Usability and Utility Assessment of Passive Remote Monitoring of Multiple Novel Indicators of Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Myia Platform feasibility: questionnaire
研究概览
简要总结
This study is intended to evaluate the impact of passive continuous remote patient monitoring to assist in the outpatient management of heart failure (HF) patients.
详细描述
The study will prospectively evaluate the usability, utility, and efficacy of remote monitoring using novel noninvasive technologies in HF patients in an outpatient setting. Investigators will gather dynamic, longitudinal data from multiple sensors, in addition to patient-reported and physician-reported data. Both the patient interface through interactions with the sensors and mobile application, and the clinician interface through the monitoring portal, will be evaluated for usability, utility and efficacy.
Patients will be recruited for the study from the Barnes Jewish Hospital Advanced Heart Failure Clinic. Eligible individuals will receive onboarding instructions and a study schedule detailing the required surveys and clinical activities they will be asked to complete over a period of 7 months. In addition to onboarding instructions and a study schedule, individuals will have the kit of sensors shipped to their home.
After the Myia Home Hub and Myia Sensor Suite are set up, data will begin to be transmitted. Following a run in period where data is collected and delivered but not acted upon by clinicians all eligible participants will move forward with 6 month interactive study monitoring.
In addition to obtaining questionnaires and using the devices in the Myia kit, participants will also be asked to obtain their blood pressure and weight daily.
During the course of the study, outpatient health status data for the group will be collected, summarized and delivered to clinicians in an electronic dashboard. The format and content of the data dashboard will be updated based on user feedback throughout the study. Required changes deemed appropriate by the healthcare team will be incorporated into the software platform alongside any standard updates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Outpatients cared for by BJH Advanced Heart Failure Clinic, where BJH is their primary cardiology care team
- •Age ≥ 18 years old at time of consent
- •HFrEF diagnosis in the BJH Advanced Heart Failure Clinic medical record
- •Has had an ER presentation or hospitalization related to their heart failure in last 12 months prior to enrollment
- •Most recent recorded Left Ventricular Ejection Fraction (LVEF) of < 50% and at least 1 recorded LVEF of < 40%
- •Scheduled clinic visit 90- 180 days after study enrollment.
- •NYHA Class II-IV
- •Sleeps in the same bed at ≥ 4 days per week
- •Able to ambulate
- •Willingness to complete the required surveys, measurements and study activities
排除标准
- •Current ventricular assist device or cardiac transplant.
- •Currently listed for cardiac transplantation
- •End-Stage Renal Disease on chronic dialysis
- •Malignancy diagnosis undergoing active treatment
- •Hospice or palliative care
- •Living in a skilled nursing facility or other chronic care facility (ambulatory patients only)
- •Self-reported pregnancy or planned pregnancy in the next 6 months
- •Inability or unwillingness to consent and/or follow requirements of the study
- •Planned major surgeries or procedures requiring hospitalization in next 6 months
- •Use of Lifevest or other worn device that may affect ballistocardiogram measurements
- •Patient weight > 385 lbs at time of enrollment
- •Life expectancy <1 year
结局指标
主要结局
Myia Platform feasibility: questionnaire
时间窗: From baseline to 6 months (final)
Patient perception of the Myia Platform will be assessed during the study using a structured questionnaire, delivered either electronically or by paper to patients by research staff. Patient Platform satisfaction/usability/utility questionnaire: The formal title of the questionnaire is 'Check In Survey' and it consists of 17 questions with scaled options, 1-7 (1=most positive, 7=most negative) and it is administered at 3 time points. The lower the overall total the more positive the patient rating of the Myia Platform.
次要结局
- Medication management: total number of medication changes(From baseline to 6 months time (final))
- Persistence of greater than 1 data point per week data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure.(From baseline to 6 months time (final))
- Medication management: length of time to medication change(From baseline to 6 months time (final))
- Persistence of minimally useful data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure.(From baseline to 6 months time (final))
- Persistence of daily data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure.(From baseline to 6 months time (final))
- Medication management: target dose(From baseline to 6 months time (final))
- Persistence of weekly data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure.(From baseline to 6 months time (final))
- Persistence of vital sign data acquisition of a remote patient monitoring platform to monitor the health status of patients living with heart failure.(From baseline to 6 months time (final))