Assessing Decision Maker Tools for Asthma: the Asthma APGAR (Asthma APGAR)
|ClinicalTrials.gov Identifier: NCT01446315|
Recruitment Status : Unknown
Verified October 2011 by Barbara P. Yawn, MD, MSc, Olmsted Medical Center.
Recruitment status was: Enrolling by invitation
First Posted : October 5, 2011
Last Update Posted : October 5, 2011
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Behavioral: Use of Asthma APGAR system and tools Behavioral: Asthma APGAR tools||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1500 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||October 2014|
|Estimated Study Completion Date :||October 2014|
Experimental: Asthma APGAR
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.
Behavioral: Use of Asthma APGAR system and tools
Practices will use the Asthma APGAR control questionnaire and the care algorithm.
Placebo Comparator: Usual care
Usual asthma care as provided by the sites.
Behavioral: Asthma APGAR tools
- 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
- Asthma Control Questionnaire [ Time Frame: 12 months ]Change in asthma control from baseline to 12 month follow up.
- Exacerbation rate [ Time Frame: 12 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446315
|United States, Minnesota|
|Olmsted Medical Center|
|Rochester, Minnesota, United States, 55904|
|Principal Investigator:||Barbara P Yawn, MD MSc||Olmsted Medical Center|