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

NAUnknownINTERVENTIONAL
Enrollment

330

Participants

Timeline

Start Date

May 21, 2022

Primary Completion Date

November 21, 2022

Study Completion Date

November 21, 2022

Conditions
Heart FailureHeart Failure NYHA Class IIHeart Failure NYHA Class IIIHeart 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.

Trial Locations (1)

4000

RECRUITING

Attipoe, Liège

Sponsors
All Listed Sponsors
collaborator

Jessa Hospital

OTHER

collaborator

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

UNKNOWN

collaborator

KU Leuven

OTHER

collaborator

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

collaborator

Centre Hospitalier Régional de la Citadelle

OTHER

lead

Comunicare Solutions SA

INDUSTRY