AsthmaNCT00399984
Evaluating a Pediatric Asthma Management Education Program for Physicians
A study testing Asthma Education Program in people with Asthma and Education, Medical, run by University of California, San Francisco at 1 site in United States.
Trial summary
Inhaled corticosteroids taken on a daily basis have been proven to be the most effective treatment for children with persistent asthma. However, many pediatricians still do not prescribe daily corticosteroids to their asthmatic patients; this can lead to poor health outcomes among asthmatic children. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma, Education, Medical
- What is being tested?
- Asthma Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Jun 2009
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pediatricians must meet all of the following criteria:
- Graduate of a pediatric residency program in the United States
- In active medical practice for at least 4 half-day sessions, with 40% clinical effort in general pediatrics
- At least 54 children with asthma in their patient population
- Parents of pediatric asthma patients must meet all of the following criteria:
- Parent or guardian of a pediatric patient that meets patient eligibility criteria
Show all 13Show fewer
- Able to identify that the participating physician is the child's primary care pediatrician
- Provides most asthma management or is the adult who normally takes the child to the doctor
- Pediatric patients must meet all of the following criteria:
- Older than 4 years of age (to decrease the likelihood that the child has bronchiolitis)
- Younger than 16 years of age (to ensure that during all 3 years of the evaluation part of the study, the child will be younger than 20 years of age)
- Diagnosis of asthma made by a physician using commonly accepted clinical criteria
- No other chronic disorders that have pulmonary complications (e.g., sickle cell disease, tuberculosis, acquired immune deficiency syndrome [AIDS], cystic fibrosis)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94118
About this study
Official title: Enhancing Pediatric Asthma Management
Inhaled corticosteroids taken on a daily basis have been proven to be the most effective treatment for children with persistent asthma. However, many pediatricians still do not prescribe daily corticosteroids to their asthmatic patients; this can lead to poor health outcomes among asthmatic children. This study will evaluate an interactive medical education program that focuses on improving pediatricians' asthma management skills and on encouraging increased corticosteroid use among their patients with asthma.
Read the detailed description
Asthma is a common childhood disease that affects over 9 million children in the United States. In 1997, the National Heart, Lung, and Blood Institute (NHLBI) published a set of guidelines aimed at improving the quality of patient care for individuals with asthma. According to the guidelines, a daily dose of inhaled corticosteroids is considered the most effective treatment for the long-term control of asthma. Despite this recommendation, many pediatricians are not prescribing daily corticosteroids to asthmatic children who may benefit from this treatment.
Continuing medical education (CME) is viewed as the primary method of keeping health care providers informed of new research knowledge and the latest medical trends. While traditional CME programs have not been successful in changing physician behavior, an interactive program that offers skills development for implementing changes in the care and treatment of asthmatic patients may prove effective. The purpose of this study is to develop, implement, and evaluate an interactive asthma education program targeted towards pediatricians. Specifically, the study will determine the program's effectiveness at developing asthma management skills in pediatricians, including corticosteroid prescribing practices, and improving asthma-related outcomes among their pediatric patients.
In this 5-year study, pediatricians will be randomly assigned to either an asthma education intervention group or a control group. The intervention group will attend the enhanced asthma education seminar, and the control group will attend a traditional lecture about asthma. In Years 1 and 2, the intervention group will participate in a 2-hour focus group to discuss barriers to adopting the NHLBI asthma guidelines for daily corticosteroid therapy. A brief survey on this same topic will also be completed. During Year 2, physicians in the intervention group will attend at least 5 hours of educational seminars designed to improve adherence to the recommended guidelines. In Years 2 through 5, all physicians will complete yearly questionnaires to assess barriers to corticosteroid prescription methods. Parents of asthmatic patients treated by the pediatricians will take part in a 20-minute telephone survey each year, and study researchers will review the medical records of each child.
- Conditions
- Asthma, Education, Medical
- Being tested
- Asthma Education Program
- Keywords
- Continuing Medical Education
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma Education ProgramBehavioural
interactive seminars regarding daily inhaled corticosteroids
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Asthma Education Program |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in physician knowledge, attitudes, and self-reported behavior
Measured: 1-3 years
Changes in patient asthma outcomes (both measured on a yearly basis)
Measured: 1-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2006 (estimated)
- Study startApr 2004
- Primary completionJun 2009
- Study completionJun 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 University of California, San FranciscoThe 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
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Michael D. Cabana, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399984
- Sponsor's protocol ID
- 437
- Other IDs
- R01HL070771
- Status last verified
- Jun 2013
- First submitted
- 13 Nov 2006
- Last updated
- 13 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Pediatric Asthma Management
- ClinicalTrials.gov ID
- NCT00399984
- Acronym / sponsor ID
- 437
- Conditions
- Asthma, Education, Medical
- Keywords
- Continuing Medical Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2004
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 15 Nov 2006 (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.
Inhaled corticosteroids taken on a daily basis have been proven to be the most effective treatment for children with persistent asthma. However, many pediatricians still do not prescribe daily corticosteroids to their asthmatic patients; this can lead to poor health outcomes among asthmatic children. This study will evaluate an interactive medical education program that focuses on improving pediatricians' asthma management skills and on encouraging increased corticosteroid use among their patients with asthma.
Detailed description
Asthma is a common childhood disease that affects over 9 million children in the United States. In 1997, the National Heart, Lung, and Blood Institute (NHLBI) published a set of guidelines aimed at improving the quality of patient care for individuals with asthma. According to the guidelines, a daily dose of inhaled corticosteroids is considered the most effective treatment for the long-term control of asthma. Despite this recommendation, many pediatricians are not prescribing daily corticosteroids to asthmatic children who may benefit from this treatment.
Continuing medical education (CME) is viewed as the primary method of keeping health care providers informed of new research knowledge and the latest medical trends. While traditional CME programs have not been successful in changing physician behavior, an interactive program that offers skills development for implementing changes in the care and treatment of asthmatic patients may prove effective. The purpose of this study is to develop, implement, and evaluate an interactive asthma education program targeted towards pediatricians. Specifically, the study will determine the program's effectiveness at developing asthma management skills in pediatricians, including corticosteroid prescribing practices, and improving asthma-related outcomes among their pediatric patients.
In this 5-year study, pediatricians will be randomly assigned to either an asthma education intervention group or a control group. The intervention group will attend the enhanced asthma education seminar, and the control group will attend a traditional lecture about asthma. In Years 1 and 2, the intervention group will participate in a 2-hour focus group to discuss barriers to adopting the NHLBI asthma guidelines for daily corticosteroid therapy. A brief survey on this same topic will also be completed. During Year 2, physicians in the intervention group will attend at least 5 hours of educational seminars designed to improve adherence to the recommended guidelines. In Years 2 through 5, all physicians will complete yearly questionnaires to assess barriers to corticosteroid prescription methods. Parents of asthmatic patients treated by the pediatricians will take part in a 20-minute telephone survey each year, and study researchers will review the medical records of each child.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Asthma Education Program |
| 2 | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Pediatricians must meet all of the following criteria:
- Parents of pediatric asthma patients must meet all of the following criteria:
- Pediatric patients must meet all of the following criteria:
Key exclusion criteria (0 listed)
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 Education Programinteractive seminars regarding daily inhaled corticosteroids | Behavioural | 1 |
Primary outcome
Changes in physician knowledge, attitudes, and self-reported behavior
Time frame: 1-3 years
Changes in patient asthma outcomes (both measured on a yearly basis)
Time frame: 1-3 years
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 Jun 2013.
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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.
Michael D. Cabana, MD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asthma Education Program in people with Asthma and Education, Medical, run by University of California, San Francisco 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 13 inclusion and 0 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 Jun 2013. 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?
Changes in physician knowledge, attitudes, and self-reported behavior (time frame: 1-3 years). The study lists 2 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 13 Jun 2013.