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

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ClinicalTrials.gov Identifier: NCT00233233
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University

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).

Condition or disease Intervention/treatment Phase
Lung Diseases Asthma Behavioral: Standardized Asthma Education Program Not Applicable

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)?


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Official Title: Assessment Mode and Validity of Self-Reports in Adults
Study Start Date : August 2002
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources




Primary Outcome Measures :
  1. Concordance between patient's self-reported medication adherence and electronically measured adherence [ Time Frame: Measured at Months 1 through 5 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Relationship between baseline measures of psychosocial variables (i.e., personality and mood) and the primary outcome [ Time Frame: Measured at Months 1 through 5 ]


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Ages Eligible for Study:   19 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233233


Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Cynthia Rand, PhD Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00233233     History of Changes
Other Study ID Numbers: 325
R01HL064200 ( U.S. NIH Grant/Contract )
First Posted: October 5, 2005    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

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