NCT01446315

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for phase_4 asthma

Timeline
Completed

Started Oct 2011

Typical duration for phase_4 asthma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 5, 2011

Status Verified

October 1, 2011

Enrollment Period

3 years

First QC Date

October 3, 2011

Last Update Submit

October 4, 2011

Conditions

Asthma

Keywords

asthmaasthma care systemeffectivenessprimary carepractice based research network

Outcome Measures

Primary Outcomes (1)

  • Asthma Quality of Life Questionnaire (AQLQ)

    Chagne in asthma relted quality of life from basline (enrollment date) to 12 months later

    12 months

Secondary Outcomes (2)

  • Asthma Control Questionnaire

    12 months

  • Exacerbation rate

    12 months

Study Arms (2)

Asthma APGAR

EXPERIMENTAL

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.

Behavioral: Use of Asthma APGAR system and tools

Usual care

PLACEBO COMPARATOR

Usual asthma care as provided by the sites.

Behavioral: Asthma APGAR tools

Interventions

Use of Asthma APGAR system and toolsBEHAVIORAL

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

Asthma APGAR
Asthma APGAR toolsBEHAVIORAL

Usual care

Usual care

Eligibility Criteria

Age5 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Cannot read and speak English
  • Child refuses assent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Olmsted Medical Center

Rochester, Minnesota, 55904, United States

Location

Related Publications (2)

  • 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.

    PMID: 29531100DERIVED

  • 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.

    PMID: 24809759DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Barbara P Yawn, MD MSc

    Olmsted Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research

Study Record Dates

First Submitted

October 3, 2011

First Posted

October 5, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 5, 2011

Record last verified: 2011-10

Locations

US(1)