Influence of Data Collection Mode on Self-Report Validity of Asthma Therapy Adherence

Not Applicable

Completed

• Conditions: Asthma; Lung Diseases

• Registration Number: NCT00233233
• Lead Sponsor: Johns Hopkins University

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)?

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2005-05
• Study Completion: 2005-05
• Study First Submitted: 2005-10-03
• Study First Submitted QC: 2005-10-03
• Study First Posted: 2005-10-05
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-11
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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

N/A

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concordance between patient's self-reported medication adherence and electronically measured adherence	Measured at Months 1 through 5

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States