Assessing Decision Maker Tools for Asthma: the Asthma APGAR

Phase 4

• Conditions: Asthma
• Interventions: Behavioral: Asthma APGAR tools; Behavioral: Use of Asthma APGAR system and tools

• Registration Number: NCT01446315
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2011-10
• Study Start: 2011-10
• Study First Submitted: 2011-10-03
• Study First Submitted QC: 2011-10-04
• Last Update Submitted: 2011-10-04
• Study First Posted: 2011-10-05
• Last Update Posted: 2011-10-05
• Primary Completion: 2014-10
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Usual care	Asthma APGAR tools	Usual asthma care as provided by the sites.
Asthma APGAR	Use of Asthma APGAR system and tools	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.

Primary Outcome Measures

Name	Time	Method
Asthma Quality of Life Questionnaire (AQLQ)	12 months	Chagne in asthma relted quality of life from basline (enrollment date) to 12 months later

Secondary Outcome Measures

Name	Time	Method
Exacerbation rate	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.
Asthma Control Questionnaire	12 months	Change in asthma control from baseline to 12 month follow up.

Trial Locations

Locations (1)

Olmsted Medical Center; 🇺🇸 Rochester, Minnesota, United States