Heart Failure Clinical Trial
— BEDICARE-HFOfficial title:
Implementation and Cost-evaluation of a Smartphone-based Telemonitoring and Digital Support Platform in Patients With Heart Failure: the Bedicare-HF Multicentre Trial
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.
Status | Recruiting |
Enrollment | 330 |
Est. completion date | November 21, 2022 |
Est. primary completion date | November 21, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Attipoe | Liège |
Lead Sponsor | Collaborator |
---|---|
Comunicare Solutions SA | Centre Hospitalier Régional de la Citadelle, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Hasselt University, Faculty of Medicine and Life Sciences, Hasselt, Belgium, Jessa Hospital, KU Leuven |
Belgium,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficiency measures | 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. |
Through study completion, an average of 6 months | |
Primary | Cost-effectiveness | 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). | Through study completion, an average of 6 months | |
Secondary | Patient acceptability | SUTAQ (Service User Technology Acceptability Questionnaire) | at 3 and 6 months | |
Secondary | Adoption and sustainability | Average created between the number of patients refusing inclusion, patients who dropped out before the end of the study, and patients continuing to use the application during the 6 months. | Through study completion, an average of 6 months | |
Secondary | Quality of patient life | MLHFQ (Minnesota living with heart failure questionnaire): comparison between the patient's quality of life with and without the tool | At the recruitment, after 3 ans 6 months | |
Secondary | Patient literacy | HLS-EU-Q16 (European Health literacy Questionnaire): comparison between patient literacy at recruitment and at the end of the study | At the recruitment, after 3 ans 6 months | |
Secondary | Patient self-care | EHFScB-9 (The European Heart Failure Self-care Behaviour scale): comparison between the self-care patient at recruitment and at the end of the study | At the recruitment, after 3 ans 6 months | |
Secondary | The rate of unplanned cardiovascular readmission/mortality | The difference between the rate of unplanned cardiovascular readmission/mortality in patients with and without the app. | Through study completion, an average of 6 months |
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