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Validation of the BREATHE Asthma Intervention Trial

2021年9月1日 更新者：Maureen George、Columbia University

Self-care Decision-making: Feasibility of the BREATHE Asthma Intervention Trial - Phase II (Part 2 - a Pilot Randomized Trial Phase)

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).

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • New York
      • New York、New York、美国、10032
        • Columbia University Medical Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

PROVIDER RECRUITMENT

Inclusion Criteria:

  • PCPs (MDs and Nurse Practitioners (NPs)/Physician Assistants (PAs)) working in family, primary or internal medicine care services
  • Who have at least 40 adult patients with persistent asthma (defined as having been prescribed ICS) on their patient panel

Exclusion Criteria:

  • PCPs whose primary focus is outside of adult health services (family, primary or internal medicine), such as behavioral health, pediatrics and Obstetrics and Gynaecology (OB-GYN)

PATIENT RECRUITMENT

Inclusion Criteria:

Patients must be

  1. adults (> or = 18 years of age) who self-report race as Black or African American
  2. with PCP-diagnosed persistent asthma
  3. prescribed ICS
  4. receiving asthma care at participating FQHCs
  5. who have uncontrolled asthma
  6. have erroneous personal health and/or negative ICS beliefs

Exclusion Criteria:

  1. participation in Phase 1 (Part 1) of the BREATHE trial (focus groups)
  2. non-English speaking
  3. serious mental health conditions (e.g., psychosis) that preclude completion of study procedures or confound analyses

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：BREATHE Intervention
The patient's primary care provider (PCP) will deliver the active intervention (shared decision-making discussion of asthma control status and treatment) - BREATHE Intervention.
行为的：BREATHE Intervention
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.
有源比较器：Control Intervention
The patient's primary care provider (PCP) will deliver the control intervention (discussion of healthy lifestyles).
行为的：Control Intervention
PCP will provide discussion of healthy lifestyles.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Asthma Control Questionnaire (ACQ) Score
大体时间：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
Baseline, 1 Month, 2 Months, 3 Months (post-intervention)

次要结果测量

结果测量
措施说明
大体时间
Asthma Quality of Life Questionnaire (AQLQ) Score
大体时间：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)
Baseline, 1 Month, 2 Months, 3 Months (post-intervention)
Medication Adherence Record Scale-Asthma (MARS-A) Score
大体时间：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)
Baseline, 1 Month, 2 Months, 3 Months (post-intervention)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Columbia University

调查人员

  • 首席研究员：Maureen George, PhD、Associate Professor of Nursing at Columbia University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年10月1日

初级完成 (实际的)

2019年5月29日

研究完成 (实际的)

2019年5月30日

研究注册日期

首次提交

2017年9月29日

首先提交符合 QC 标准的

2017年9月29日

首次发布 (实际的)

2017年10月3日

研究记录更新

最后更新发布 (实际的)

2021年9月28日

上次提交的符合 QC 标准的更新

2021年9月1日

最后验证

2021年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • AAAR5216

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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条件

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