Assessing Decision Maker Tools for Asthma: the Asthma APGAR
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Olmsted Medical Center
- Enrollment
- 1,500
- Locations
- 1
- Primary Endpoint
- Asthma Quality of Life Questionnaire (AQLQ)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Use of Asthma APGAR system and tools (Behavioral)
Usual care
Usual asthma care as provided by the sites.
Intervention: Asthma APGAR tools (Behavioral)
Outcomes
Primary Outcomes
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 Outcomes
- Exacerbation rate(12 months)
- Asthma Control Questionnaire(12 months)
Investigators
Barbara P. Yawn, MD, MSc
Director of Research
Olmsted Medical Center