Benefits of Microcor in Ambulatory Decompensated Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 157
- 主要终点
- Number of Data Updates Received by the uCor Subject Management System
研究概览
简要总结
To assess investigator engagement of μCor system data in the context of heart failure management. The μCor system includes a sensor and wearable patch for fluid management.
详细描述
Subjects meeting the inclusion/exclusion criteria will wear the μCor for up to 90 days.
During the study, face to face follow up will occur every 30 days. For all subjects, each scheduled clinic visit will include assessment of cardiac signs, symptoms, and any relevant clinically actionable events.
The subject will be given a daily diary to track symptoms, hospital visits, medication changes, and all other heart failure related clinical events.
Weekly phone calls to the subject will be given throughout the duration of the study to remind the patient to use the subject diary and to collect and record heart failure related clinical events.
The subject's health care provider team will receive the μCor data through access to a clinical tool interface. The clinical tool will send data updates that are dependent on the μCor data trends. The data updates will allow the health care provider team to take action when the data indicate worsening heart failure, within the context of standard of care medical practice and patient specific parameters. Weekly data reports will be delivered to the investigators.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •4.1.1 Subjects hospitalized for acute decompensated heart failure and enrolled in the study within 10 days post-hospital discharge.
- •4.1.2 Subjects who have had an acute heart failure event requiring medical management in the previous 180 days of index hospitalization admission. This acute heart failure event admission must be at least 2 weeks apart from the event admission in 4.1.1
- •4.1.3 Subjects 21 years of age or older on the day of screening.
排除标准
- •4.2.1 Subjects who are wearing the wearable cardioverter defibrillator (WCD)
- •4.2.2 Subjects not expected to survive one year from enrollment from non-cardiac disease.
- •4.2.3 Subjects with skin allergy or sensitivity to medical adhesives.
- •4.2.4 Subjects anticipated to start dialysis within 90 days.
- •4.2.5 Subjects currently implanted with an subcutaneous implantable cardio defibrillator (S-ICD) system.
- •4.2.6 Subjects who received a percutaneous coronary intervention (PCI) less than 24 hours after onset of heart failure related symptoms during index hospitalization.
- •4.2.7 Subjects who are unable to participate in all follow up visits.
- •4.2.8 Subjects participating in research other than a registry at the time of enrollment.
- •4.2.9 Subjects currently implanted with a Left Ventricular Assist Device (LVAD).
- •4.2.10 Subjects with self-reported pregnancy.
- •4.2.11 Subjects currently being actively managed with any device based remote HF monitoring.
结局指标
主要结局
Number of Data Updates Received by the uCor Subject Management System
时间窗: 90 days
Each time a subject's thoracic fluid index (TFI) exceeded a threshold for 3 consecutive days, a data update report was generated by the uCor management system. The site then confirmed its receipt of the data update by completing a case report form. At least 1 of these case report forms was completed for 56 subjects.
Approximate Time Spent Reviewing Data Reports Assessment Across Sites (PO 2: Part 1/2)
时间窗: 90 days
Sites reviewed data reports in each of the following contexts: planned weekly phone call, planned office visit, unplanned phone call, unplanned office visit, and data update. Sites reported whether they spent less than 5, 5 to 10, or greater than 10 minutes reviewing each report. At least 1 of these case report forms was completed for 214 subjects.
Approximate Time Spent Reviewing Data Reports Assessment Within Sites (PO 2: Part 2/2)
时间窗: 90 days
Sites reviewed data reports in each of the following contexts: planned weekly phone call, planned office visit, unplanned phone call, unplanned office visit, and data update. Sites reported whether they spent less than 5, 5 to 10, or greater than 10 minutes reviewing each report. At least 1 of these case report forms was completed for 214 subjects.
The Number of Medication Changes(MC) and Lifestyle Modifications(LS) Recommended to the Subject Based on Evaluating μCor Data and Symptoms (PO 3: Part 1/3)
时间窗: 90 days
Sites reviewed data reports in each of the following contexts: planned weekly phone call, planned office visit, unplanned phone call, unplanned office visit, and data update. In each context, the subject was asked whether their symptoms changed. If yes, the site reported in a case report form whether it took action to treat the subject in the form of a medication change or lifestyle modification. At least one of these case report forms (CRFs) was completed for 214 subjects
The Number of Medication Changes(MC) and Lifestyle Modifications(LS) Recommended to the Subject Based on Evaluating μCor Data and Symptoms (PO 3: Part 2/3)
时间窗: 90 days
Sites reviewed data reports in each of the following contexts: planned weekly phone call, planned office visit, unplanned phone call, unplanned office visit, and data update. In each context, the subject was asked whether their symptoms changed. If yes, the site reported in a case report form whether it took action to treat the subject in the form of a medication change or lifestyle modification. At least one of these case report forms (CRFs) was completed for 214 subjects.
The Number of Medication Changes(MC) and Lifestyle Modifications(LS) Recommended to the Subject Based on Evaluating μCor Data and Symptoms (PO 3: Part 3/3)
时间窗: 90 days
Sites reviewed data reports in each of the following contexts: planned weekly phone call, planned office visit, unplanned phone call, unplanned office visit, and data update. In each context, the subject was asked whether their symptoms changed. If yes, the site reported in a case report form whether it took action to treat the subject in the form of a medication change or lifestyle modification. At least one of these case report forms (CRFs) was completed for 214 subjects
The Number of Medication Changes Based on Subject Incidental Findings
时间窗: 90 days
During weekly planned phone calls, planned office visits, and unplanned office visits, sites asked subjects whether they underwent any changes to their heart failure and/or cardiac medications since the last phone call and reported the result in a case report form. At least 1 of these case report forms was completed for 241 subjects.
Number of Times High μCor Measurements Were Reduced Below Threshold Levels After Medication Was Titrated or Lifestyle Modifications Were Recommended
时间窗: 90 days
482 medication changes or lifestyle (MC/LS) modifications occurred within the first 90 days of the study. To include only medication changes preceded and followed by sufficient µCor data to determine a threshold crossing, medication changes within the first 2 weeks of the study or the final 3 weeks of device wear were discarded. This resulted in in 262 analyzable changes. Changes occurring within 1 week of another change were grouped together. This resulted in 192 change events. Time windows were defined as 0-13 days before the first change in a change event vs. 8-21 days after the last change in a change event. A high μCor measurement was defined as the receipt of a data update by the site. A low μCor measurement was defined as the absence of a data update received by the site.
次要结局
- Strength of Association Between μCor Measurements and Clinically Related Heart Failure Events.(90 days)
- Strength of Association Between μCor Measurements and Subject Reported Symptoms(90 days)
- Correlations Between uCor Measurements and Patient Reported Symptoms: Mild/Severe Symptoms(90 days)
- Hospital Readmission Rate, Physician Visit Rate, and Outpatient Clinic Visit Rate During the Study Period(90 days)
- Mortality Rate, Heart Failure Related Events, Quality of Life (QoL) and Healthcare Utilization Data at 6 Months and One Year Post Enrollment: Mortality Data(6 months and 1 year)
- Mortality Rate, Cause of Death, Quality of Life (QoL) and Healthcare Utilization Data at 6 Months and One Year Post Enrollment: Cause of Death(6 months and 1 year)
- Mortality Rate, Heart Failure Related Events, Quality of Life (QoL) and Healthcare Utilization Data at 6 Months and One Year Post Enrollment: Quality of Life Data(6 months and 1 year)
- Mortality Rate, Heart Failure Related Events, Quality of Life (QoL) and Healthcare Utilization Data at 6 Months and One Year Post Enrollment: Healthcare Utilization Data(6 months and 1 year)