AsthmaADEPTNCT00967720
Barriers to Adherence to Asthma Controller Meds in Low Income Urban Minority Adolescents
An observational study of Asthma, run by Rush University Medical Center.
Trial summary
Poor adherence to appropriate asthma medications is an important risk factor contributing to high asthma morbidity and mortality in urban African American adolescents. As part of the ADEPT (Adolescent Disease Empowerment and Persistency Technology) for Asthma Pilot 2 study, a focus group was developed specifically to… Read more about this study
- Who is it for?
- Ages 12 to 15 years
- Conditions the study is for
- Asthma
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Aug 2009
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Study population: four low income urban adolescents with uncontrolled moderate persistent asthma
Who may be able to join
- 12-18 years of age
- self identify as African American
- have persistent asthma
- read at a minimum fourth grade reading level
- be on a prescribed daily inhaled corticosteroid medication for asthma
Who cannot join
- candidate refusal or presence of other co-morbidities
About this study
Official title: Qualitative Analysis of the Barriers to Adherence With Asthma Controller Medication Among Inner City African American Adolescents as Identified Through Focus Group Data
Poor adherence to appropriate asthma medications is an important risk factor contributing to high asthma morbidity and mortality in urban African American adolescents. As part of the ADEPT (Adolescent Disease Empowerment and Persistency Technology) for Asthma Pilot 2 study, a focus group was developed specifically to explore existing barriers to adherence among inner city African American adolescent asthmatics.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Barriers, Adherence, Asthma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Focus groups explored whether a new communication medium improved adherence to asthma controller medications and to examine existing barriers to adherence among four urban African American adolescents with uncontrolled moderate persistent asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startMar 2008
- Primary completionAug 2009
- Study completionAug 2009
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 Rush University Medical CenterThe 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
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Giselle S Mosnaim, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967720
- Sponsor's protocol ID
- 08021601
- Acronym
- ADEPT
- Status last verified
- Nov 2017
- First submitted
- 26 Aug 2009
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Analysis of the Barriers to Adherence With Asthma Controller Medication Among Inner City African American Adolescents as Identified Through Focus Group Data
- ClinicalTrials.gov ID
- NCT00967720
- Acronym / sponsor ID
- ADEPT / 08021601
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 28 Aug 2009 (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.
Poor adherence to appropriate asthma medications is an important risk factor contributing to high asthma morbidity and mortality in urban African American adolescents. As part of the ADEPT (Adolescent Disease Empowerment and Persistency Technology) for Asthma Pilot 2 study, a focus group was developed specifically to explore existing barriers to adherence among inner city African American adolescent asthmatics.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Barriers, Adherence, Asthma | – | – |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- four low income urban adolescents with uncontrolled moderate persistent asthma
Key inclusion criteria (5 listed)
- 12-18 years of age
- self identify as African American
- have persistent asthma
- read at a minimum fourth grade reading level
- be on a prescribed daily inhaled corticosteroid medication for asthma
Key exclusion criteria (1 listed)
- candidate refusal or presence of other co-morbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Focus groups explored whether a new communication medium improved adherence to asthma controller medications and to examine existing barriers to adherence among four urban African American adolescents with uncontrolled moderate persistent asthma
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 Nov 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.
Giselle S Mosnaim, MD principal investigator
Rush University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Rush University Medical Center.
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 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Focus groups explored whether a new communication medium improved adherence to asthma controller medications and to examine existing barriers to adherence among four urban African American adolescents with uncontrolled moderate persistent asthma. 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 Nov 2017.