AsthmaPhase 4Asthma APGARNCT01446315
Assessing Decision Maker Tools for Asthma: the Asthma APGAR
A Phase 4 study testing Use of Asthma APGAR system and tools and Asthma APGAR tools in people with Asthma, run by Olmsted Medical Center at 1 site in United States.
Trial summary
Asthma is a common problem among US adults and children. Unfortunately many people with asthma continue to suffer from asthma symptoms that could be control with better asthma care and more attention to details such as triggers, and adherence. Read more about this study
- Who is it for?
- Ages 5 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- Use of Asthma APGAR system and tools and Asthma APGAR tools
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Oct 2014
- Phase
- Phase 4
- 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 5 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Have physician diagnosed asthma
- Male or female between ages 5 through 60 years
- Have persistent asthma as assessed by daily use of "controller" medication
- Receive continuity care at practice where enrolled.
- Not have been in ICU for asthma ever
- Do not require daily or every other day oral steroids for asthma control
Who cannot join
- Cannot read and speak English
- Child refuses assent
Trial locations and contacts
1 site in 1 country.
About this study
Asthma is a common problem among US adults and children. Unfortunately many people with asthma continue to suffer from asthma symptoms that could be control with better asthma care and more attention to details such as triggers, and adherence. To date the only tools available and recommended by groups such as the national asthma guideline group consider only asthma burden and do not include information on the most common factors that adversely affect asthma control. This study provides one half of the enrolled primary care offices with the Asthma APGAR which is a system of patient completed questions and a care flow sheet. The other half of the enrolled practices will continue to provide "usual" care without the support of the Asthma APGAR system. The research questions is whether or not asthma control and asthma related quality of life will be improved in people with asthma who are cared for in the intervention practices that use the Asthma APGAR system.
Read the detailed description
Since this is a practice intervention study, the practices are randomized and all patients enrolled within each practice receive either the intervention based care or the usual care.
The primary outcome is asthma related quality of life obtained from patient report. Other outcomes include asthma control, also a patient reported outcome, and number of exacerbations which is obtained from patient medical record review.
- Conditions
- Asthma
- Being tested
- Use of Asthma APGAR system and tools, Asthma APGAR tools
- Keywords
- asthma, asthma care system, effectiveness, primary care, practice based research network
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Asthma APGAR system and toolsBehavioural
Practices will use the Asthma APGAR control questionnaire and the care algorithm.
Asthma APGAR toolsBehavioural
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Asthma APGAR | Experimental | Use of new asthma care tools. Primary care practices will be provided and educated about the Asthma APGAR tool system to guide asthma care. The practices will adopt this system for all people in their practices with asthma. Outcomes will be assessed only for those who meet enrollment criteria and sign informed consent. Receives: Behavioral: Use of Asthma APGAR system and tools |
| Usual care | Placebo comparator | Usual asthma care as provided by the sites. Receives: Behavioral: Asthma APGAR tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Quality of Life Questionnaire (AQLQ)
Chagne in asthma relted quality of life from basline (enrollment date) to 12 months later
Measured: 12 months
Secondary outcomes (2)
Asthma Control Questionnaire
Change in asthma control from baseline to 12 month follow up.
Measured: 12 months
Exacerbation rate
Number of emergency department visits, hospitalization and episodes of oral steroid bursts--all related to asthma, during the 12 months of follow as obtained from patient report and medical record review.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olmsted Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara P. Yawn, MD, MSc, Olmsted Medical Center
- Investigators
- Barbara P Yawn, MD MSc, Principal investigator, Olmsted Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446315
- Sponsor's protocol ID
- 1R01HS018431
- Acronym
- Asthma APGAR
- Status last verified
- Oct 2011
- First submitted
- 3 Oct 2011
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Yawn BP, Wollan PC, Rank MA, Bertram SL, Juhn Y, Pace W. Use of Asthma APGAR Tools in Primary Care Practices: A Cluster-Randomized Controlled Trial. Ann Fam Med. 2018 Mar;16(2):100-110. doi: 10.1370/afm.2179.
PubMed 29531100Rank MA, Bertram S, Wollan P, Yawn RA, Yawn BP. Comparing the Asthma APGAR system and the Asthma Control Test in a multicenter primary care sample. Mayo Clin Proc. 2014 Jul;89(7):917-25. doi: 10.1016/j.mayocp.2014.02.016. Epub 2014 May 5.
PubMed 24809759
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Decision Maker Tools for Asthma: the Asthma APGAR
- ClinicalTrials.gov ID
- NCT01446315
- Acronym / sponsor ID
- Asthma APGAR / 1R01HS018431
- Conditions
- Asthma
- Keywords
- asthma, asthma care system, effectiveness, primary care, practice based research network
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Olmsted Medical CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 5 Oct 2011 (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.
Asthma is a common problem among US adults and children. Unfortunately many people with asthma continue to suffer from asthma symptoms that could be control with better asthma care and more attention to details such as triggers, and adherence. To date the only tools available and recommended by groups such as the national asthma guideline group consider only asthma burden and do not include information on the most common factors that adversely affect asthma control. This study provides one half of the enrolled primary care offices with the Asthma APGAR which is a system of patient completed questions and a care flow sheet. The other half of the enrolled practices will continue to provide "usual" care without the support of the Asthma APGAR system. The research questions is whether or not asthma control and asthma related quality of life will be improved in people with asthma who are cared for in the intervention practices that use the Asthma APGAR system.
Detailed description
Since this is a practice intervention study, the practices are randomized and all patients enrolled within each practice receive either the intervention based care or the usual care.
The primary outcome is asthma related quality of life obtained from patient report. Other outcomes include asthma control, also a patient reported outcome, and number of exacerbations which is obtained from patient medical record review.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma APGAR | Experimental | Behavioral: Use of Asthma APGAR system and toolsUse of new asthma care tools. Primary care practices will be provided and educated about the Asthma APGAR tool system to guide asthma care. The practices will adopt this system for all people in their practices with asthma. Outcomes will be assessed only for those who meet enrollment criteria and sign informed consent. |
| Usual care | Placebo comparator | Behavioral: Asthma APGAR toolsUsual asthma care as provided by the sites. |
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Have physician diagnosed asthma
- Male or female between ages 5 through 60 years
- Have persistent asthma as assessed by daily use of "controller" medication
- Receive continuity care at practice where enrolled.
- Not have been in ICU for asthma ever
Key exclusion criteria (2 listed)
- Cannot read and speak English
- Child refuses assent
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 |
|---|---|---|
| Use of Asthma APGAR system and toolsPractices will use the Asthma APGAR control questionnaire and the care algorithm. | Behavioural | Asthma APGAR |
| Asthma APGAR toolsUsual care | Behavioural | Usual care |
Primary outcome
Asthma Quality of Life Questionnaire (AQLQ)
Time frame: 12 months
Chagne in asthma relted quality of life from basline (enrollment date) to 12 months later
2 secondary outcomes
Asthma Control Questionnaire
Time frame: 12 months
Exacerbation rate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2011.
- Derived from this study: PubMed 29531100Yawn BP, Wollan PC, Rank MA, Bertram SL, Juhn Y, Pace W. Use of Asthma APGAR Tools in Primary Care Practices: A Cluster-Randomized Controlled Trial. Ann Fam Med. 2018 Mar;16(2):100-110. doi: 10.1370/afm.2179.
- Derived from this study: PubMed 24809759Rank MA, Bertram S, Wollan P, Yawn RA, Yawn BP. Comparing the Asthma APGAR system and the Asthma Control Test in a multicenter primary care sample. Mayo Clin Proc. 2014 Jul;89(7):917-25. doi: 10.1016/j.mayocp.2014.02.016. Epub 2014 May 5.
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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.
Barbara P Yawn, MD MSc principal investigator
Olmsted Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Use of Asthma APGAR system and tools and Asthma APGAR tools in people with Asthma, run by Olmsted Medical Center 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 2 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: status not confirmed, as of the sponsor's last update on 5 Oct 2011. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Asthma Quality of Life Questionnaire (AQLQ) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01446315, which also lists 2 linked publications.
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 5 Oct 2011.