Columbia University Medical Center
New York, 10032, United States
NCT Number: NCT03300752
The overall goal of this study to preliminarily validate a novel intervention delivered by primary care providers (PCPs) to their Black adult patients with uncontrolled asthma in federally qualified health centers (FQHCs).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
New York, 10032, United States
Nearly every asthma related hospitalization and death could be prevented with appropriate self-management that achieves and maintains disease control. However, as many as 64% of adults have uncontrolled asthma; minorities are disproportionately represented within that population. While inhaled corticosteroids (ICS) are a safe and effective treatment for uncontrolled asthma, relative to Whites, Blacks have lower rates of ICS adherence.
Black adults with uncontrolled asthma experience profound health disparities. Despite data that point to the critical need for enhanced asthma self-management, rates of controlled asthma are well below Healthy People 2020 targets, particularly among vulnerable populations. This Brief Evaluation of Asthma Therapy (BREATHE) intervention has the potential to offer a new avenue to asthma control via shared decision-making that supports ICS adherence.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
PROVIDER RECRUITMENT
Inclusion criteria
Exclusion criteria
PATIENT RECRUITMENT
Inclusion criteria
Patients must be
Exclusion criteria
PCPs randomized to BREATHE will receive the tablet which, when the screen is advanced by the PCP, will prompt the PCP through a 7-minute, 4-step brief intervention tailored to respond to the patient's specific beliefs, and shared decision-making discussion of asthma control status and treatment.
PCP will provide discussion of healthy lifestyles.
Time frame: Baseline, 1 Month, 2 Months, 3 Months (post-intervention)
Full title: Asthma Control Questionnaire Construct measured: self-reported asthma control Scoring: 0 points = total asthma control/ best outcome, 6 points = completely uncontrolled asthma/ worst outcome
Time frame: Baseline, 1 Month, 2 Months, 3 Months (post-intervention)
Full title: Asthma Quality of Life Questionnaire Construct: quality of life for patients with asthma Scoring: 32 items, each scored 1-7. The total score is calculated as a mean of all 32 items (1= low quality of life/ worse outcome, 7= high quality of life/ best outcome)
Time frame: Baseline, 1 Month, 2 Months, 3 Months (post-intervention)
Full title: Medication Adherence Record Scale- Asthma Construct: Adherence to inhaled corticosteroid medications Scoring: Total score is calculated as a mean of the 10 items, scores range from 1-5 (1= low adherence/ worse outcome, 5= high adherence/ best outcome)
Columbia University
Other
Self-care Decision-making: Feasibility of the BREATHE Asthma Intervention Trial - Phase II (Part 2 - a Pilot Randomized Trial Phase)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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