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Validation of a Tolerability Questionnaire in Rheumatoid Arthritis

2015年3月24日 更新者:Antonio D Gómez-Centeno、Corporacion Parc Tauli

Validation of a Specific Questionnaire to Assess the Tolerability of the Different Therapeutic Strategies in Rheumatoid Arthritis

The purpose of the present study is to assess the measurement properties of a tolerability questionnaire. The results obtained in patients with Rheumatoid Arthritis (RA) being treated will be robust and will assess the patient's tolerability to the treatment. Patients with greater tolerability will be more satisfied with their treatment.

研究概览

地位

未知

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

观察性的

注册 (预期的)

66

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Barcelona、西班牙、08036
        • 招聘中
        • Hospital Clínic
        • 接触:
          • Raimón Sanmartí
        • 首席研究员:
          • Raimón Sanmartí
      • Ibiza、西班牙、07800
        • 招聘中
        • Hospital Can Misses
        • 接触:
          • Ana Urruticoechea
        • 首席研究员:
          • Ana Urruticoechea
      • Mallorca、西班牙、07010
        • 招聘中
        • Hospital Son Espases
        • 接触:
          • Lluis Espadaler
        • 首席研究员:
          • Lluis Espadaler
      • Mallorca、西班牙、07198
        • 招聘中
        • Hospital Son Llatzer
        • 接触:
          • Inmaculada Ros
        • 首席研究员:
          • Inmaculada Ros
      • Sabadell、西班牙、08208
        • 招聘中
        • Hospital Corporacio Sanitaria Parc Tauli
        • 接触:
          • Antoni Gomez Centeno
        • 首席研究员:
          • Antoni Gomez Centeno
    • Barcelona
      • Sant Joan Despí、Barcelona、西班牙、08970
        • 招聘中
        • Hospital Moisés Broggi
        • 接触:
          • Hector Coromines
        • 首席研究员:
          • Hector Coromines

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

Patients diagnosed with Rheumatoid Arthritis

描述

Inclusion Criteria:

  1. Patients over 18 years old.
  2. Patients with RA diagnosed according to the standards of the ACR (American College of Rheumatology) in 1987 or to the ACR/EULAR in 2010
  3. Patients on treatment with any Rheumatoid Arthritis drug for at least 3 months before their inclusion in the study *
  4. 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:

  1. 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.
  2. 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.
  3. 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.
  4. Patients who participated in interviews of the Phase I (development of the questionnaire)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
single-group studies
Patients with RA diagnosed

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
To validate (evaluate measurement properties) a new questionnaire to measure the tolerability to the pharmacological treatment in RA patients in routine clinical practice
10 months

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
To assess the feasibility of the questionnaire by non-response rate and the time required to complete it
10 months
the construct validity of the questionnaire analyzing the relation between questionnaire scores and clinical data (discriminant validity).
大体时间:10 months
To assess the construct validity of the questionnaire analyzing the relation between questionnaire scores and clinical data (discriminant validity
10 months
the reliability of the questionnaire in terms of internal consistency
大体时间:10 months
To assess the reliability of the questionnaire in terms of internal consistency
10 months
describe socio-demographic and clinical features of the patients recruited in the study.
大体时间:10 months
To describe socio-demographic and clinical features of the patients recruited in the study.
10 months
the adverse reactions (AR) reported by patients impact in the daily life.
大体时间:10 months
To assess the adverse reactions (AR) reported by patients impact in the daily life
10 months
correlation between the tolerability questionnaire and the patient satisfaction
大体时间:10 months
To assess the correlation between the tolerability questionnaire and the patient satisfaction (ARTS questionnaire)
10 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Antoni Gomez Centeno、Hospital Corporacio Parc Tauli

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年1月1日

初级完成 (预期的)

2015年4月1日

研究完成 (预期的)

2015年12月1日

研究注册日期

首次提交

2015年3月19日

首先提交符合 QC 标准的

2015年3月24日

首次发布 (估计)

2015年3月30日

研究记录更新

最后更新发布 (估计)

2015年3月30日

上次提交的符合 QC 标准的更新

2015年3月24日

最后验证

2015年3月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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