Randomised Controlled Trial For Assessing The Effectiveness Of An Inclusive Heart Failure Monitoring And Tracking Solution In The UK.(HF-TRACK)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 186
- 试验地点
- 20
- 主要终点
- All-Cause Mortality Rate.
研究概览
简要总结
The objective of our research is to evaluate the effectiveness of an innovative medical device designed to measure foot and lower leg sizes in detecting early indications of deteriorating heart failure. This health condition frequently causes leg swelling and breathing difficulties due to fluid accumulation. Early detection of these symptoms is vital for effective management, potentially preventing the need for hospitalization.
Fluid retention in the lower legs and lungs, manifesting as swollen ankles and shortness of breath, is a common sign of progressing heart failure. Often, a slight increase in body weight is the first warning of fluid accumulation, occurring before noticeable swelling or breathing issues arise. Early identification of these fluid accumulation signs is critical for timely intervention, which can avert the necessity for hospital admittance. Patients are usually encouraged to monitor their weight, check for swelling in the ankles, observe their breathing, and consult with their healthcare provider or heart failure specialist at the first sign of these symptoms. In many cases, patients can report these symptoms in time for their healthcare team to adjust their treatment accordingly. Diuretics, or water pills, are often prescribed to help eliminate excess fluid, effectively preventing hospital admissions when used promptly.
The Heartfelt device may provide a useful solution for individuals who find it challenging to consistently monitor these indicators and their weight. It is designed to detect early warning signs seamlessly without imposing additional tasks on the patient's daily routine. The device, intended to complement rather than replace self-monitoring practices, is user-friendly and operates by scanning the feet for any size changes, positioned conveniently by the bedroom floor. This capability allows healthcare professionals to make informed decisions swiftly about patient care, potentially adjusting treatments to avoid further health complications. The device captures images of the feet only, ensuring privacy.
This study aims to ascertain the device's practical effectiveness in real-world scenarios, aiming to collect precise data to confirm its potential benefits for patients facing heart failure challenges.
详细描述
This study has been co-designed with existing and past users (patients and their carers) of the Heartfelt device who have in the past expressed an interest in sharing their opinion for future research.
It is a 6 months crossover randomised controlled trial designed to evaluate the effectiveness of the Heartfelt device, a remote patient monitoring system, in reducing the risk of hospitalisation for heart failure (HF) by monitoring peripheral oedema.
We will focus on patients with heart failure who have had at least one hospitalisation for heart failure associated with peripheral oedema in the last year, with stratified randomisation (for the RCT part) to avoid recent discharge effects in the early phases of data collection and focussing on patients considered at high-risk of poor long-term adherence to daily weights (the majority of patients with heart failure). [8-Fitzgerald].
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
Only outcomes assessors will be blinded.
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
- •In order to be eligible to participate in this trial, an individual must meet all of the following criteria:
- •Provision of signed and dated informed consent form (e-consent via website or app is acceptable).
- •Women or men, aged 18 years or older [No maximum age].
- •Diagnosis of heart failure at least 3 months previously
- •Receiving diuretics on a daily basis
- •Peripheral oedema reported on at least one HF-related hospitalisation in the last 4 years (as documented in EPR).
- •Hospitalised for HF OR on a Virtual Ward for HF OR has received IV diuretic treatment in the last 12 months, or treated with at least 80 mg furosemide (or equivalent) orally per day.
- •For women 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.
- •Is considered by the investigator to be non-adherent OR at high risk of HF hospital readmissions.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •bandages to lower limbs every day
- •amputation of both feet
- •regular wheelchair user inside their home
- •bed-bound
- •no fixed abode
- •taking part in a conflicting evaluation/study that could confound the results of this evaluation and/or impact clinical interventions and participant outcomes
- •Pregnancy or lack of contraceptive measures if of child-bearing potential†
- •Inability to install the device (even with assistance) allowing at least 6 months of data capture by the end of the study.
- •Patients with severe aortic stenosis or awaiting a heart procedure or surgery
- •† This exclusion criterion has been requested by the insurance provider for clinical trial cover.
研究组 & 干预措施
Standard Care + Heartfelt device
In addition to standard care activities, participants have the Heartfelt device at home. During this arm, the device sends alerts and measurement data to the patient, carers and clinicians.
干预措施: Heartfelt Device installed (Device)
Standard Care + Heartfelt device
In addition to standard care activities, participants have the Heartfelt device at home. During this arm, the device sends alerts and measurement data to the patient, carers and clinicians.
干预措施: Standard care (Other)
Standard Care + Heartfelt device
In addition to standard care activities, participants have the Heartfelt device at home. During this arm, the device sends alerts and measurement data to the patient, carers and clinicians.
干预措施: Questionnaires (Other)
Standard Care + Heartfelt device
In addition to standard care activities, participants have the Heartfelt device at home. During this arm, the device sends alerts and measurement data to the patient, carers and clinicians.
干预措施: Heartfelt device alerting system (Device)
Standard care (control)
In addition to standard care activities, participants have the Heartfelt device at home. During this arm, data is captured without sending health alerts or measurement data to the patient, carers and clinicians.
干预措施: Heartfelt Device installed (Device)
Standard care (control)
In addition to standard care activities, participants have the Heartfelt device at home. During this arm, data is captured without sending health alerts or measurement data to the patient, carers and clinicians.
干预措施: Standard care (Other)
Standard care (control)
In addition to standard care activities, participants have the Heartfelt device at home. During this arm, data is captured without sending health alerts or measurement data to the patient, carers and clinicians.
干预措施: Questionnaires (Other)
Standard Care + Heartfelt device in pharmacy
Participants will follow standard care advice, and have monthly measurements taken at the pharmacy using the Heartfelt device. The pharmacist will receive the measurements and alerts and be able to communicate this to the participant.
干预措施: Standard care (Other)
Standard Care + Heartfelt device in pharmacy
Participants will follow standard care advice, and have monthly measurements taken at the pharmacy using the Heartfelt device. The pharmacist will receive the measurements and alerts and be able to communicate this to the participant.
干预措施: Questionnaires (Other)
Standard Care + Heartfelt device in pharmacy
Participants will follow standard care advice, and have monthly measurements taken at the pharmacy using the Heartfelt device. The pharmacist will receive the measurements and alerts and be able to communicate this to the participant.
干预措施: Heartfelt Device in pharmacy (Device)
Standard Care + Heartfelt device in pharmacy
Participants will follow standard care advice, and have monthly measurements taken at the pharmacy using the Heartfelt device. The pharmacist will receive the measurements and alerts and be able to communicate this to the participant.
干预措施: Heartfelt device alerting system (Device)
结局指标
主要结局
All-Cause Mortality Rate.
时间窗: Through study completion, an average of 6 months
This measure tracks the total number of participant deaths due to any cause during the study period. It is an essential indicator of overall participant survival and general safety of the treatment under investigation. This data is collected and verified through clinical records. Measure: The number of all-cause deaths documented in clinical records. Unit of Measure: Count of deaths.
Device-Related Complication Rate.
时间窗: Through study completion, an average of 6 months
This measure captures the frequency of complications associated with the medical device used in the study. It includes any adverse events or malfunctions linked to the device, providing insight into its safety and performance. Measure: The incidence of complications related to the medical device in use, as specified in Sections 8.1.4 and 8.1.5 of the study protocol. Unit of Measure: Count of complication events.
Heart Failure Events Incidence.
时间窗: Through study completion, an average of 6 months
This metric quantifies the number of times participants have heart failure events. The criteria for what constitutes a heart failure event are based on the definition provided by Abraham WT in 2020, ensuring standardised and specific event classification. Measure: The frequency of hospital events specifically for heart failure, as defined by Abraham WT, 2020. Unit of Measure: Count of heart failure events.
次要结局
- Hospital Admission Duration(Through study completion, an average of 6 months)
- Cause of Hospitalization(Through study completion, an average of 6 months)
- Hospitalisation Admission Route(Through study completion, an average of 6 months)
- Loss of Independence(Through study completion, an average of 6 months)
- Scheduling of Care Events(Through study completion, an average of 6 months)
- Setting of Care Events(Through study completion, an average of 6 months)
- Date of Changes in HF Medication Post-Discharge(Through study completion, an average of 6 months)
- Changes in dosage of HF Medication Post-Discharge(Through study completion, an average of 6 months)
- Comparison of Data Availability (number of days with data in a month): Heartfelt Device vs. Existing Remote Monitoring Devices(Through study completion, an average of 6 months)
- Timestamp of Health Alerts Generated by the Heartfelt Device(Through study completion, an average of 6 months)
- Frequency of Health Alerts Generated by the Heartfelt Device(Through study completion, an average of 6 months)
- Foot volume(Through study completion, an average of 6 months)
- Weight(Through study completion, an average of 6 months)
- Peripheral oedema grading(Through study completion, an average of 6 months)
- Cause of Death(Through study completion, an average of 6 months)
- Date of Death(Through study completion, an average of 6 months)