Digital Tools for Improved Awareness and Self-Management of Asthma in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 901
- 试验地点
- 1
- 主要终点
- Change in asthma-associated expenditures due to emergency department and hospital utilization
研究概览
简要总结
The Asthma Digital Study is a virtual, two-arm, randomized, controlled trial that will investigate the impact of digital tools on asthma symptom control, exacerbation frequency, healthcare utilization, and medical expenditures in adults with asthma.
详细描述
The Asthma Digital Study is a virtual, two-arm, randomized, controlled trial that will investigate the impact of digital tools on asthma symptom control, exacerbation frequency, healthcare utilization, and medical expenditures. Adults with asthma will be randomized to the passive or active arm in a 1:1 ratio.
All participants will be sent two devices, at no cost-an Apple Watch and a Beddit Sleep Monitor. These are publicly available, commercial devices that have not been modified for this study.
The study will be administered largely through a customized version of CareEvolution's MyDataHelps app (the "Study App"). Access to the Study App will be provided to all participants. It will be used to administer informed consent and electronic patient reported outcome (ePRO) measures, and for other study purposes. Only active arm participants will have access to Study App features designed to support asthma self-management. These features include "smart nudges" based on device data, symptom and trigger tracking, evidence-based education, summaries of health metrics gathered from the Apple Watch and Beddit Sleep Monitor, in-app medication refill resources, as well as other resources.
The study duration is 2 years. Participants can keep using the Study App and devices after Year 1, though this is not required. Primary analyses will utilize Year 1 data only. During Year 2, data collection will continue where available, though fewer data will be collected because use of digital tools is not required during Year 2, and health coverage changes may cause loss of access to claims data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Health insurance coverage through an Anthem, Inc. affiliate.
- •18-64 years of age
- •Resident of the United States for the duration of the study
- •Comfortable reading and writing in English
- •Owns an iPhone 6s or later
- •Has been diagnosed with asthma by a provider
- •1+ emergency department visit in the preceding 24 months with an associated asthma diagnosis, or a combination of factors that might be associated with uncontrolled asthma. Factors include:
- •History of asthma medication prescriptions
- •History of asthma-associated primary care visits
- •Diagnosis of chronic sinusitis, pharyngitis, influenza, allergic rhinitis, hypertension, diabetes, and/or obesity
- •History of smoking
- •Age and zip code
排除标准
- •Unable to sleep in a bed with a Beddit sleep monitor at least 5 nights per week on average (e.g., shift workers who experience limited or erratic night-time sleep schedule, frequent travelers unable to stably sleep on the sensor at the requisite rate)
- •Currently enrolled in any other asthma or pulmonary studies
- •Currently on any immunologic for asthma
- •Participated in a prior pilot study investigating the same digital tools
- •Member of an Anthem plan with annual incentives limits of $100 or less
- •Resident of Puerto Rico
- •Pregnancy
- •Diagnosis of any of the following:
- •Chronic Obstructive Pulmonary Disease/Emphysema
- •Cystic Fibrosis
- •Any malignancy other than a non-melanoma skin cancer
- •Any dementia diagnosis
- •Neurodegenerative diseases (e.g., Parkinson's)
- •Schizophrenia
- •Heart failure
- •On dialysis
- •Women who are postpartum, with delivery in the past 8 weeks
研究组 & 干预措施
Passive
Passive arm participants will be sent two devices, at no cost-an Apple Watch and a Beddit Sleep Monitor. These are commercially available and have not been modified for this study. Participants will be asked to use these devices regularly throughout study Year 1. Participants can optionally continue to use devices during Year 2, if they have met requirements during Year 1 to keep study devices. To be eligible to keep devices, participants must meet pre-specified levels of adherence to study procedures.
Access to the Study App will be provided to all participants. It will be used to administer informed consent and electronic patient reported outcome (ePRO) measures, and for other study purposes. However, passive participants will not have access to the Study App features designed to support asthma self-management.
Active
Active arm participants will be sent the same devices, also at no cost, and asked to use them in the same manner.
Only the active arm will have access to Study App features for asthma self-management, including:
- "Smart nudges" that may promote proactive asthma self-management
- Asthma symptom and trigger tracking
- Evidence-based asthma education
- The ability to photograph and easily reference an asthma action plan from a healthcare provider.
- A 90-day summary of self-reported asthma symptoms/triggers and device-recorded heart rate and respiratory rate. This summary can be shared with providers.
- In-app viewing of active asthma medications, refills available, and phone numbers to call for refills (subject to prescription benefits).
Active participants can, but are not required to, use the Study App in Year 2. Those who choose to may keep using study devices in Year 2, provided they meet requirements to keep devices. These requirements are the same for both arms.
干预措施: Digital Tools for Asthma Self-Management (Other)
结局指标
主要结局
Change in asthma-associated expenditures due to emergency department and hospital utilization
时间窗: 12 months before and after baseline
Sum of all allowed costs for emergency and hospital care, where asthma is specified as a diagnosis. Costs from the 12 months preceding baseline will be compared to costs from 12 months after baseline. Mean change in costs will be compared across arms.
Change from baseline in Asthma Control Test (ACT), a validated patient-reported outcome (PRO) measure of asthma symptom control
时间窗: Baseline and 12-month time points
ACT change among all participants with baseline ACT score suggesting that asthma may be uncontrolled (ACT score of 19 or lower). Mean ACT change will be compared across arms.
次要结局
- Readiness ruler, asthma self-management(Active arm only: 2 weeks and months 2, 4, 6, 8, 10, 12)
- Asthma Medication Ratio(Months 1-12; Months 13-24)
- Adherence to asthma medications(Months 1-12; Months 13-24)
- Frequency of unplanned visits for asthma care(Months 1-12; Months 13-24)
- Self-reported smoking and e-cigarette use(Baseline and month 12)
- Asthma-associated expenditures due to emergency department and hospital utilization(Months 13-24)
- Total Medical Expenditures(Months 1-12; Months 13-24)
- Total Asthma-Associated Expenditures(Months 1-12; Months 13-24)
- Adherence to Refills and Medications Scale, 7-item version (ARMS-7)(Active arm only: 2 weeks and months 2, 4, 6, 8, 10, 12)
- Work Productivity and Activity Impairment Questionnaire 2.0, asthma version(Active arm only: Baseline and months 1, 3, 5, 8, 12)
- Symptom-free days(Active arm only: Months 1-12)
- Change from baseline in Asthma Control Test (ACT), a validated patient-reported outcome (PRO) measure of asthma symptom control(Active arm only: Baseline and months 1, 2, 3, 4, 5, 6, 8, 10, 12)
- Health Confidence Score(Active arm only: Baseline and months 1, 3, 5, 8, 12)
- Frequency of prescriptions for oral corticosteroids(Months 1-12; Months 13-24)
- Study App Engagement Metrics(Active arm only: Months 1-12; Months 13-24)
- Rates of enrollment in pharmacy auto-refill and home delivery services(Months 1-12; Months 13-24)