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Clinical Trials/NCT00233233
NCT00233233
Completed
Not Applicable

Assessment Mode and Validity of Self-Reports in Adults

Johns Hopkins University1 site in 1 country139 target enrollmentAugust 2002

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Diseases
Sponsor
Johns Hopkins University
Enrollment
139
Locations
1
Primary Endpoint
Concordance between patient's self-reported medication adherence and electronically measured adherence
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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).

Detailed Description

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)?

Registry
clinicaltrials.gov
Start Date
August 2002
End Date
May 2005
Last Updated
8 years ago
Study Type
Interventional
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: Measured at Months 1 through 5

Secondary Outcomes

  • 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)

Study Sites (1)

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