- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01296477
To Evaluate the Use of ASTHMA IQ in a Primary Care Setting (AIQ)
January 4, 2016 updated by: American Academy of Family Physicians
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
375
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kansas
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Leawood, Kansas, United States, 66211
- AAFP National Research Network
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Asthma IQ Primary Care Tool
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Usual Asthma Care in Primary Care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ACT scores via automated / electronic patient survey
Time Frame: 2 years (Surveys measured at every 3 months including baseline)
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2 years (Surveys measured at every 3 months including baseline)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
2 years (Chart reviews performed at every 6 months and surveys measured at every 3 months including baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
February 14, 2011
First Submitted That Met QC Criteria
February 14, 2011
First Posted (Estimate)
February 15, 2011
Study Record Updates
Last Update Posted (Estimate)
January 5, 2016
Last Update Submitted That Met QC Criteria
January 4, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-115
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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