AsthmaNCT00140439
Improving Asthma Outcomes in an Urban Pediatric Population
A study testing Emergency Department based asthma follow-up clinic in people with Asthma, run by Stephen J. Teach, MD, MPH at 1 site in United States.
Trial summary
Little is known about how ED-based programs can help to reduce pediatric ED visits for asthma. The current study evaluated a novel intervention in which the ED itself became the site of highly individualized, comprehensive follow-up asthma care. Read more about this study
- Who is it for?
- Ages 12 months to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- Emergency Department based asthma follow-up clinic
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 488 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Jun 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 12 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age between 12 months and 17 years, inclusive;
- prior physician-diagnosed asthma;
- ≥1 other unscheduled visit for asthma in the previous 6 months and/or ≥1 hospitalization for asthma in the prior 12 months;
- a parent/guardian available for interview;
- residence in Washington, DC or a contiguous Maryland county; and
- requirement for ≥3 doses of nebulized albuterol in the ED at the time of enrollment.
Who cannot join
- significant medical co-morbidities affecting the cardiorespiratory system;
- a visit to an allergist or a pulmonologist in the prior 6 months;
- ≥2 of the following: a current written asthma medical action plan, current use of >1 controller medication, or a scheduled visit for asthma care with their PCP in the prior two weeks;
- enrollment in another asthma research study;
- unavailability for telephone follow-up; or
- primary language other than English or Spanish.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Improving Asthma Outcomes in a High Morbidity Urban Pediatric Population: an Emergency Department-based Randomized Clinical Trial
Little is known about how ED-based programs can help to reduce pediatric ED visits for asthma. The current study evaluated a novel intervention in which the ED itself became the site of highly individualized, comprehensive follow-up asthma care. It sought to determine if such an intervention could decrease subsequent unscheduled visits for asthma while improving asthma quality of life.
Read the detailed description
Prospective, randomized clinical trial of a single visit to a specialized emergency department-based asthma follow-up clinic occurring 2-15 days after emergency department care for an acute exacerbation. All patients were followed for 6 months. Analysis was by intention-to-treat with adjustment for baseline differences. Our primary hypothesis was that this intervention would decrease subsequent unscheduled visits (both to EDs and other sources of urgent care) for asthma over a six-month follow-up period. We further hypothesized that the intervention would decrease hospitalizations for asthma, improve compliance with an individualized medical plan and with trigger control, increase scheduled primary care practitioner (PCP) visits for routine asthma care, and decrease asthma symptoms while improving asthma quality of life (QOL).
- Conditions
- Asthma
- Being tested
- Emergency Department based asthma follow-up clinic
- Keywords
- asthma, emergency department, compliance, randomized clinical trial
- Medical subject headings
- Asthma, Emergencies, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency Department based asthma follow-up clinicBehavioural
The clinical activities of the intervention followed a fully specified protocol and provided education and care in three domains:
- Asthma self-monitoring and management: Educators first reviewed the basic physiology of asthma with emphasis on its chronicity. After evaluating asthma severity and treatment history, the physician completed an individualized medical action plan (MAP) and provided any necessary device teaching.
- Environmental modification and trigger control: After evaluation of potential environmental triggers in the home, each family was educated on their control. Each child was provided hypoallergenic bed encasings.
- Linkages and referrals to ongoing primary care: Clinic staff stressed the importance of longitudinal asthma care by a PCP. A full report of the clinic visit was mailed to each child's PCP. In addition, the asthma educator scheduled a follow-up appointment with the PCP within 4 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Unscheduled visits for asthma
Measured: 6 months following enrollment
Secondary outcomes (4)
Hospitalizations for asthma
Measured: 6 months following enrollment
Compliance
Measured: 6 months following enrollment
Quality of Life
Measured: 6 months following enrollment
Morbidity
Measured: 6 months following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startApr 2002
- Primary completionJun 2005
- Study completionJun 2005
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephen J. Teach, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Allergy, Asthma, and Immunology, Robert Wood Johnson Foundation
- Responsible party
- Sponsor-investigator, Stephen J. Teach, MD, MPH, Children's National Research Institute
- Investigators
- Stephen J Teach, MD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140439
- Sponsor's protocol ID
- RWJ EDDP
- Status last verified
- Aug 2015
- First submitted
- 31 Aug 2005
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Asthma Outcomes in a High Morbidity Urban Pediatric Population: an Emergency Department-based Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00140439
- Acronym / sponsor ID
- RWJ EDDP
- Conditions
- Asthma
- Keywords
- asthma, emergency department, compliance, randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- Stephen J. Teach, MD, MPHUniversity, hospital or other
- Collaborators
- American Academy of Allergy, Asthma, and Immunology, Robert Wood Johnson Foundation
- Study start
- Apr 2002
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 1 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.
Little is known about how ED-based programs can help to reduce pediatric ED visits for asthma. The current study evaluated a novel intervention in which the ED itself became the site of highly individualized, comprehensive follow-up asthma care. It sought to determine if such an intervention could decrease subsequent unscheduled visits for asthma while improving asthma quality of life.
Detailed description
Prospective, randomized clinical trial of a single visit to a specialized emergency department-based asthma follow-up clinic occurring 2-15 days after emergency department care for an acute exacerbation. All patients were followed for 6 months. Analysis was by intention-to-treat with adjustment for baseline differences. Our primary hypothesis was that this intervention would decrease subsequent unscheduled visits (both to EDs and other sources of urgent care) for asthma over a six-month follow-up period. We further hypothesized that the intervention would decrease hospitalizations for asthma, improve compliance with an individualized medical plan and with trigger control, increase scheduled primary care practitioner (PCP) visits for routine asthma care, and decrease asthma symptoms while improving asthma quality of life (QOL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 12 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- age between 12 months and 17 years, inclusive;
- prior physician-diagnosed asthma;
- ≥1 other unscheduled visit for asthma in the previous 6 months and/or ≥1 hospitalization for asthma in the prior 12 months;
- a parent/guardian available for interview;
- residence in Washington, DC or a contiguous Maryland county; and
Key exclusion criteria (6 listed)
- significant medical co-morbidities affecting the cardiorespiratory system;
- a visit to an allergist or a pulmonologist in the prior 6 months;
- ≥2 of the following: a current written asthma medical action plan, current use of >1 controller medication, or a scheduled visit for asthma care with their PCP in the prior two weeks;
- enrollment in another asthma research study;
- unavailability for telephone follow-up; or
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 |
|---|---|---|
| Emergency Department based asthma follow-up clinicThe clinical activities of the intervention followed a fully specified protocol and provided education and care in three domains: 1. Asthma self-monitoring and management: Educators first reviewed the basic physiology of asthma with emphasis on its chronicity. After evaluating asthma severity and treatment history, the physician completed an individualized medical action plan (MAP) and provided any necessary device teaching. 2. Environmental modification and trigger control: After evaluation of potential environmental triggers in the home, each family was educated on their control. Each child was provided hypoallergenic bed encasings. 3. Linkages and referrals to ongoing primary care: Clinic staff stressed the importance of longitudinal asthma care by a PCP. A full report of the clinic visit was mailed to each child's PCP. In addition, the asthma educator scheduled a follow-up appointment with the PCP within 4 weeks | Behavioural | – |
Primary outcome
Unscheduled visits for asthma
Time frame: 6 months following enrollment
4 secondary outcomes
Hospitalizations for asthma
Time frame: 6 months following enrollment
Compliance
Time frame: 6 months following enrollment
Quality of Life
Time frame: 6 months following enrollment
Morbidity
Time frame: 6 months following enrollment
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 25 Aug 2015.
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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.
Stephen J Teach, MD principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emergency Department based asthma follow-up clinic in people with Asthma, run by Stephen J. Teach, MD, MPH 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 6 inclusion and 6 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 25 Aug 2015. 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?
Unscheduled visits for asthma (time frame: 6 months following enrollment). 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 25 Aug 2015.