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

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00233233
First received: October 3, 2005
Last updated: October 7, 2008
Last verified: October 2008
  Purpose

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).


Condition Intervention
Lung Diseases
Asthma
Behavioral: Standardized Asthma Education Program

Study Type: Interventional
Study Design: Allocation: Randomized
Official Title: Assessment Mode and Validity of Self-Reports in Adults

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Concordance between patient's self-reported medication adherence and electronically measured adherence [ Time Frame: Measured at Months 1 through 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impact of mode of assessment on adult self-reports of asthma symptoms, asthma management practices, and quality of life [ Time Frame: Measured at Months 1 through 5 ] [ Designated as safety issue: No ]
  • Relationship between baseline measures of psychosocial variables (i.e., personality and mood) and the primary outcome [ Time Frame: Measured at Months 1 through 5 ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: August 2002
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   19 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00233233

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Investigators
Principal Investigator: Cynthia Rand, PhD Johns Hopkins University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00233233     History of Changes
Other Study ID Numbers: 325, R01 HL064200
Study First Received: October 3, 2005
Last Updated: October 7, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Asthma
Lung Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014