AsthmaAIQNCT01296477
To Evaluate the Use of ASTHMA IQ in a Primary Care Setting
An observational study of Asthma, run by American Academy of Family Physicians at 1 site in United States.
Trial summary
There is a mounting body of evidence suggesting that there is a large disparity between the development and the actual implementation of guideline-driven asthma care in primary and specialty care practices. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Asthma
- How many people
- 375 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Sep 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will recruit approximately 400 patients with chronic persistent asthma. The required sample size to identify a clinically significant difference in ACT scores from baseline and between groups requires about 200 patients per group.
Who may be able to join
- Male or female patients, age 12 through 65 years at the time of screening;
- Written informed consent obtained from the patient prior to beginning study procedures;
- Documented clinical history of chronic persistent asthma requiring controller therapy;
- Able to complete the study period, including follow-up period, of up to approximately 2 years; and
- Willing to forego other forms of experimental treatment and study procedures during the study and for 30 days after the follow-up period is completed.
Who cannot join
- History of any disease, evidence of any current disease (other than asthma), any finding upon physical examination, or any laboratory abnormality, that, in the opinion of the investigator, may compromise the safety of the patient in the study or confound the analysis of the study;
- Lung disease other than asthma (e.g., chronic obstructive pulmonary disease, cystic fibrosis);
- Any disease or illness, other than asthma, that is likely to require the use of systemic corticosteroids during the study period;
- Current acute illnesses or evidence of significant active infection, such as fever ≥ 38.0°C (100.5°F) within 4 weeks of enrollment;
- Receipt of any investigational drug therapy within 30 days or any biologic(s) within 5 half-lives prior to screening, except omalizumab for asthma;
- Pregnancy at enrollment;
Show all 14Show fewer
- Breastfeeding or lactating females;
- Elective major surgery planned from screening through study completion;
- History of cancer other than basal cell carcinoma of the skin or cervical carcinoma-in-situ treated with apparent success with curative therapy more than 1 year prior to enrollment;
- History of primary immunodeficiency;
- History within the past year of excessive alcohol intake or drug addiction.
- History of tobacco use of more than 10 pack years;
- Plans to move from the study site area during the duration of the study.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
AAFP National Research Network
Leawood, Kansas, 66211
About this study
Official title: Examination of ASTHMA IQ to Improve Patient Outcomes in a Primary Care Setting
There is a mounting body of evidence suggesting that there is a large disparity between the development and the actual implementation of guideline-driven asthma care in primary and specialty care practices. To address this disparity, the American Academy of Allergy, Asthma \& Immunology (AAAAI) developed a unique, comprehensive and easy-to-use Web-based tool for clinicians who treat asthma patients called "Asthma Specialist Tool to Help Manage Asthma and Improve Quality" (Asthma-IQ). This study will examine whether the use of the Asthma IQ primary care tool will improve asthma care and asthma outcomes using a randomized trial of the Asthma IQ system versus usual asthma care in the primary care setting over 1 year. At the end of 1 year, all patients will be managed using the Asthma-IQ tool for an additional year to determine if the patients managed by usual care in the first year improve when managed in conjunction with Asthma-IQ. The primary endpoint to determine if the use of the Asthma IQ tool will improve asthma patient outcomes is quarterly assessments of Asthma Control Test (ACT) scores via automated / electronic patient survey. The secondary endpoint is asthma exacerbations and there are a number of exploratory endpoints to further define the clinical utility of the primary care version of Asthma-IQ. This study will involve recruiting approximately 20 family medicine offices with approximately 20 patients each, to conduct this randomized, multiple time point intervention trial. The necessary total recruited patient sample size is 200 per group. The results of this study will help determine the utility of Web-based tools to help manage chronic diseases such as asthma.
- Conditions
- Asthma
- Keywords
- Asthma, ASTHMA IQ tool, Asthma Control Test (ACT), EPR-3 Guidelines, Exacerbations
- 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 |
|---|---|---|
| Asthma IQ Primary Care Tool | Not described | |
| Usual Asthma Care in Primary Care | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACT scores via automated / electronic patient survey
Measured: 2 years (Surveys measured at every 3 months including baseline)
Secondary outcomes (1)
Asthma exacerbations requiring the use of inhaled corticosteroids via chart reviews and automated survey
Measured: 2 years (Chart reviews performed at every 6 months and surveys measured at every 3 months including baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startDec 2010
- Primary completionJul 2015
- Study completionSep 2015
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Academy of Family Physicians
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Allergy, Asthma, and Immunology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296477
- Sponsor's protocol ID
- 10-115
- Acronym
- AIQ
- Status last verified
- Jan 2016
- First submitted
- 14 Feb 2011
- Last updated
- 5 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of ASTHMA IQ to Improve Patient Outcomes in a Primary Care Setting
- ClinicalTrials.gov ID
- NCT01296477
- Acronym / sponsor ID
- AIQ / 10-115
- Conditions
- Asthma
- Keywords
- Asthma, ASTHMA IQ tool, Asthma Control Test (ACT), EPR-3 Guidelines, Exacerbations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- American Academy of Family PhysiciansUniversity, hospital or other
- Collaborators
- American Academy of Allergy, Asthma, and Immunology
- Study start
- Dec 2010
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 15 Feb 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.
There is a mounting body of evidence suggesting that there is a large disparity between the development and the actual implementation of guideline-driven asthma care in primary and specialty care practices. To address this disparity, the American Academy of Allergy, Asthma \& Immunology (AAAAI) developed a unique, comprehensive and easy-to-use Web-based tool for clinicians who treat asthma patients called "Asthma Specialist Tool to Help Manage Asthma and Improve Quality" (Asthma-IQ). This study will examine whether the use of the Asthma IQ primary care tool will improve asthma care and asthma outcomes using a randomized trial of the Asthma IQ system versus usual asthma care in the primary care setting over 1 year. At the end of 1 year, all patients will be managed using the Asthma-IQ tool for an additional year to determine if the patients managed by usual care in the first year improve when managed in conjunction with Asthma-IQ. The primary endpoint to determine if the use of the Asthma IQ tool will improve asthma patient outcomes is quarterly assessments of Asthma Control Test (ACT) scores via automated / electronic patient survey. The secondary endpoint is asthma exacerbations and there are a number of exploratory endpoints to further define the clinical utility of the primary care version of Asthma-IQ. This study will involve recruiting approximately 20 family medicine offices with approximately 20 patients each, to conduct this randomized, multiple time point intervention trial. The necessary total recruited patient sample size is 200 per group. The results of this study will help determine the utility of Web-based tools to help manage chronic diseases such as asthma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma IQ Primary Care Tool | – | – |
| Usual Asthma Care in Primary Care | – | – |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will recruit approximately 400 patients with chronic persistent asthma. The required sample size to identify a clinically significant difference in ACT scores from baseline and between groups requires about 200 patients per group.
Key inclusion criteria (5 listed)
- Male or female patients, age 12 through 65 years at the time of screening;
- Written informed consent obtained from the patient prior to beginning study procedures;
- Documented clinical history of chronic persistent asthma requiring controller therapy;
- Able to complete the study period, including follow-up period, of up to approximately 2 years; and
- Willing to forego other forms of experimental treatment and study procedures during the study and for 30 days after the follow-up period is completed.
Key exclusion criteria (14 listed)
- History of any disease, evidence of any current disease (other than asthma), any finding upon physical examination, or any laboratory abnormality, that, in the opinion of the investigator, may compromise the safety of the patient in the study or confound the analysis of the study;
- Lung disease other than asthma (e.g., chronic obstructive pulmonary disease, cystic fibrosis);
- Any disease or illness, other than asthma, that is likely to require the use of systemic corticosteroids during the study period;
- Current acute illnesses or evidence of significant active infection, such as fever ≥ 38.0°C (100.5°F) within 4 weeks of enrollment;
- Receipt of any investigational drug therapy within 30 days or any biologic(s) within 5 half-lives prior to screening, except omalizumab for asthma;
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
ACT scores via automated / electronic patient survey
Time frame: 2 years (Surveys measured at every 3 months including baseline)
1 secondary outcome
Asthma exacerbations requiring the use of inhaled corticosteroids via chart reviews and automated survey
Time frame: 2 years (Chart reviews performed at every 6 months and surveys measured at every 3 months including baseline)
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 5 Jan 2016.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 American Academy of Family Physicians 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 5 inclusion and 14 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 5 Jan 2016. 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?
ACT scores via automated / electronic patient survey (time frame: 2 years (Surveys measured at every 3 months including baseline)). 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 5 Jan 2016.