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Assessing Decision Maker Tools for Asthma: the Asthma APGAR (Asthma APGAR)

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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
Information provided by (Responsible Party):
Barbara P. Yawn, MD, MSc, Olmsted Medical Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Use of Asthma APGAR system and tools Behavioral: Asthma APGAR tools Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2011
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
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
Usual care

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Asthma Control Questionnaire [ Time Frame: 12 months ]
    Change in asthma control from baseline to 12 month follow up.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Have physician diagnosed asthma
  2. Male or female between ages 5 through 60 years
  3. Have persistent asthma as assessed by daily use of "controller" medication
  4. Receive continuity care at practice where enrolled.
  5. Not have been in ICU for asthma ever
  6. Do not require daily or every other day oral steroids for asthma control

Exclusion Criteria:

  1. Cannot read and speak English
  2. Child refuses assent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446315

United States, Minnesota
Olmsted Medical Center
Rochester, Minnesota, United States, 55904
Sponsors and Collaborators
Olmsted Medical Center
Principal Investigator: Barbara P Yawn, MD MSc Olmsted Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barbara P. Yawn, MD, MSc, Director of Research, Olmsted Medical Center
ClinicalTrials.gov Identifier: NCT01446315     History of Changes
Other Study ID Numbers: 1R01HS018431 ( U.S. AHRQ Grant/Contract )
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: October 5, 2011
Last Verified: October 2011

Keywords provided by Barbara P. Yawn, MD, MSc, Olmsted Medical Center:
asthma care system
primary care
practice based research network

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases