Implementation and Cost-evaluation of a Smartphone-based Telemonitoring and Digital Support Platform in Patients With Heart Failure: the Bedicare-HF Multicentre Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Efficiency measures
研究概览
简要总结
The BEDICARE-HF study aims to go further in the research on digital support. The objectives of this study are to demonstrate the feasibility, acceptability, adoption, sustainability and safety of a of a smartphone-based digital support system in the Belgian healthcare system. It also aims to effectiveness, evaluate the cost of implementation of the system and demonstrate the cost-effectiveness.
The study is multi-center, involving the principal investigator, Dr. Pouleur at Cliniques University Clinics Brussels, and co-investigators from 10 hospitals across Belgium. These physicians will enroll 15 patients on Comunicare's online platform. The patients will then have access to the Comunicare application for 6 months, where they will be asked to answer questionnaires and take their vital parameters. They will also have access to documentation on their pathology and will be able to perform videoconferences with their doctor/nurse via the platform.
Eligible patients are patients discharged from hospital for cardiac decompensation. At the time of inclusion, patients must be in NYHA (New-York Heart association) class II, III, or IV, with an LVEF (ejection fraction ejection fraction) of ≤50%.
The BEDICARE-HF project is based on the standard of care that an HF (heart fealure) patient would receive without being part of any study. No other invasive interventions are additionally planned by the project. The patient data collected by the recruiting physician is secured by Comunicare. These fully anonymized data will be sent to Jessa at the end of the study for statistical and economic economic analysis of the results.
The BEDICARE-HF study will therefore investigate the implementation of a digital support intervention for HF supported by smartphone in a European legislative framework. This study will allow further in the evaluation of digital support for HF and to evaluate a low-cost smartphone solution. The results of this study will demonstrate whether and how a smartphone-based digital support system improves self-care capabilities, clinical management, and health outcomes of patients with HF. They will provide important information on the implementation of a implementation of a digital support system in a specific healthcare setting.
详细描述
Heart failure (HF) is a chronic condition and one of the most challenging issues is to reduce hospital admission and readmission rates for worsening HF. The prevalence of HF is estimated at 1-2% of the total population and ≥10% among people >70 years of age. Increasingly, telemonitoring is used as a solution to intervene at the start of an HF decompensation before the patient starts to be symptomatic and to avoid hospitalization. In recent years, many trials have been published that investigate the utility of telemonitoring in HF in different modalities including invasive monitoring and non-invasive monitoring.
The most recent large randomized controlled trial (RCT) that demonstrated the efficacy of telemonitoring in HF is the TIM-HF2 trial in which a structured remote patient management intervention reduced the percentage of days lost to unplanned cardiovascular hospital admission and all-cause mortality in patients with New York Heart Association (NYHA) class II-III HF with a hospitalization within the last 12 months.
The utility of smartphone applications for patient care is increasingly being appreciated and in Europe, clear guidelines exist for developers who aim to develop software as a medical device. The advantage of using smartphone applications is that little specialized equipment is needed and, if a digital support program is proven successful, implementation can be widely performed at low cost.
In the context of the Covid-19 pandemic, HF patients are particularly suffering from the difficulty to meet their cardiologist and HF nurse on a regular basis. Developing the possibility for remote monitoring is a key alternative to avoid re-hospitalization or severe clinical cardiovascular outcome.
The sponsor present the design of the Bedicare-HF trial, which aims to take digital support research a step further. It uses an implementation design approach in which a real-life setting will be approximated. The trial aims thus to not only demonstrate the effectiveness of a smartphone-based HF digital support approach but also the feasibility of implementation in a European healthcare context. Also, it aims to evaluate the cost-effectiveness of a smartphone-based digital support approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Diagnosed with HF - NYHA class II-IV
- •LVEF ≤50%.
- •Hospitalisation due to decompensated HF at the moment of inclusion or up to 1 month prior to inclusion (i.e. discharged ≤1 month prior to inclusion).
- •Owning a smartphone and able to use an application
- •Written informed consent obtained
排除标准
- •Acute coronary syndrome
- •High urgent listed for heart transplantation
- •Planned revascularisation, TAVI, MitraClip and/or CRT implantation within 3 months after inclusion
- •Known alcohol or drug abuse
- •Terminal renal insufficiency with haemodialysis or peritoneal dialysis
- •Impairment or unwillingness to use the digital support equipment (e.g. dementia, impaired self-determination, lacking ability to communicate)
- •Existence of any non-cardiac disease reducing life expectancy to less than 1 year
- •Age <18 years
- •Participation in other treatment studies or remote patient management programmes
结局指标
主要结局
Efficiency measures
时间窗: Through study completion, an average of 6 months
Demonstrate that this solution makes good use of time and energy in a way that does not waste it. This will be measured via daily time spent by case nurses using the platform, compared to time spent without the solution.
Cost-effectiveness
时间窗: Through study completion, an average of 6 months
To evaluate the implementation cost of the system, and to demonstrate cost-effectiveness. It will be calculated using healthcare cost data and work productivity and impairment (WPAI) questionnaire to calculate incremental cost-effectiveness ratio (ICER).
次要结局
- Adoption and sustainability(Through study completion, an average of 6 months)
- Quality of patient life(At the recruitment, after 3 ans 6 months)
- Patient literacy(At the recruitment, after 3 ans 6 months)
- Patient acceptability(at 3 and 6 months)
- Patient self-care(At the recruitment, after 3 ans 6 months)
- The rate of unplanned cardiovascular readmission/mortality(Through study completion, an average of 6 months)