Technology-assisted, In-home Remote Patient Monitoring, Telemedicine, and Home-based Health Care for Treatment of Bone Marrow Transplant Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of patients without infection
研究概览
简要总结
This study is designed to assess the potential for successfully using technology-assisted in-home oncology care, including remote patient monitoring (RPM), telemedicine, and home-based health care services to support improved care management and appropriate referral to treatment for bone marrow transplant (BMT) patients.
详细描述
Study participants will complete an onboarding session into the Oncology at Home care program prior to discharge from the hospital. During the onboarding process, participants will be introduced to the RC care team, confirm understanding of their customized care plan treatment and goals as established by their BMT care provider, will receive an oral thermometer for use during the study, and will complete patient education. Working with the study team and RC RN, participants will receive, affix, activate, and test a wearable RPM device (the BioIntellisense BioSticker) prior to discharge from the BMT unit. As the BioSticker needs to be replaced every 30 days, patients will also receive three additional BioStickers new in packaging for use during months 2 and 3 as well as to have a back-up device in case of malfunction. Patients will return the BioSticker to BioIntelliSense with the postage paid return envelope provided at discharge.
The BioSticker will report skin temperature data once per hour, along with additional vital sign information (heart rate, respiratory rate, estimated body temperature, frequency of severe cough episodes, activity level, body position, sleep duration, degree of incline while sleeping, step count, step symmetry, step strength, and on/off body times). Participants will be expected to wear the BioSticker 24 hours per day, 7 days per week, and to also track and log their temperature manually with the oral thermometer according to usual care practice at a minimum of twice per day.
RPM data will be monitored 24 hours per day, 7 days per week by Reimagine Care, Inc. Advanced Practice Providers (APPs) from the Reimagine Care, Inc. Virtual Care Center (VCC). During daytime business hours, APPs will monitor in real time from the VCC. After business hours and on weekends, APPs will be on call and will be automatically notified through a mobile device in case of elevated temperature or other alert of interest. APPs on call will keep the notification device with them at all times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years to 89 years old
- •Bone marrow transplant recipients (allogeneic)
- •Determined by care provider to be stable for discharge to home setting for outpatient care according to clinical practice standard operating procedures (SOPs)
- •Residing in the Denver metro area for the duration of the study within 45 minutes of the AMC
- •Has in-home caregiver support 24/7 (i.e., does not live alone)
- •Has reliable telephone and home internet service and stable wireless network
- •Patient has agreed to not submerge the BioSticker device in more than 3 feet of water or submerge for longer than 30 minutes at a time.
- •Patient owns or possesses, as the primary user with reliable daily access, a mobile device (iOS or Android) capable of running the study's mobile application and accepting the terms and conditions
- •Patient is willing to complete a self-check temperature log to comply and be available for the duration of the study
- •Has access to reliable transportation to the hospital 24/7
排除标准
- •Patients will be excluded from study participation if the PI or designated care provider believes study participation would not be in the patient's best interest for clinical reasons.
结局指标
主要结局
Number of patients without infection
时间窗: Up to 90 days
Number of patients managed at home while using device who did not have an infection. This measure is collected for comparison with alerts. The device does not prevent infection.
Number of alerts detected through RPM
时间窗: Up to 90 days
Alert frequency is tracked to evaluate device function for feasibility of use in the clinical workflow. Patient treatment is not alert-based and is dependent on independent clinical confirmation. An alert of interest is defined as any of the following: * Oral temperature greater than or equal to 100.4 F (38.0 C) for 1 hour or one reading of 101 F (38.33C); * Mean skin temperature over 1 hour \> 98.5 F (36.9 C) or 2.5 times standard deviation from patient's baseline over 1 hour; * Mean heart rate over 1 hour \> 120 beats per minute or 30% overpatient's baseline over 1 hour * Mean respiratory rate over 1 hour \> 24 breaths per minute or 30% over patient's baseline over 1 hour, does not return to baseline following exertion; * The "BioIntelliSense Infection-Like AlertSymptoms" alert will also be monitored.
Number of patients with infection, but without need for hospitalization
时间窗: Up to 90 days
Number with infection, without hospitalization, while using device, for comparison with alerts.
Number of patients with infection, with need for hospitalization
时间窗: Up to 90 days
Number with infection, with hospitalization, while using device, for comparison with alerts.
次要结局
- Transplant Evaluation Rating Scale (TERS)(Baseline)
- Patient satisfaction: Functional Assessment of Cancer Treatment - Blood/Marrow Transplant (FACT-BMT)(Day 30, Day 90)
- Patient satisfaction: Functional Assessment of Cancer Therapy-General (FACT-G)(Baseline)