NCT00217945

Brief Summary

To evaluate a model of shared decision-making for asthma treatment, appropriate to the needs of African American, Latino, Chinese, and other Asian and low income Caucasian patients to adherence to asthma controller medications in a two-year randomized clinical trial in 302 minority and low-income adults, 18-70 years of age, with suboptimally controlled, persistent asthma, paralleling a simultaneous evaluation being conducted in 311 Caucasian and Asian/Pacific Island adults, (total n=613), and to examine psychological mechanisms mediating the effects of the intervention on adherence and of adherence on asthma outcomes.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 2001

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

July 29, 2016

Status Verified

January 1, 2008

Enrollment Period

5.9 years

First QC Date

September 19, 2005

Last Update Submit

July 28, 2016

Conditions

Interventions

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Kaiser Health Care Program member for more than 1 yr. * Site: Portland, OR, Honolulu, HI, San Francisco, Oakland, or Richmond, CA. * Confirmed diagnosis of persistent asthma with currently prescribed medications; no daily or alternate daily oral corticosteroid * Evidence of poorly controlled asthma: score of \>=1 on ATAQ asthma control questionnaire1 and either overuse of rescue medication vs. controller medications and/or recent emergency visit or hospitalization for asthma * COPD not the primary lung disease diagnosis * Regular use of Inhaled Corticosteroid (ICS) and current/ex-smokers: \>= 8% increase in FEV1 post-bronchodilator; if no routine ICS use +/- smoking HX: \>= 12% increase required; non-smokers using ICS regularly not required to reverse

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (2)

  • Wilson SR, Buist AS, Holup J, Brown NL, Lapidus J, Luna V, Verghese S. Shared Decision Making vs. Management by Guidelines: Impact on Medication Regimen. Poster presented at the 2005 Annual Meeting of the American Thoracic Society, San Diago, CA, May 24, 2005. Proceedings of the American Thoracic Society; Vol.2 Abstracts Issue; 2005.

    BACKGROUND
  • Wilson SR, Strub P, Buist AS, Knowles SB, Lavori PW, Lapidus J, Vollmer WM; Better Outcomes of Asthma Treatment (BOAT) Study Group. Shared treatment decision making improves adherence and outcomes in poorly controlled asthma. Am J Respir Crit Care Med. 2010 Mar 15;181(6):566-77. doi: 10.1164/rccm.200906-0907OC. Epub 2009 Dec 17.

MeSH Terms

Conditions

Lung DiseasesAsthma

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesBronchial DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Sandra Wilson

    Palo Alto Medical Foundation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

September 1, 2001

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

July 29, 2016

Record last verified: 2008-01