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CompletedNCT00233233Updated Dec 13, 2017

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

An interventional study of Standardized Asthma Education Program in Lung Diseases and Asthma, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 19 Years to 95 Years. Per ClinicalTrials.gov, last updated 2017-12-13.

Sponsored by Johns Hopkins University · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
139
Allocation
Randomized
Ages
19 Years to 95 Years
Sex
All
01

Study 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).

Read the 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)?

02

Conditions studied

  • Lung Diseases
  • Asthma
03

In context

Lung Diseases

3,319 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 139 is above the median of 71 across 2,122 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,809 studies on the registry; 314 are open to participants now.

Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

N/A

05

Study design

Phase
Not applicable
Allocation
Randomized
Enrollment
139 participants (actual)

Interventions

  • BehavioralStandardized Asthma Education Program
06

What researchers measure

Primary outcomes

  1. Concordance between patient's self-reported medication adherence and electronically measured adherence

    Time frame: Measured at Months 1 through 5

Secondary outcomes

  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

07

Study locations

1 site
  • Johns Hopkins University
    Baltimore, Maryland 21224, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2002, a primary completion of May 2005 and a completion of May 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 3, 2005
First posted
Oct 5, 2005
Start
Aug 2002
Primary completionActual
May 2005
CompletionActual
May 2005
Last update
Dec 13, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00233233
Responsible party
Sponsor
First posted
Oct 5, 2005
Start date
Aug 2002
Primary completion
May 2005
Completion
May 2005
Last update
Dec 13, 2017

Study contacts

Cynthia Rand, PhD
principal investigator · Johns Hopkins University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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