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

December 11, 2017 updated by: Johns Hopkins University

Assessment Mode and Validity of Self-Reports in Adults

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Behavioral: Standardized Asthma Education Program

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

Enrollment (Actual)

139

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Maryland
  - Baltimore, Maryland, United States, 21224
    - Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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:

N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Concordance between patient's self-reported medication adherence and electronically measured adherence Time Frame: Measured at Months 1 through 5	Measured at Months 1 through 5

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator: Cynthia Rand, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)