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- Ensayo clínico NCT02019901
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
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.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Gothenburg, Suecia
- Sahlgrenska University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Sin intervención: Regular care
The control-group is treated according to "care as usual" with visits to physician every 6th month.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Disease activity score (DAS28)
Periodo de tiempo: Baseline, week 26 and 50
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The primary outcome constitute of DAS28, an index comprising the number of tender and swollen joints, patients global health assessment and erythrocyte sedimentation rate
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Baseline, week 26 and 50
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Proportion of patients with low Disease activity score (DAS28)
Periodo de tiempo: Baseline, week 26 and 50
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Baseline, week 26 and 50
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Proportion of patients with remisson according to Disease activity score (DAS28)
Periodo de tiempo: Baseline, week 26 and 50
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Baseline, week 26 and 50
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Health assessment questionnaire (HAQ)
Periodo de tiempo: Baseline, week 26 and 50
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Measures functional status
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Baseline, week 26 and 50
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EuroQol (EQ-5D)
Periodo de tiempo: Baseline, week 26 and 50
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Measures health status, allowing computation of cost-effectiveness
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Baseline, week 26 and 50
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Visual analogue scale for pain (VAS-pain)
Periodo de tiempo: Baseline, week 26 and 50
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Measures the patient's pain
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Baseline, week 26 and 50
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Visual analogue scale fatigue (VAS-Fatigue)
Periodo de tiempo: Baseline, week 26 and 50
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Measures the patient's fatigue.
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Baseline, week 26 and 50
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Visual analogue scale general health (VAS-general health)
Periodo de tiempo: Baseline, week 26 and 50
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Measures the patient's general health.
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Baseline, week 26 and 50
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Effective Consumer Survey 17 (EC17)
Periodo de tiempo: Baseline, week 26 and 50
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Measures patients' perception of their knowledge, attitudes and behaviors about self-management skills
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Baseline, week 26 and 50
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Rheumatoid Arthritis Impact of Disease (RAID) score,
Periodo de tiempo: Baseline, week 26 and 50
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A patient-derived composite measure of the impact of the disease
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Baseline, week 26 and 50
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The beliefs about medicines questionnaire (BMQ)
Periodo de tiempo: Baseline,week 26 and 50
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Assessing patients' perceptions and expectation about medicines
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Baseline,week 26 and 50
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Numerical Rating Scale (NRS) about satisfaction with care
Periodo de tiempo: Baseline, week 26 and 50
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Measures satisfaction with rheumatology care
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Baseline, week 26 and 50
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Lennart Jacobsson, Professor, Göteborg University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GotNet 2014 SU
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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