Influence of Data Collection Mode on Self-Report Validity of Asthma Therapy Adherence
NCT ID: NCT00233233
Last Updated: 2017-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
139 participants
INTERVENTIONAL
2002-08-31
2005-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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)?
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Standardized Asthma Education Program
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
19 Years
95 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Johns Hopkins University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cynthia Rand, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Johns Hopkins University
Baltimore, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
325
Identifier Type: -
Identifier Source: org_study_id