Validation of a Tolerability Questionnaire in Rheumatoid Arthritis
Validation of a Specific Questionnaire to Assess the Tolerability of the Different Therapeutic Strategies in Rheumatoid Arthritis
研究概览
地位
条件
详细说明
Clinicians do not have any standardized questionnaire to assess the tolerability from the patient's perspective. The tolerability assessment of the different pharmacological strategies for Rheumatoid Arthritis, from the patient's perspective, would provide additional information, improve doctor-patient communication and improve both adherence to and efficacy of treatment. For these reasons, the development and validation of a new tool is necessary not only for future researches, but for use in standard clinical practice.
The first phase of the development of the questionnaire has already been completed. The second phase of the development of the questionnaire has been designed at to validate the tool in the Spanish population.
This study aims to assess the measurement properties of a new tool which assesses the impact of daily life in Rheumatoid Arthritis.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Barcelona、西班牙、08036
- 招聘中
- Hospital Clínic
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接触:
- Raimón Sanmartí
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首席研究员:
- Raimón Sanmartí
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Ibiza、西班牙、07800
- 招聘中
- Hospital Can Misses
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接触:
- Ana Urruticoechea
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首席研究员:
- Ana Urruticoechea
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Mallorca、西班牙、07010
- 招聘中
- Hospital Son Espases
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接触:
- Lluis Espadaler
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首席研究员:
- Lluis Espadaler
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Mallorca、西班牙、07198
- 招聘中
- Hospital Son Llatzer
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接触:
- Inmaculada Ros
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首席研究员:
- Inmaculada Ros
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Sabadell、西班牙、08208
- 招聘中
- Hospital Corporacio Sanitaria Parc Tauli
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接触:
- Antoni Gomez Centeno
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首席研究员:
- Antoni Gomez Centeno
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Barcelona
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Sant Joan Despí、Barcelona、西班牙、08970
- 招聘中
- Hospital Moisés Broggi
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接触:
- Hector Coromines
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首席研究员:
- Hector Coromines
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients over 18 years old.
- Patients with RA diagnosed according to the standards of the ACR (American College of Rheumatology) in 1987 or to the ACR/EULAR in 2010
- Patients on treatment with any Rheumatoid Arthritis drug for at least 3 months before their inclusion in the study *
Patients who have provided informed consent prior to taking part in the study.
- It's not necessary for patients to be treated in first-line at the moment of the inclusion in the study.
Exclusion Criteria:
- Patients with rheumatic disease other than Rheumatoid Arthritis. Will be exclude patients with the following concomitant diseases: Rheumatic autoimmune disease other than RA; Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis; Diagnosis of juvenile idiopathic arthritis; inflammatory joint disease other than Rheumatoid Arthritis.
- Patients with any other concomitant disease or treatment that, under clinical criteria, could affect the results of the study or any major episode of infection or disease requiring hospitalization.
- Patients with any other medical or physiological condition that, in the view of the investigator, could compromise the ability of the patient to answer the study questions.
- Patients who participated in interviews of the Phase I (development of the questionnaire)
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:横截面
队列和干预
团体/队列 |
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single-group studies
Patients with RA diagnosed
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Validation of a new questionnaire to measure the tolerability to the pharmacological treatment in RA patients in patient's perspective.
大体时间:10 months
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To validate (evaluate measurement properties) a new questionnaire to measure the tolerability to the pharmacological treatment in RA patients in routine clinical practice
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10 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
the feasibility of the questionnaire by non-response rate and the time required to complete it
大体时间:10 months
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To assess the feasibility of the questionnaire by non-response rate and the time required to complete it
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10 months
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the construct validity of the questionnaire analyzing the relation between questionnaire scores and clinical data (discriminant validity).
大体时间:10 months
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To assess the construct validity of the questionnaire analyzing the relation between questionnaire scores and clinical data (discriminant validity
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10 months
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the reliability of the questionnaire in terms of internal consistency
大体时间:10 months
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To assess the reliability of the questionnaire in terms of internal consistency
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10 months
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describe socio-demographic and clinical features of the patients recruited in the study.
大体时间:10 months
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To describe socio-demographic and clinical features of the patients recruited in the study.
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10 months
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the adverse reactions (AR) reported by patients impact in the daily life.
大体时间:10 months
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To assess the adverse reactions (AR) reported by patients impact in the daily life
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10 months
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correlation between the tolerability questionnaire and the patient satisfaction
大体时间:10 months
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To assess the correlation between the tolerability questionnaire and the patient satisfaction (ARTS questionnaire)
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10 months
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合作者和调查者
调查人员
- 学习椅:Antoni Gomez Centeno、Hospital Corporacio Parc Tauli
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- FUN-TOC-2014-01
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