Assessing Decision Maker Tools for Asthma: the Asthma APGAR

Asthma Clinical Trial

— Asthma APGAR  

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01446315
• Other study ID #: 1R01HS018431
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: October 3, 2011
• Last updated: October 4, 2011
• Start date: October 2011
• Est. completion date: October 2014

Study information

• Verified date: October 2011
• Source: Olmsted Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1500
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Use of Asthma APGAR system and tools
Practices will use the Asthma APGAR control questionnaire and the care algorithm.
• Asthma APGAR tools
Usual care

Locations

Country	Name	City	State
United States	Olmsted Medical Center	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Olmsted Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Quality of Life Questionnaire (AQLQ)	Chagne in asthma relted quality of life from basline (enrollment date) to 12 months later	12 months	Yes
Secondary	Asthma Control Questionnaire	Change in asthma control from baseline to 12 month follow up.	12 months	No
Secondary	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.	12 months	No