Lung DiseasesNCT00233233
Influence of Data Collection Mode on Self-Report Validity of Asthma Therapy Adherence
A study testing Standardized Asthma Education Program in people with Lung Diseases and Asthma, run by Johns Hopkins University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 19 to 95 years
- Conditions the study is for
- Lung Diseases, Asthma
- What is being tested?
- Standardized Asthma Education Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to May 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
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)?
- Conditions
- Lung Diseases, Asthma
- Being tested
- Standardized Asthma Education Program
- Medical subject headings
- Lung Diseases, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Asthma Education ProgramBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between patient's self-reported medication adherence and electronically measured adherence
Measured: Measured at Months 1 through 5
Secondary outcomes (2)
Impact of mode of assessment on adult self-reports of asthma symptoms, asthma management practices, and quality of life
Measured: Measured at Months 1 through 5
Relationship between baseline measures of psychosocial variables (i.e., personality and mood) and the primary outcome
Measured: Measured at Months 1 through 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2005 (estimated)
- Study startAug 2002
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Cynthia Rand, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233233
- Sponsor's protocol ID
- 325
- Other IDs
- R01HL064200
- Status last verified
- Dec 2017
- First submitted
- 3 Oct 2005
- Last updated
- 13 Dec 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Mode and Validity of Self-Reports in Adults
- ClinicalTrials.gov ID
- NCT00233233
- Acronym / sponsor ID
- 325
- Conditions
- Lung Diseases, Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2002
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 5 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Allocation
- Randomised
Who may qualify
- Ages
- 19 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Asthma Education Program | Behavioural | – |
Primary outcome
Concordance between patient's self-reported medication adherence and electronically measured adherence
Time frame: Measured at Months 1 through 5
2 secondary outcomes
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
Relationship between baseline measures of psychosocial variables (i.e., personality and mood) and the primary outcome
Time frame: Measured at Months 1 through 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Rand, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Asthma Education Program in people with Lung Diseases and Asthma, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between patient's self-reported medication adherence and electronically measured adherence (time frame: Measured at Months 1 through 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017.