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

Assessment Mode and Validity of Self-Reports in Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00233233
Enrollment
139
Registered
2005-10-05
Start date
2002-08-31
Completion date
2005-05-31
Last updated
2017-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Lung Diseases

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)?

Interventions

BEHAVIORALStandardized Asthma Education Program

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED

Eligibility

Sex/Gender
ALL
Age
19 Years to 95 Years
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

N/A

Design outcomes

Primary

MeasureTime frame
Concordance between patient's self-reported medication adherence and electronically measured adherenceMeasured at Months 1 through 5

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026