Clinical trial NCT01446315: Assessing Decision Maker Tools for Asthma: the Asthma APGAR
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Asthma
Keywords: asthma
asthma care system
effectiveness
primary care
practice based research network
Lead sponsor: Olmsted Medical Center
Sponsor class: OTHER
First posted: 2011-10-05
Enrollment: 1500
Sex: ALL
Minimum age (years): 5
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: 12 months
Secondary outcomes:
measure: Asthma Control Questionnaire
timeFrame: 12 months
measure: Exacerbation rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Olmsted Medical Center
state: Minnesota
Study officials:
affiliation: Olmsted Medical Center
name: Barbara P Yawn, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.