Self-care Decision-making: Feasibility of the BREATHE Asthma Intervention Trial - Phase II (Part 2 - a Pilot Randomized Trial Phase)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Asthma Control Questionnaire (ACQ) Score
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •adults (> or = 18 years of age) who self-report race as Black or African American
- •with PCP-diagnosed persistent asthma
- •prescribed ICS
- •receiving asthma care at participating FQHCs
- •who have uncontrolled asthma
- •have erroneous personal health and/or negative ICS beliefs
- •Exclusion Criteria:
- •participation in Phase 1 (Part 1) of the BREATHE trial (focus groups)
- •non-English speaking
- •serious mental health conditions (e.g., psychosis) that preclude completion of study procedures or confound analyses
结局指标
主要结局
Asthma Control Questionnaire (ACQ) Score
时间窗: 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
次要结局
- Asthma Quality of Life Questionnaire (AQLQ) Score(Baseline, 1 Month, 2 Months, 3 Months (post-intervention))
- Medication Adherence Record Scale-Asthma (MARS-A) Score(Baseline, 1 Month, 2 Months, 3 Months (post-intervention))
研究者
Maureen George
Associate Professor of Nursing at the Columbia University Medical Center, Nursing Scholarship & Research
Columbia University