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Assessing Decision Maker Tools for Asthma: the Asthma APGAR

NCT ID: NCT01446315

Last Updated: 2011-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Use of Asthma APGAR system and tools

Intervention Type BEHAVIORAL

Practices will use the Asthma APGAR control questionnaire and the care algorithm.

Usual care

Usual asthma care as provided by the sites.

Group Type PLACEBO_COMPARATOR

Asthma APGAR tools

Intervention Type BEHAVIORAL

Usual care

Interventions

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Use of Asthma APGAR system and tools

Practices will use the Asthma APGAR control questionnaire and the care algorithm.

Intervention Type BEHAVIORAL

Asthma APGAR tools

Usual care

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Olmsted Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Barbara P. Yawn, MD, MSc

Director of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara P Yawn, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Olmsted Medical Center

Locations

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Olmsted Medical Center

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29531100 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24809759 (View on PubMed)

Other Identifiers

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1R01HS018431

Identifier Type: AHRQ

Identifier Source: org_study_id

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