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Collaborators

Göteborg University

Investigators

  • Principal Investigator: Lennart Jacobsson, Professor, Göteborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

March 8, 2017

Study Registration Dates

First Submitted

December 18, 2013

First Submitted That Met QC Criteria

December 18, 2013

First Posted (Estimate)

December 24, 2013

Study Record Updates

Last Update Posted (Actual)

May 19, 2017

Last Update Submitted That Met QC Criteria

May 18, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GotNet 2014 SU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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