Integrating Electronic Patient Reported Biometric Measures (ePReBMs) From ADAMM-RSM in Respiratory Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Length of time wearing device (days)
研究概览
简要总结
Lung diseases are one of the most common causes of emergency room visits. There are very few tools that are able to predict which patients will have a worsening or increasing severity of their condition. There are also limited ways to check the health of patients with respiratory conditions at home and during the time between medical appointments.
The ADAMM-RSMTM device records heart rate, breathing rate, temperature, cough and activity while wearing it. This study will test participants willingness to wear the device and perform ongoing monitoring to assess the possibility to predict the onset and increases in severity of their lung conditions.
详细描述
The project will aim to create the infrastructure to collect clinical data and participants reported biometric measures (ePReBMs) from wearable devices in a database, and to run a pilot phase with a limited number of participants. During this phase, the feasibility of a long-term (6 months) home monitoring of respiratory parameters with the wearable device ADAMM-RSM (Health Care Originals, Rochester, NY, USA) will be tested, in parallel with the standard of care, in a limited number of participants with progressive fibrosing interstitial disease (PF-ILD) including idiopathic pulmonary fibrosis (IPF), lung transplant, cystic fibrosis (CF) and bronchiectasis, and tuberculosis (TB). The study design will test the possibility to collect data from ADAMM-RSM: ideally, the participants should wear the ADAMM-RSM every day, for at least 8 hours. For the purpose of this study, the investigators will aim to collect data from the device for every participant at least 3 days per week, at least 8 hours per day, for a period of 6 months.
The duration of this study is estimated in 2 years, including the data analysis. The participants will be provided the due information about the study and they will sign a written consent before enrolment (a copy is attached to the application to the Research Ethics Office of the University of Alberta).
Every participant enrolled in the study will be asked to wear the ADAMM-RSM (Health Care Originals, Rochester, NY, USA) device every day for 6 months.
The wearable device includes a non-invasive biosensor and processor that is attached to the surface of the skin using an adhesive sticker. It is designed to measure physical activity, heart rate, respiration, skin temperature, and cough metrics using embedded audio transducers, thermistor, accelerometer, gyroscope, and magnetometer. It can be applied anywhere on the chest, with a single-use, changeable sticker. As such, the device is able to collect heart and respiratory rate, temperature and cough, and to correlate these parameters to rest, activity and intensity of activity for the duration of the battery (18 hours). After signing the informed consent, the participants will be instructed on how to apply and to remove the device on/from the chest, to use the device during the day, and to recharge it at night using its dedicated charger.
Every device is supplied with a unique anonymous identifier, and will transmit the data via Wi-Fi to a cloud secured database provided by Health Care Originals (Health Care Originals, Rochester, NY, USA). This database will be physically located in a server within the Canadian borders. The database will be moved to a secured server at the University of Alberta at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with PF-ILD (including IPF), lung transplant, CF, bronchiectasis or TB must meet all of the following criteria to be enrolled in the study:
- •Male or female volunteers, at least 18 years of age at the time of screening visit;
- •Fluent in English and able to follow the instructions to use the ADAMM-RSM™;
- •Willing and cognitively able to sign informed consent
排除标准
- •Patients must be excluded from participation in this study if any of the following criteria are met:
- •History of active (clinically significant) skin disorders;
- •History of allergic response to silicones or adhesives;
- •Subjects with electronic implants of any kind (e.g. pacemaker);
- •Broken, damaged or irritated skin or rashes near the sensor application sites;
- •Subjects who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator.
结局指标
主要结局
Length of time wearing device (days)
时间窗: 6 month duration per participant
Total length of time participant wears device
次要结局
- Prediction of respiratory exacerbations- Number of emergency room visits(6 month duration per participant)
- Prediction of respiratory exacerbations- Number of hospital admissions(6 month duration per participant)