To Evaluate the Use of ASTHMA IQ in a Primary Care Setting
| Status: | Completed |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 12 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | December 2010 |
| End Date: | September 2015 |
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.
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.
Inclusion Criteria:
1. Male or female patients, age 12 through 65 years at the time of screening;
2. Written informed consent obtained from the patient prior to beginning study
procedures;
3. Documented clinical history of chronic persistent asthma requiring controller
therapy;
4. Able to complete the study period, including follow-up period, of up to approximately
2 years; and
5. 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.
Exclusion Criteria:
1. 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;
2. Lung disease other than asthma (e.g., chronic obstructive pulmonary disease, cystic
fibrosis);
3. Any disease or illness, other than asthma, that is likely to require the use of
systemic corticosteroids during the study period;
4. Current acute illnesses or evidence of significant active infection, such as fever ≥
38.0°C (100.5°F) within 4 weeks of enrollment;
5. Receipt of any investigational drug therapy within 30 days or any biologic(s) within
5 half-lives prior to screening, except omalizumab for asthma;
6. Pregnancy at enrollment;
7. Breastfeeding or lactating females;
8. Elective major surgery planned from screening through study completion;
9. 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;
10. History of primary immunodeficiency;
11. History within the past year of excessive alcohol intake or drug addiction.
12. History of tobacco use of more than 10 pack years;
13. Plans to move from the study site area during the duration of the study.
Other protocol-defined inclusion/exclusion criteria may apply
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