Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Asthma Control Test
研究概览
简要总结
This study will evaluate the role of using electronic sensors for asthma inhaler devices in monitoring medication adherence and asthma control
详细描述
This study will assess the feasibility of using electronic sensors for asthma inhalers in a population of urban minority adults and children with moderate-severe asthma in the Bronx.
Investigators will also assess differences in asthma outcomes (specifically asthma control as a primary outcome measure) and treatment adherence in a group of participants with moderate-severe asthma who use inhalers with electronic sensors and real-time remote outreach worker monitoring/feedback compared to a group of participants who use inhalers with electronic sensors but without real-time monitoring/feedback.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (>18 years) and children (5-11 years old) with a clinical history (i.e. physician-diagnosed) of asthma
- •Moderate to severe asthmatics with ≥1 asthma-related ED visits or hospitalizations in the past year
- •Use of daily controller inhaler medications
- •Adult non-smokers, or lifetime use <5 pack years with no smoking in last 1 yr
- •Smartphone required
- •English or Spanish speaking
排除标准
- •No smartphone
- •Use of oral corticosteroids in prior 4 weeks
- •Pregnancy
- •Psychiatric conditions
研究组 & 干预措施
Electronic sensor and OW education
MDI sensor-generated alerts will be relayed and responded to (e.g. outreach worker contacts the participant for a missed dose) in real-time to the intervention group. Outreach worker will also assess intervention group participants' need for further asthma education and provide asthma education over the phone
干预措施: Electronic sensor and OW education (Behavioral)
Usual Care
Usual care group will receive the electronic tracker but the sensor-generated alerts will not be delivered. If the usual care group rescue inhaler data reveals frequent use of rescue medication (daily use for >3 days) investigators will reach out (via app or phone call) to advise the participant to see their physician
结局指标
主要结局
Asthma Control Test
时间窗: change from baseline to 6 months
validated asthma control measure
次要结局
- Medication adherence(change from baseline to 6 months)
- Health care utilization(change from baseline to 6 months)
研究者
Marina Reznik
Associate Professor of Pediatrics
Montefiore Medical Center