MONITORED-HF: Remote MONIToring Of Ambulatory intRavEnous Diuretics in Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Response to device by carers
研究概览
简要总结
This study will aim to collect proof of concept data to inform the study design of a larger paired comparison study to establish key research questions about the Heartfelt device. The current study will be run with 2 parallel workstreams. Both are presented here:
Data collected from Work Stream 1 (WS1) is expected to give an indication of the usefulness of the volumes measured by the Heartfelt device in optimising diuretic therapy for patients undergoing ambulatory-IV diuretic treatment, as well as looking at the usefulness of foot volume changes monitoring post IV Diuretic treatment. As these patients are often managed in a home / community setting, objective indicators to assess oedema during treatment are currently limited.
Data collected from Work Stream 2 (WS2), patients recently discharged after a heart failure hospitalisation (HFH), is expected to determine if the Heartfelt device can be used to monitor heart failure stability and detect fluid overload in patients recently discharged from hospital after an episode of decompensated heart failure. The investigators may also be able to get an indication of the number of days prior to hospital admission during which the Heartfelt device can detect changes in foot volume.
Both workstreams will provide qualitative feedback, from health care practitioners, patients and carers in both groups about their experience using the Heartfelt Device.
详细描述
Heart failure hospitalisations are common, but some are potentially preventable through early detection and timely optimisation of pharmacotherapies, most often diuretic titration.
Peripheral oedema is a cardinal feature of heart failure decompensation, though not all patients seek medical attention at this time. The detection of this increase in volume may therefore be a useful tool in preventing heart failure decompensation and hospitalisation.
This study will evaluate a completely automated (no contact) device which captures volumes of the patient's feet in their home, with the ultimate aim of this data being accessible to the heart failure team. However for the purpose of this study, the clinical team will be blinded to the data in order to be able to assess the temporal relationship (and time) between an alert being generated by the device and a hospital admission, or medication change. However if for example a patient fall is detected by the device, a designated Manchester clinician can be contacted to act.
Peripheral oedema is a cardinal feature of heart failure decompensation, though not all patients seek medical attention at this time. The detection of this increase in volume may therefore be a useful tool in preventing heart failure decompensation and hospitalisation.
In WS1 of the current study, the investigators will specifically be looking at whether the use of the Heartfelt Technology can be used to support the remote monitoring of clinical response to home-based intravenous(IV) diuretic interventions as part of an admission avoidance strategy. Our hypothesis is that the Heartfelt technology coupled with this home intervention could provide clinically useful objective measurement of peripheral oedema, which could be used by the heart failure team to titrate the diuretics and guide duration of treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Work stream 1 Inclusion Criteria:
- •Patient is willing and able to provide written informed consent.
- •Diagnosis of heart failure
- •Patient with peripheral oedema requiring IV diuretics
- •Patient accepted for co-management by the MFT Heart Failure and home IV team*
- •There may be some instances where the patient is under the management of the MFT HF team but attends the day unit for IVs due to capacity or other logistical considerations. These patients can also be enrolled in the evaluation.
- •Work stream 1
排除标准
- •Patient has bandages to lower limbs everyday
- •Patient has an amputation of the foot
- •Patient lacks capacity to consent
- •Patient is not ambulant or unable to mobilise unaided around the house
- •Patient is of no fixed abode
- •Patient has potentially reversible cause of decompensated heart failure and is awaiting intervention (revascularisation/ valvular intervention)
- •Patient taking part in a conflicting evaluation/study that could confound the results of this evaluation by and/or impact clinical interventions and patient outcomes
- •Patient must not be pregnant, and is taking relevant birth control if of child-bearing potential*
- •Note that a patient not able to comply with daily weights is NOT an exclusion criteria as the Heartfelt Device should provide data for these patients despite their lack of ability to adhere to the usual monitoring protocol.
- •*Note that criteria (h) has been requested by the insurance for clinical trial cover. However we do not expect participants of this study to be trying to get pregnant (the typical age of patients is expected in an earlier evaluation was around 70 years ).
- •Work stream 2 Inclusion Criteria:
- •Patient is willing and able to provide written informed consent.
- •Diagnosis of heart failure
- •Patient under follow up with the MFT HF service
- •Patient with a recent admission with decompensated heart failure in last 12 months OR who received home IV diuretics within the last 12-months
- •Patient has been discharged on at least furosemide 80mg or equivalent diuretic dose
- •Work stream 2 Exclusion Criteria:
- •Patient has bandages everyday
- •Patient has an amputation of the foot
- •Patient lacks capacity to consent
- •Patient is not ambulant or unable to mobilise unaided around the house
- •Patient is of no fixed abode
- •Patient has potentially reversible cause of decompensated heart failure and is awaiting intervention (revascularisation/ valvular intervention)
- •Patient taking part in a conflicting evaluation/study that could confound the results of this evaluation by increasing clinic workload burden for that patient and/or impact clinical interventions and patient outcomes
- •Patient must not be pregnant, and is taking relevant birth control if of child-bearing potential*
- •Note that a patient not able to comply with daily weights is NOT an exclusion criteria as the Heartfelt Device should provide data for these patients despite their inability to use weighing scales at times.
- •*Note that criteria (h) has been requested by the insurance for clinical trial cover. However we do not expect participants of this study to be trying to get pregnant (the typical age of patients is expected in an earlier evaluation was around 70 years).
研究组 & 干预措施
Work Stream 1 (WS1)
The general aim of this work stream is to assess the hypothesis "can the volumes measured by the Heartfelt device be useful in titrating and optimising drug management for patients undergoing home-IV diuretics and after completion of IV-diuretic treatment.?"
We will characterise the data collected by the Heartfelt device in the participants' home, correlating it to weight readings (either from the scales or paper weight diary) and medical observations recorded while patients are being treated with IV Diuretics.
Patients from WS1 will be invited to keep the device in their home for 3 months in total, which will therefore cover periods during which they do not receive IV diuretics, but are still at relatively high risk of decompensation. That data will be analysed in the same fashion as the data collected in WS2.
干预措施: Heartfelt Device (Device)
Work Stream 1 (WS1)
The general aim of this work stream is to assess the hypothesis "can the volumes measured by the Heartfelt device be useful in titrating and optimising drug management for patients undergoing home-IV diuretics and after completion of IV-diuretic treatment.?"
We will characterise the data collected by the Heartfelt device in the participants' home, correlating it to weight readings (either from the scales or paper weight diary) and medical observations recorded while patients are being treated with IV Diuretics.
Patients from WS1 will be invited to keep the device in their home for 3 months in total, which will therefore cover periods during which they do not receive IV diuretics, but are still at relatively high risk of decompensation. That data will be analysed in the same fashion as the data collected in WS2.
干预措施: Connected weighing scales (Device)
Work Stream 2 (WS2)
The general aim of WS2 is to assess the hypothesis "can the Heartfelt device be used to monitor heart failure stability and detect fluid overload in patients recently discharged after an episode of decompensated heart failure?".
This work stream will also aim to examine whether the Heartfelt device gives an indication of the number of days prior to hospital admissions that the Heartfelt device can detect changes in foot volume. This will be achieved by comparing the data collected by the Heartfelt device in the participants' home, and correlating it to weight readings and medical observations. Hospital admissions will be a particularly useful correlation point as it would provide information on the detection of the forming oedema leading up to this event. In future, the information collected during this study will be used to design and power an interventional study to demonstrate the effectiveness of such data in providing a leading indicator of hospitalisation.
干预措施: Heartfelt Device (Device)
Work Stream 2 (WS2)
The general aim of WS2 is to assess the hypothesis "can the Heartfelt device be used to monitor heart failure stability and detect fluid overload in patients recently discharged after an episode of decompensated heart failure?".
This work stream will also aim to examine whether the Heartfelt device gives an indication of the number of days prior to hospital admissions that the Heartfelt device can detect changes in foot volume. This will be achieved by comparing the data collected by the Heartfelt device in the participants' home, and correlating it to weight readings and medical observations. Hospital admissions will be a particularly useful correlation point as it would provide information on the detection of the forming oedema leading up to this event. In future, the information collected during this study will be used to design and power an interventional study to demonstrate the effectiveness of such data in providing a leading indicator of hospitalisation.
干预措施: Connected weighing scales (Device)
结局指标
主要结局
Response to device by carers
时间窗: 3 months
Is the device well received by carers?
Use of the device to optimise drug management
时间窗: 3 months
Can the volumes measured by the Heartfelt device be useful in titrating and optimising drug management for patients undergoing home-IV diuretics? (WS1)
Use of the device to monitor heart failure stability and detect fluid overload
时间窗: 3 months
Can the Heartfelt device can be used to monitor heart failure stability and detect fluid overload in patients recently discharged after an episode of decompensated heart failure? (WS2)
Response to device by patients
时间窗: 3 months
Is the device well received by patients?
次要结局
- Number of days prior to hospital admission the device can detect changes in foot volume(3 months)