Implementation and Cost-evaluation of a Smartphone-based Telemonitoring and Digital Support in Patients With HF

Summary

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.

Conditions

• Heart Failure
• Heart Failure NYHA Class II
• Heart Failure NYHA Class III
• Heart Failure NYHA Class IV

Interventions

DEVICE

Comunicare Solutions Smartphone Application

The Comunicare patient support solution is specifically designed for digital support of HF. It consists of an application for patients and a dashboard for the caregivers. The application is a class 1 certified medical device. It includes different modules for patient education, medication adherence, symptoms tracking, electronic patient-reported outcome (ePRO), appointments, and video consultation. Caregiver dashboard application: this web-based application enables caregivers to administrate the care flow and review all patient-reported data and the alarm generated by the system. Security and Privacy: the application complies with strict security and privacy-related regulations. All data storages are encrypted on the patients' smartphone and a server located in an ISO-certified data center located in Belgium, and all information exchanges are highly secured. A GDPR-compliant privacy notice defines how patient personal data is processed and how data protection principles are applied.

OTHER

Completing a quality of life (QOL)-questionnaire

Patients refusing to use Comunicare app will also be asked to complete a quality of life (QOL)-questionnaire at 0, 6 and 12 months which will be answered online.

Sponsors & Collaborators

• Jessa Hospital

  collaborator OTHER

• Hasselt University, Faculty of Medicine and Life Sciences, Hasselt, Belgium

  collaborator UNKNOWN

• KU Leuven

  collaborator OTHER

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  collaborator OTHER

• Centre Hospitalier Régional de la Citadelle

  collaborator OTHER

• Comunicare Solutions SA

  lead INDUSTRY

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-21

Primary Completion

2022-11-21

Completion

2022-11-21

Countries

• Belgium

Study Locations