EVOLVING AZIMUTH IN MUSA CONTEXT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-02

Study Completion Date

2025-08-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Heart Failure Blood Pressure Weight Change Telemonitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Telemonitoring

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.

Group Type EXPERIMENTAL

Telemonitoring app

Intervention Type DEVICE

periodic measurement of blood pressure and body weight

Standard care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telemonitoring app

periodic measurement of blood pressure and body weight

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No