The Use of the Propeller Health Platform to Improve Inhaled Corticosteroid (ICS) Use Among Adults With Uncontrolled Persistent Asthma (Propeller Health)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Short Acting Bronchodilator Medication use in Group with Propeller Health Platform Digital Technology Turned On vs Group with Propeller Health Platform Digital Technology Turned Off
研究概览
简要总结
This is a behavioral randomized controlled trial of adults with uncontrolled persistent asthma that tests if the Propeller Health sensor, mobile application, and dashboard can improve adherence to ICS.
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
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Under the care of a staff asthma physician (i.e. pulmonologist or allergist/immunologist) at NorthShore University HealthSystem (NS)
- •Have an active NorthShore Connect (patient portal) account
- •Persistent uncontrolled asthma in the past 12 months
- •Active prescription for daily ICS medication for asthma
排除标准
- •candidate refusal
- •the presence of other co-morbidities (e.g. severe psychiatric disorder) that could interfere with study participation
研究组 & 干预措施
Intervention Group
The components of the intervention unique to the treatment group include: 1) access to the Propeller Health Asthma App on his/her phone, which includes tracking of ICS and SABA usage; 2) receipt of NorthShore Connect physician alerts (these will be sent by the asthma nurse on behalf of the NS physician) if he/she has "poor adherence" ie missed 4 consecutive days of all of his/her controller medication dosages and their sensor has sent heartbeat to application OR "at risk" alerts if a patient transitions to a "not well controlled" or "poorly controlled" status (defined by the NHLBI guidelines); and 3) monthly phone calls with a nurse from his/her asthma doctor's office to review ICS and SABA usage reports (provided by Propeller Health on their Propeller Health dashboard).
干预措施: Electronic Medication Monitors on ICS and SABA - Active Mode (Behavioral)
Intervention Group
The components of the intervention unique to the treatment group include: 1) access to the Propeller Health Asthma App on his/her phone, which includes tracking of ICS and SABA usage; 2) receipt of NorthShore Connect physician alerts (these will be sent by the asthma nurse on behalf of the NS physician) if he/she has "poor adherence" ie missed 4 consecutive days of all of his/her controller medication dosages and their sensor has sent heartbeat to application OR "at risk" alerts if a patient transitions to a "not well controlled" or "poorly controlled" status (defined by the NHLBI guidelines); and 3) monthly phone calls with a nurse from his/her asthma doctor's office to review ICS and SABA usage reports (provided by Propeller Health on their Propeller Health dashboard).
干预措施: Asthma App Tracking of ICS/SABA Usage - Active Mode (Behavioral)
Intervention Group
The components of the intervention unique to the treatment group include: 1) access to the Propeller Health Asthma App on his/her phone, which includes tracking of ICS and SABA usage; 2) receipt of NorthShore Connect physician alerts (these will be sent by the asthma nurse on behalf of the NS physician) if he/she has "poor adherence" ie missed 4 consecutive days of all of his/her controller medication dosages and their sensor has sent heartbeat to application OR "at risk" alerts if a patient transitions to a "not well controlled" or "poorly controlled" status (defined by the NHLBI guidelines); and 3) monthly phone calls with a nurse from his/her asthma doctor's office to review ICS and SABA usage reports (provided by Propeller Health on their Propeller Health dashboard).
干预措施: NorthShore Connect Real Time ICS and SABA Usage Feedback - Yes (Behavioral)
Intervention Group
The components of the intervention unique to the treatment group include: 1) access to the Propeller Health Asthma App on his/her phone, which includes tracking of ICS and SABA usage; 2) receipt of NorthShore Connect physician alerts (these will be sent by the asthma nurse on behalf of the NS physician) if he/she has "poor adherence" ie missed 4 consecutive days of all of his/her controller medication dosages and their sensor has sent heartbeat to application OR "at risk" alerts if a patient transitions to a "not well controlled" or "poorly controlled" status (defined by the NHLBI guidelines); and 3) monthly phone calls with a nurse from his/her asthma doctor's office to review ICS and SABA usage reports (provided by Propeller Health on their Propeller Health dashboard).
干预措施: Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - Yes (Behavioral)
Control Group
The control group will not receive access to view the contents of the Propeller Health Asthma App on his/her phone, NorthShore Connect alerts for missing ICS or overuse of SABA, or for his/her asthma doctor (the asthma nurse will be viewing this information on behalf of the asthma doctor) to view his/her ICS and SABA use on the Propeller Health dashboard until after the 3-month study has been completed.
干预措施: Electronic Medication Monitors on ICS and SABA - Silent Mode (Behavioral)
Control Group
The control group will not receive access to view the contents of the Propeller Health Asthma App on his/her phone, NorthShore Connect alerts for missing ICS or overuse of SABA, or for his/her asthma doctor (the asthma nurse will be viewing this information on behalf of the asthma doctor) to view his/her ICS and SABA use on the Propeller Health dashboard until after the 3-month study has been completed.
干预措施: Asthma App Tracking of ICS/SABA Usage - Silent Mode (Behavioral)
Control Group
The control group will not receive access to view the contents of the Propeller Health Asthma App on his/her phone, NorthShore Connect alerts for missing ICS or overuse of SABA, or for his/her asthma doctor (the asthma nurse will be viewing this information on behalf of the asthma doctor) to view his/her ICS and SABA use on the Propeller Health dashboard until after the 3-month study has been completed.
干预措施: NorthShore Connect Real Time ICS and SABA Usage Feedback - No (Behavioral)
Control Group
The control group will not receive access to view the contents of the Propeller Health Asthma App on his/her phone, NorthShore Connect alerts for missing ICS or overuse of SABA, or for his/her asthma doctor (the asthma nurse will be viewing this information on behalf of the asthma doctor) to view his/her ICS and SABA use on the Propeller Health dashboard until after the 3-month study has been completed.
干预措施: Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - No (Behavioral)
结局指标
主要结局
Change in Short Acting Bronchodilator Medication use in Group with Propeller Health Platform Digital Technology Turned On vs Group with Propeller Health Platform Digital Technology Turned Off
时间窗: 3.5 months
Use of the Propeller Health Platform in the treatment group in active mode, compared to the attention control group in silent mode, will demonstrate a 20% change in SABA use and/or minimal clinically important difference (three points) change on the ACT and/or change from ACT score ≤ 19 to ≥20, at 3-months. The 20% change in SABA use = 20 point change (e.g. if a participants uses SABA 40% of days over the 2 week run-in period, and they change SABA use to 20% of days during the final 14 days of the active treatment period, that will equal a 20 point change. If SABA use changes from 40% of days over the 2- week run-in period to 32% of days during the final 14 days of the active treatment period, this will not be considered a 20 point change).
次要结局
- Participant and clinician satisfaction as assessed by brief post-study survey of Propeller Health Platform Digital Technology(3.5 months)
- Inhaled Corticosteroid Medication taking Behavior in the Group using Propeller Health Platform Digital Technology Turned On vs Group using Propeller Health Platform Digital Technology Turned Off(3 months)
研究者
Giselle Mosnaim
Principal Investigator
NorthShore University HealthSystem