Assessing Decision Maker Tools for Asthma: the Asthma APGAR

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Barbara P. Yawn, MD, MSc, Olmsted Medical Center
ClinicalTrials.gov Identifier:
NCT01446315
First received: October 3, 2011
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Asthma
Behavioral: Use of Asthma APGAR system and tools
Behavioral: Asthma APGAR tools
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Olmsted Medical Center:

Primary Outcome Measures:
  • Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Chagne in asthma relted quality of life from basline (enrollment date) to 12 months later


Secondary Outcome Measures:
  • Asthma Control Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in asthma control from baseline to 12 month follow up.

  • Exacerbation rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1500
Study Start Date: October 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Use of Asthma APGAR system and tools
Practices will use the Asthma APGAR control questionnaire and the care algorithm.
Placebo Comparator: Usual care
Usual asthma care as provided by the sites.
Behavioral: Asthma APGAR tools
Usual care

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.

  Eligibility

Ages Eligible for Study:   5 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446315

Locations
United States, Minnesota
Olmsted Medical Center
Rochester, Minnesota, United States, 55904
Sponsors and Collaborators
Olmsted Medical Center
Investigators
Principal Investigator: Barbara P Yawn, MD MSc Olmsted Medical Center
  More Information

No publications provided by Olmsted Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barbara P. Yawn, MD, MSc, Director of Research, Olmsted Medical Center
ClinicalTrials.gov Identifier: NCT01446315     History of Changes
Other Study ID Numbers: 1R01 HS018431
Study First Received: October 3, 2011
Last Updated: October 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Olmsted Medical Center:
asthma
asthma care system
effectiveness
primary care
practice based research network

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on October 16, 2014