AsthmaNCT00181194
Reducing Asthma Disparities by Improving Provider-Patient Communication
An observational study of Asthma, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study will be to assess the impact of a culturally-sensitive, patient-focused asthma communication instrument (ACCI) designed to enhance provider-patient communication by prompting and guiding providers in assessments of disease severity and discussion of adherence behaviors with minority patients… Read more about this study
- Who is it for?
- Ages 12 to 85 years
- Conditions the study is for
- Asthma
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Dec 2012
- Phase
- Observational
- 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 12 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- are able to provide informed consent;
- report physician-diagnosed asthma;
- report asthma symptoms and/or use of short-acting reliever medication at least twice weekly in the past month.
Who cannot join
- state they do not have asthma;
- have mild intermittent disease
- no recent evidence of disease activity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Asthma And Allergy Center
Baltimore, Maryland, 21224
About this study
Official title: Reducing Asthma Disparities by Improving Provider-Patient Communication About Asthma Severity and Adherence With Therapy
The purpose of this study will be to assess the impact of a culturally-sensitive, patient-focused asthma communication instrument (ACCI) designed to enhance provider-patient communication by prompting and guiding providers in assessments of disease severity and discussion of adherence behaviors with minority patients with asthma.
Read the detailed description
Improving communication between health care providers and their patients is the critical first step in efforts designed to reduce asthma-related health disparities in urban areas. Improving communication will help providers tailor asthma therapies to their patients' needs, and help providers and patients to overcome barriers (e.g., concerns about adverse effects) to adherence with those asthma treatment plans.
- Conditions
- Asthma
- Being tested
- Asthma Control and Communication Instrument
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma Control and Communication InstrumentDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Provider Assessment of Asthma Severity
Accuracy of Clinician Assessment of Patient Adherence
Assessment of appropriateness of asthma treatment (consistency of care with asthma guidelines
Patient satisfaction with provider-patient communication and medical care
Secondary outcomes (1)
These outcomes include indicators of poor asthma control such as health care service use for asthma exacerbations (unscheduled office visits, ER visits, hospitalizations) and use of oral corticosteroid and overuse of inhaled beta-agonist medications.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionDec 2006
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Observational
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Gregory B Diette, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181194
- Sponsor's protocol ID
- 20021855
- Status last verified
- Aug 2018
- First submitted
- 13 Sep 2005
- Last updated
- 21 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Asthma Disparities by Improving Provider-Patient Communication About Asthma Severity and Adherence With Therapy
- ClinicalTrials.gov ID
- NCT00181194
- Acronym / sponsor ID
- 20021855
- Conditions
- Asthma
- Keywords
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- May 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Sep 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.
The purpose of this study will be to assess the impact of a culturally-sensitive, patient-focused asthma communication instrument (ACCI) designed to enhance provider-patient communication by prompting and guiding providers in assessments of disease severity and discussion of adherence behaviors with minority patients with asthma.
Detailed description
Improving communication between health care providers and their patients is the critical first step in efforts designed to reduce asthma-related health disparities in urban areas. Improving communication will help providers tailor asthma therapies to their patients' needs, and help providers and patients to overcome barriers (e.g., concerns about adverse effects) to adherence with those asthma treatment plans.
Study design
Who may qualify
- Ages
- 12 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- are able to provide informed consent;
- report physician-diagnosed asthma;
- report asthma symptoms and/or use of short-acting reliever medication at least twice weekly in the past month.
Key exclusion criteria (3 listed)
- state they do not have asthma;
- have mild intermittent disease
- no recent evidence of disease activity.
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 |
|---|---|---|
| Asthma Control and Communication Instrument | Device | – |
Primary outcome
Accuracy of Provider Assessment of Asthma Severity
Accuracy of Clinician Assessment of Patient Adherence
Assessment of appropriateness of asthma treatment (consistency of care with asthma guidelines
Patient satisfaction with provider-patient communication and medical care
1 secondary outcome
These outcomes include indicators of poor asthma control such as health care service use for asthma exacerbations (unscheduled office visits, ER visits, hospitalizations) and use of oral corticosteroid and overuse of inhaled beta-agonist medications.
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 21 Aug 2018.
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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.
Gregory B Diette, MD, MHS 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?
An observational study of 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 3 inclusion and 3 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 21 Aug 2018. 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?
Accuracy of Provider Assessment of Asthma Severity. The study lists 4 primary outcomes in all. 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 21 Aug 2018.