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

Study Overview
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Brief Summary
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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
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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)?

Official Title
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Assessment Mode and Validity of Self-Reports in Adults

Conditions
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Lung Diseases, Asthma

Intervention / Treatment
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* Behavioral: Standardized Asthma Education Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Standardized Asthma Education Program|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between patient's self-reported medication adherence and electronically measured adherence |  | Measured at Months 1 through 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |