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临床试验/NCT00233233
NCT00233233已完成不适用

Assessment Mode and Validity of Self-Reports in Adults

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2002年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
139
试验地点
1
主要终点
Concordance between patient's self-reported medication adherence and electronically measured adherence

研究概览

简要总结

This study will examine how the assessment mode influences the validity of self-reported adherence to asthma therapy. Self-reported adherence to asthma therapy data will be collected using one of three randomized assessment modes (interview, computer, or telephone).

详细描述

BACKGROUND:

Self-reports are a primary source of behavioral data. Studies have highlighted the variable validity and reliability of self-report measures of health behaviors such as adherence to therapy. Research on self-reports of sensitive information, such as sexual behavior and drug use, suggests that the mode of data collection may enhance validity of self-reports. However, no studies have determined how the mode of data collection influences self-reports when an objective measure of the behavior is available.

DESIGN NARRATIVE:

The primary aim of this study is to examine the influence of the mode of data collection on the validity of self-reports of inhaled anti-inflammatory medication adherence.

The key secondary outcomes of the study will attempt to answer the following questions: 1) does the assessment mode influence self-reports of commonly used asthma outcome measures of disease-related symptoms, self-management behaviors, and quality of life?; 2) does the relationship between the assessment mode, the validity of self-reports of adherence, and other measures (i.e., asthma symptoms, self-management behaviors, and quality of life) change over time?; and 3) does the assessment mode interact with baseline personality characteristics and mood to influence the validity of self-reports of adherence and other outcome measures (i.e., asthma symptoms, self-management behaviors, and quality of life)?

研究设计

研究类型
Interventional
分配方式
Randomized

入排标准

年龄范围
19 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of asthma
  • •Under a provider's care for asthma
  • •Prescribed daily inhaled corticosteroids (by metered dose inhaler [MDI]) at least 2 times a day
  • •Speaks English
  • •Otherwise in good general health

排除标准

  • 未提供

结局指标

主要结局

Concordance between patient's self-reported medication adherence and electronically measured adherence

时间窗: Measured at Months 1 through 5

次要结局

  • Impact of mode of assessment on adult self-reports of asthma symptoms, asthma management practices, and quality of life(Measured at Months 1 through 5)
  • Relationship between baseline measures of psychosocial variables (i.e., personality and mood) and the primary outcome(Measured at Months 1 through 5)

研究者

发起方
Johns Hopkins University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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