Assessing Decision Maker Tools for Asthma: the Asthma APGAR (Asthma APGAR)
Primary Purpose
Asthma
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Use of Asthma APGAR system and tools
Asthma APGAR tools
Sponsored by

About this trial
This is an interventional treatment trial for Asthma focused on measuring asthma, asthma care system, effectiveness, primary care, practice based research network
Eligibility Criteria
Inclusion Criteria:
- Have physician diagnosed asthma
- Male or female between ages 5 through 60 years
- Have persistent asthma as assessed by daily use of "controller" medication
- Receive continuity care at practice where enrolled.
- Not have been in ICU for asthma ever
- Do not require daily or every other day oral steroids for asthma control
Exclusion Criteria:
- Cannot read and speak English
- Child refuses assent
Sites / Locations
- Olmsted Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Asthma APGAR
Usual care
Arm Description
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.
Usual asthma care as provided by the sites.
Outcomes
Primary Outcome Measures
Asthma Quality of Life Questionnaire (AQLQ)
Chagne in asthma relted quality of life from basline (enrollment date) to 12 months later
Secondary Outcome Measures
Asthma Control Questionnaire
Change in asthma control from baseline to 12 month follow up.
Exacerbation rate
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.
Full Information
NCT ID
NCT01446315
First Posted
October 3, 2011
Last Updated
October 4, 2011
Sponsor
Olmsted Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01446315
Brief Title
Assessing Decision Maker Tools for Asthma: the Asthma APGAR
Acronym
Asthma APGAR
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Olmsted Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, asthma care system, effectiveness, primary care, practice based research network
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Asthma APGAR
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Placebo Comparator
Arm Description
Usual asthma care as provided by the sites.
Intervention Type
Behavioral
Intervention Name(s)
Use of Asthma APGAR system and tools
Intervention Description
Practices will use the Asthma APGAR control questionnaire and the care algorithm.
Intervention Type
Behavioral
Intervention Name(s)
Asthma APGAR tools
Intervention Description
Usual care
Primary Outcome Measure Information:
Title
Asthma Quality of Life Questionnaire (AQLQ)
Description
Chagne in asthma relted quality of life from basline (enrollment date) to 12 months later
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Asthma Control Questionnaire
Description
Change in asthma control from baseline to 12 month follow up.
Time Frame
12 months
Title
Exacerbation rate
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have physician diagnosed asthma
Male or female between ages 5 through 60 years
Have persistent asthma as assessed by daily use of "controller" medication
Receive continuity care at practice where enrolled.
Not have been in ICU for asthma ever
Do not require daily or every other day oral steroids for asthma control
Exclusion Criteria:
Cannot read and speak English
Child refuses assent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara P Yawn, MD MSc
Organizational Affiliation
Olmsted Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Olmsted Medical Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55904
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29531100
Citation
Yawn BP, Wollan PC, Rank MA, Bertram SL, Juhn Y, Pace W. Use of Asthma APGAR Tools in Primary Care Practices: A Cluster-Randomized Controlled Trial. Ann Fam Med. 2018 Mar;16(2):100-110. doi: 10.1370/afm.2179.
Results Reference
derived
PubMed Identifier
24809759
Citation
Rank MA, Bertram S, Wollan P, Yawn RA, Yawn BP. Comparing the Asthma APGAR system and the Asthma Control Test in a multicenter primary care sample. Mayo Clin Proc. 2014 Jul;89(7):917-25. doi: 10.1016/j.mayocp.2014.02.016. Epub 2014 May 5.
Results Reference
derived
Learn more about this trial
Assessing Decision Maker Tools for Asthma: the Asthma APGAR
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