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Lung DiseasesNCT00217945

Does Shared Decision-Making Improve Adherence in Asthma

A study testing Shared-Decision Making in people with Lung Diseases and Asthma, run by National Heart, Lung, and Blood Institute (NHLBI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lung Diseases, Asthma
What is being tested?
Shared-Decision Making
How many people
Not given
Where
No sites listed yet
Study dates
Sep 2001to Aug 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  • 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

About this study

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.

Read the detailed description

BACKGROUND:

Asthma is a chronic inflammatory disorder of the airways. Despite major advances in understanding of its pathophysiology and management, asthma outcomes have not shown parallel improvement. Many patients with asthma are poorly controlled and have sub-optimal health status. Asthma care management by a trained non-physician health professional has developed as a means of addressing the problems of patients evidencing poor control and/or poor adherence to controller medications. Shared decision making (SDM) between clinician and patient has also been proposed as a means of getting greater patient involvement in their care, with the idea that this may improve medication adherence and outcomes. However, significant patient involvement also might result in less adequate regimens than would management based on guidelines (MBG). Even so, increased adherence to a less adequate regimen might result in better outcomes than poor adherence to an optimal regimen.

DESIGN NARRATIVE:

Better Outcomes of Asthma Treatment (BOAT) is a randomized controlled trial (a collaborative study designed to compare the effectiveness of three strategies for managing patients, 18-70 years of age, with suboptimally controlled, persistent asthma. The three treatment strategies are: usual care (UC); management by guidelines (MG); and a third, shared decision making (SDM) arm, that seeks to formally involve the patient in the therapeutic decision-making process. Under the present grant, 302 study participants were recruited from the membership of the Kaiser Permanente - Northern California Region (KPNC), San Francisco, Oakland, and Richmond medical centers. In the collaborating grant (No.HL67092-03) 311 patients were recruited from Kaiser Permanente clinical facilities in Portland, OR, and Honolulu, HI. Patients were randomized equally to the three treatment arms following baseline assessment of asthma control, medication use, lung function, and other behavioral and psychological characteristics. Their health care utilization for asthma and acquisition of asthma medications is being followed for a total of 24 months post-randomization through health system records, and they are being reassessed at 12 mos. Those assigned to the care management conditions received asthma education and objective feedback on their level of asthma control. Those assigned to the MBG condition were prescribed a regimen appropriate to the severity of their asthma in accordance with standard guidelines for asthma management. Those assigned to the SDM condition participated in a process to elicit their goals for their asthma treatment and their priorities regarding their asthma medications, and then engaged in a process of shared decision making with the care manager designed to arrive at a prescribed regimen that satisfied their goals and preferences. Analysis of the data will compare the two care management approaches with usual care and with each other in terms of the primary outcomes.

Being tested
Shared-Decision Making
Medical subject headings
Lung Diseases, Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shared-Decision MakingBehavioural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startSep 2001
  3. Primary completionAug 2007
  4. Study completionAug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00217945
Sponsor's protocol ID
294
Other IDs
R01HL069358
Status last verified
Jan 2008
First submitted
19 Sep 2005
Last updated
29 Jul 2016
Results posted
No

Publications

  • 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.

  • 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.

    PubMed 20019345

Questions about this trial

What is this clinical trial studying?

A study testing Shared-Decision Making in people with Lung Diseases and Asthma, run by National Heart, Lung, and Blood Institute (NHLBI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00217945, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016; AzTrials last refreshed its copy on 28 Oct 2026.

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