EVOLVING AZIMUTH IN MUSA CONTEXT (AZIMUSA)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Weight Change; Telemonitoring; Heart Failure; Blood Pressure

Treatments: Device: Telemonitoring app

Study type: Interventional

Funder types: Other

Identifiers

NCT07022067

4372

Details and patient eligibility

About

Non-pharmacological, randomized, nonprofit medical device intervention. The study aims to identify the positive impacts (co-creation), and negative impacts (co-destruction), resulting from the use of telemedicine, and, in particular, the telemonitoring service for patients with heart failure

Full description

The patient diagnosed with heart failure is randomized to either the experimental or control arm. The patient in the experimental arm downloads a telemonitoring application where they enter their pressure and body weight data, which is revised by the hospital team via a platform. Patients from both arms complete a questionnaire during enrollment and during two follow-ups (3 months and 6 months) to examine various dimensions.

Enrollment: 184 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have been diagnosed with chronic CS according to the ESC guidelines;
• Over 18 years of age;
• Patients admitted to hospital or with access to first aid within the last year;
• Smartphome that meets the digital requirements (ie Android or iOS able to download and use the application);
• Wi-Fi or 3G coverage at home;
• Ability to give written informed consent.

Exclusion criteria

• Severe psychiatric disorder
• Inability to use portable technologies
• Patients unable to use the equipment provided
• Patients who deny consent to study participation

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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184 participants in 2 patient groups

Telemonitoring

Experimental group

Description:

The patient in the experimental arm downloads a telemonitoring application where they enter their pressure and body weight data, which is revised by the hospital team via a platform. The patient complete a questionnaire during enrollment and during two follow-ups (3 months and 6 months) to examine various dimensions.

Treatment:

Device: Telemonitoring app

Standard care

No Intervention group

Description:

The patient in the standard care arm do not downloads a telemonitoring application, but they continue with normal medical indication. The patient complete a questionnaire during enrollment and during two follow-ups (3 months and 6 months) to examine various dimensions.