Clinical trial NCT00233233: Influence of Data Collection Mode on Self-Report Validity of Asthma Therapy Adherence
Official title: Assessment Mode and Validity of Self-Reports in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Diseases
Asthma
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-10-05
Enrollment: 139
Sex: ALL
Minimum age (years): 19
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED

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)?

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:

N/A

Primary outcomes:
measure: Concordance between patient's self-reported medication adherence and electronically measured adherence
timeFrame: Measured at Months 1 through 5
Secondary outcomes:
measure: Impact of mode of assessment on adult self-reports of asthma symptoms, asthma management practices, and quality of life
timeFrame: Measured at Months 1 through 5
measure: Relationship between baseline measures of psychosocial variables (i.e., personality and mood) and the primary outcome
timeFrame: Measured at Months 1 through 5
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Cynthia Rand, PhD
role: PRINCIPAL_INVESTIGATOR
References: