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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014