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

Asthma Clinical Trial

Official title:

Assessment Mode and Validity of Self-Reports in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233233
• Other study ID #: 325
• Secondary ID: R01HL064200
• Status: Completed
• Phase: N/A
• First received: October 3, 2005
• Last updated: December 11, 2017
• Start date: August 2002
• Est. completion date: May 2005

Study information

• Verified date: December 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 95 Years

Eligibility

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:

Related Conditions & MeSH terms

• Asthma
• Lung Diseases

Intervention

Behavioral:
• Standardized Asthma Education Program

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance between patient's self-reported medication adherence and electronically measured adherence		Measured at Months 1 through 5
Secondary	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
Secondary	Relationship between baseline measures of psychosocial variables (i.e., personality and mood) and the primary outcome		Measured at Months 1 through 5