Assessment Mode and Validity of Self-Reports in Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 139
- Locations
- 1
- Primary Endpoint
- Concordance between patient's self-reported medication adherence and electronically measured adherence
Study 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)?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
Eligibility Criteria
- Ages
- 19 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)