Managing Diagnosed COPD Patients Through Connected Devices to Provide Pulmonologists With Objective Data to Inform Treatment Decisions and Enable Exacerbation Intervention
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Exacerbation of COPD episodes by Assessment Test (CAT) scores Changes
研究概览
简要总结
This study is a device study that will use a double-arm. It will integrate the ANNE ONE platform which continuously tracks enrolled COPD patients' vital signs and symptoms over the course of the study and digitally shares that data with providers for clinical interpretation, potential intervention and treatment decision making and will help evaluate the impact on participating patient's COPD Assessment Test (CAT) scores. Subjects will be recruited from Emory clinics and identified via a data pull based on clinical relevant codes. Letters will be sent out to eligible candidates and interested participants will contact the research team. The research team will consent them over the phone and mail the device to them; participants will be compensated.
详细描述
Chronic obstructive pulmonary disease (COPD) is a diseases that causes airflow limitation and breathing-related problems, affecting approximately 16 million people in the U.S., most of which are aged 40 and above with a history of smoking. COPD causes acute exacerbations where a patient has worsening symptoms (increased shortness of breath, cough, or sputum production). Managing COPD presents many challenges, as patients struggle to adhere to their prescribed treatment plans. Digital platforms are gradually becoming more available to enable providers to help patients manage their condition. These platforms create objective transparency, lessening the need for patients to consciously track their COPD exacerbation events, enabling providers to proactively manage their patients' condition, and creating actionable reports for providers to review with their patients. Ultimately, connected devices present a strong opportunity to provide patients with appropriate care earlier in the patient journey, while enabling pulmonologists to deliver more customized management based on close to real time objective data.
The primary goal of this study is to evaluate the impact of the implementation of the ANNE ONE platform on patients with COPD's condition. This will be achieved by using the ANNE ONE platform to continuously track enrolled COPD patients' vital signs over the course of the study and digitally sharing that data with providers for clinical interpretation, potential intervention and treatment decision making. Interviews have been conducted with leading pulmonologists and staff at Emory Healthcare to understand what factors are considered when recommending a treatment pathway for a COPD patient, what the current workflow shortcomings are and how a new workflow using the ANNE ONE platform could effectively be integrated at a pulmonologist's office.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 40>years
- •Have a formal diagnosis of COPD
- •Must be able to understand and speak English in order to complete the survey questionnaires.
- •They must be able and willing to download the ANNE ONE application on a smartphone.
- •Have their COPD managed by a pulmonologist.
- •Have the willingness and ability to commit to the study period and completion of the surveys.
排除标准
- •Participants with a formal diagnosis of asthma will be excluded.
- •Those who are unable to read and/or speak English
- •Patients who exhibit physical or mental disability precluding the ability to provide informed consent will be excluded from the study.
- •Those who are unable or unwilling to download the ANNE ONE application will also be excluded.
- •Additionally, participant who are not willing or able to commit to the duration of the study will not be included.
结局指标
主要结局
Exacerbation of COPD episodes by Assessment Test (CAT) scores Changes
时间窗: At baseline and at 16 weeks
CRC will be responsible for collecting through patient-reported and electronic medical record (EMR)-reported (clinical notes and/or hospitalizations). Greater impact on COPD Assessment Test (CAT) scores (reduction of patient symptoms) compared to control group.
次要结局
- Vital data: SpO2 drop <90%(From baseline to study completion (16 weeks))
- Change in Patient Satisfaction Scores(Week 16)
- Number of Uncontrolled Flags(From baseline to study completion (16 weeks))
- Number of exacerbations onset detected(From baseline to study completion (16 weeks))
- Vital data: SpO2 drop >4%(From baseline to study completion (16 weeks))
- Vital data: FEV1(From baseline to study completion (16 weeks))
- Vital data: Respiratory Rate(From baseline to study completion (16 weeks))
- Number of Patient Emergency Visits(Week 16)
- Provider Satisfaction Scores(Week 16)
- Response to Flags(From baseline to study completion (16 weeks))