A Randomized Trial of Perception of Airflow Limitation Training to Improve Outcomes for Older Adults With Asthma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Peak expiratory flow (PEF) Values
研究概览
简要总结
Asthma affects 8% of the United States population ages >60 years and causes considerable harm: older adults are 4 times more likely to die from asthma and have twice the risk of hospitalization. The burden of asthma is notably greater among minoritized older adults. Research suggests that perception of expiratory airflow limitation may be a major determinant of asthma outcomes in older adults, and that older adults are substantially less aware of airway obstruction than younger adults. These observations suggest that perception of airflow limitation is a potential target for improving outcomes of older patients with asthma. The research team completed a pilot randomized controlled trial (RCT) of an intervention that trains older adults with asthma to better perceive expiratory airway obstruction through feedback via peak expiratory flow (PEF) prediction and couples this feedback with motivational interviewing (MI) to promote change in asthma self-management behaviors. Compared to an attention control, the intervention improved PEF, perception of airflow limitation and asthma control. In this project, the research team will conduct a fully powered RCT to test the intervention's efficacy among 300 adults ages ≥60 years with uncontrolled asthma who are on controller medications (daily maintenance or as needed) recruited from underserved inner-city medical practices in New York City. Patients will be randomized to the intervention or a time and attention matched educational control. The intervention and control will be delivered in 3 sessions over 6 weeks. The study will test the impact of the intervention on perception of expiratory airflow limitation in older adults with asthma, examine the efficacy of the intervention for improvements in lung function (PEF), self-reported asthma control (Asthma Control Questionnaire [ACQ] scores), quality of life (Asthma Quality of Life Questionnaire [AQLQ] scores), and emergency department and hospital use, and test the intervention's impact on mean daily ICS dose used (daily maintenance and as needed). Data will be collected at baseline, 1-month, 6-months (primary analyses of effectiveness) and 12-months post-intervention. In secondary analyses, the research team will test the sustainability of treatment effects with vs. without the booster treatment session (active booster vs. attention control booster) delivered immediately after the 6-month assessment on outcomes at 12-months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Research Coordinators conducting interviews and all investigators will be blinded to treatment allocation. Project staff will be assigned as Care Coaches for the intervention and the control treatments.
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 60 years
- •English or Spanish speaking
- •Self-report or physician diagnosis of asthma >1 year ago
- •Uncontrolled asthma
排除标准
- •Chronic obstructive pulmonary disease (COPD), or other chronic respiratory illnesses,
- •Congestive Heart Failure (CHF, New York Heart Association [NYHA] stages 4-5)
- •Cigarette smoking >15 packs-years
研究组 & 干预措施
PEF group with active booster
This arm will have 3 intervention sessions over 6 weeks and an additional (active) session at 6-month time point.
干预措施: PEF Interventional Session (Behavioral)
PEF group with active booster
This arm will have 3 intervention sessions over 6 weeks and an additional (active) session at 6-month time point.
干预措施: Active booster (Behavioral)
PEF group with control booster
This arm will have 3 intervention sessions over 6 weeks and a control booster session at the 6-month time point.
干预措施: PEF Interventional Session (Behavioral)
PEF group with control booster
This arm will have 3 intervention sessions over 6 weeks and a control booster session at the 6-month time point.
干预措施: Control Booster (Behavioral)
Control Group
This arm will have 3 control sessions over 6 weeks and a control booster session at 6-month time point.
干预措施: Control Sessions (Behavioral)
Control Group
This arm will have 3 control sessions over 6 weeks and a control booster session at 6-month time point.
干预措施: Control Booster (Behavioral)
结局指标
主要结局
Peak expiratory flow (PEF) Values
时间窗: at baseline, 1-month, 6-months, and 12-months post-intervention
Perception accuracy of airflow limitation will be measured by perceived and actual PEF values.
Mean daily ICS dose used
时间窗: at baseline, 1-month, 6-months, and 12-months post-intervention
Mean daily ICS dose will be recorded for asthma medications
次要结局
- Number of participants using medications on ≥70% of days prescribed(at baseline, 1-month, 6-months, and 12-months post-intervention)
- Participant personal best PEF percent(at baseline, 1-month, 6-months, and 12-months post-intervention)
- Asthma Control Questionnaire [ACQ] scores(at baseline, 1-month, 6-months, and 12-months post-intervention)
- Asthma Quality of Life Questionnaire [AQLQ] scores(at baseline, 1-month, 6-months, and 12-months post-intervention)
研究者
Juan Wisnivesky
Division Chief, General Internal Medicine
Icahn School of Medicine at Mount Sinai
