A Pragmatic, Single-blind, Randomized Crossover Trial Testing the Effectiveness of Autonomous Remote Patient Peripheral Edema Monitoring and Reporting in HEART FailurE Compared to conventionaL remoTe Patient Monitoring.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 6
- 主要终点
- Heart Failure Events (HFEs, a composite of HFH or Worsening HF event without hospitalization (as defined in [1-Abraham])
研究概览
简要总结
This pragmatic randomized crossover trial looks at the effect(s) of using a remote patient monitoring device (Heartfelt device) with health alerts to monitor the development of peripheral edema in patients with heart failure (HF). The hypothesis is that this passive measurement method will lead to better data availability, which in turn will improve patient care and reduce hospitalizations for the management of worsening HF (HF hospitalizations, HFHs) in nonadherent participants with chronic HF. The study objectives are:
- Primary objective: Establish if the Heartfelt device is safe to use and effective at reducing HFHs.
- Secondary objectives:
- Establish the effect of the Heartfelt device on data availability compared to existing remote monitoring devices.
- Establish the effect of the Heartfelt device on HF clinical outcomes.
Participants will need to:
- Install the device in their home for at least a year and up to 4 additional years after.
- Reply to remote patient monitoring phone calls to follow the care plans.
详细描述
Participants will be recruited through Remote Patient Monitoring Providers (RPMPs) based in the US, using crossover randomization between standard care and Heartfelt device usage with health alerts sent to RPMPs. The RPMPs will follow a protocolized intervention when responding to raised alerts.
The study design is a crossover randomization between:
- Standard care (control), 162 days: The device is installed in the home and captures data but no health alerts are sent, and the RPMP does not receive data from the device. (Health alerts are generated and stored for review at the end of the study period to correlate with health issues which occurred during usual care).
- Standard care + Heartfelt (intervention), 162 days: The device captures data and transmits volume measurements and health alerts to the RPMP for review. RPMPs follow a pre-specified alert protocol, potentially following up with the patient.
At consent, patients get randomized to an install date over a period from 21 to 60 days following consent, subject to scheduling this at least 14 days after the most recent recorded hospital discharge at the time of consent, or the discharge from their current hospitalization if hospitalized at the time of consent.
Total study length is 366 days (days 0 to 365). There are two 21-day "washout" periods to prevent carryover between study arms. The first washout period extends from day 0-20 inclusive, and the second from day 183-203 inclusive
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants cannot be effectively blinded as they receive feedback from the RPMP in the intervention arm, and false alerts could alter the control arm's dynamics. The RPMP cannot be effectively blinded to study arms due to access to additional patient data (such as weighing scale data) to compare to any "fake" foot volume data that might be provided.
The focus of blinding is the Clinical Events Committee (CEC), which will adjudicate if events recorded in the EHR/Claims data count as outcome events. There is no reason for the CEC to have access to logs of contact with patients or data measured with the Heartfelt device. Prior to EHR/Claims data-derived data being provided to the CEC, it will be cleansed of any such potentially-unblinding data. This ensures unbiased outcome assessment, with the CEC not accessing device alert data.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form (wet or digital signature)
- •Male or female, aged 22 to [No maximum age]
- •Diagnosed with Chronic Heart failure at least 2 months prior to randomization
- •Documented history of peripheral edema (edema in feet and lower legs), defined as at least one clinical mention in the medical record indicative of oedema during prior clinical assessment.
- •Evidence of heart failure decompensation or elevated risk of future hospitalization, defined by one or more of the following:
- •a.Hospitalization for heart failure occurring at least once in the past 6 months or at least twice in the past 12 months; OR b.Receipt of intravenous/subcutaneous diuretic therapy for heart failure (inpatient or outpatient setting) occurring at least once in the past 6 months or at least twice in the past 12 months; OR c.Emergency department or urgent care visit for heart failure decompensation, occurring at least once in the past 6 months or at least twice in the past 12 months; OR d.Clinician assessment that the participant is at high risk of heart failure hospitalization within the next 6-12 months, based on documented recent clinical course (e.g. worsening congestion, escalating diuretic requirements, recurrent decompensation, and/or comorbidity burden).
- •Patients who are treated with daily diuretics.
- •Evidence of non-adherence defined by one or more of the following:
- •Participants with ≥180 days of historical monitoring/device data available
- •● Failure to collect ≥50% of expected days of prescribed home physiological monitoring data (e.g. weight, blood pressure, or other clinician-recommended measurements), assessed over a continuous 180-day period; OR
- •● Discontinuation from a remote patient monitoring/home monitoring program due to non-adherence; OR
- •● Failure to adhere to a prescribed home-based therapy/monitoring intervention, supported by device usage data showing <50% of expected days of use over a continuous 180-day period.
- •Participants without ≥180 days of historical monitoring/device data available: Evidence of non-adherence may be demonstrated by low data capture over shorter windows, defined as any of the following :
- •● ≤2 days of monitoring data recorded for each of the most recent 4 consecutive weeks during which any remote monitoring device was continuously available in the patient's home; OR
- •● ≤3 days of monitoring data recorded in any consecutive 8 week period period during which any remote monitoring device was continuously available in the patient home; AND/OR
- •by documented non-adherence in the medical record within the last 3 years:
- •Historical documentation of persistent medication and/or dietary non-adherence, defined as either a clear statement of ongoing non-adherence or ≥2 documented instances of non-adherence concerns (including dosing and/or timing, where available); OR
- •Historical documentation on repeated clinical assessments indicating persistent difficulty adhering to recommended self-management activities (e.g. repeated failure to follow monitoring instructions, incomplete engagement with care plan, or repeated non-attendance at scheduled reviews).
- •For participants not previously enrolled in RPM or without sufficient historical monitoring data, non-adherence will be assessed prospectively using connected scales provided at study initiation. Objective adherence metrics derived from scale usage during the initial monitoring period will be used both to characterise baseline adherence and to support predefined subgroup analyses.
- •Clinical teams/PIs discretion as patients being non-adherent.
- •For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 weeks after the end of the study.
- •Patients who are covered by an insurance plan that covers IDE-B costs (e.g. Medicare Part-B), OR written contract signed by the patient, or their provider or payor, stating that they will be liable for any trial-associated costs that Medicare would ordinarily cover if the patient were covered by Medicare.
- •1. Participant has bandages to lower limbs every day
- •Participant has an amputation of both feet
- •Participant is a regular wheelchair user inside their home
- •Participant is bed-bound
- •Participant is of no fixed abode
- •Participant is taking part in a conflicting evaluation/study that could confound the results of this evaluation and/or impact clinical interventions and participant outcomes
- •Participant is unable to take diuretics
- •Participant is on a regular schedule of dialysis
- •Participant has a history of recurrent leg or feet deep vein thrombosis (DVT) (two or more episodes within the last 12 months).
- •10. Participant has a history of recurrent leg or feet cellulitis episodes (two or more episodes within the last 12 months).
- •11. Participant is prescribed diltiazem or verapamil on an ongoing basis.
- •Participant is pregnant or is not taking medically approved birth control if of child-bearing potential.
排除标准
- 未提供
研究组 & 干预措施
Standard Care (control)
Device is installed and data is captured but volume measurements and health alerts are not transmitted to the RPMP.
干预措施: Heartfelt Device installed (Device)
Standard Care + Heartfelt (intervention)
Device is installed and data is captured, and volume measurements and health alerts are transmitted to the RPMP for review and potential follow-up (per a pre-specified alert protocol).
干预措施: Standard care (Other)
Standard Care + Heartfelt (intervention)
Device is installed and data is captured, and volume measurements and health alerts are transmitted to the RPMP for review and potential follow-up (per a pre-specified alert protocol).
干预措施: Heartfelt-guided care (Device)
Standard Care + Heartfelt (intervention)
Device is installed and data is captured, and volume measurements and health alerts are transmitted to the RPMP for review and potential follow-up (per a pre-specified alert protocol).
干预措施: Questionnaires (Other)
Standard Care (control)
Device is installed and data is captured but volume measurements and health alerts are not transmitted to the RPMP.
干预措施: Standard care (Other)
Standard Care + Heartfelt (intervention)
Device is installed and data is captured, and volume measurements and health alerts are transmitted to the RPMP for review and potential follow-up (per a pre-specified alert protocol).
干预措施: Heartfelt Device installed (Device)
Standard Care (control)
Device is installed and data is captured but volume measurements and health alerts are not transmitted to the RPMP.
干预措施: Questionnaires (Other)
结局指标
主要结局
Heart Failure Events (HFEs, a composite of HFH or Worsening HF event without hospitalization (as defined in [1-Abraham])
时间窗: 12 months, plus up to 48 months long term follow-up
Used to demonstrate whether the device effectively reduces HFHs and urgent HF visits.
Doubling in serum creatinine (sCr) from baseline with at least 2.0mg/dL
时间窗: 12 months, plus up to 48 months long term follow-up
Used to ensure that increased diuretic treatment following alerts from the device does not lead to significant increase in AKI
次要结局
- Difference in data availability (device generated or contemporaneous self-report)(12 months, plus up to 48 months long term follow-up)
- The date and length (in hours) of hospital admission and re-admissions(12 months, plus up to 48 months long term follow-up)
- Cause of hospitalizations (HF or non-HF)(12 months, plus up to 48 months long term follow-up)
- Date of increase in HF medications when the patient is home or in the community (not the detailed changes whilst on the ward)(12 months, plus up to 48 months long term follow-up)
- Death and cause of death from the clinical record (HF or non-HF as defined in [1-Abraham])(12 months, plus up to 48 months long term follow-up)
- Loss of independence (patient unable to live at home; for example, relocation to a care facility for an indefinite duration)(12 months, plus up to 48 months long term follow-up)
- Route of admission for hospitalization events (ICU, CCU, or ward admission),and discharge (home, skilled nursing facility and long term care facility).(12 months, plus up to 48 months long term follow-up)
- Scheduling of care events (scheduled or unscheduled)(12 months, plus up to 48 months long term follow-up)
- The setting of care events (inpatient or outpatient)(12 months, plus up to 48 months long term follow-up)
- Date and time of health alerts generated by the Heartfelt device(12 months, plus up to 48 months long term follow-up)
- Date, time and method of contact made following reception of a health alert generated by the Heartfelt device(12 months, plus up to 48 months long term follow-up)
- Date and reason for study withdrawal(12 months, plus up to 48 months long term follow-up)