EVOLVING AZIMUTH IN MUSA CONTEXT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Telemonitoring app.
- Who it may be relevant to
- Registry conditions: Heart Failure, Blood Pressure, Weight Change, Telemonitoring. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Detailed 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.
Interventions
- Device Telemonitoring app
periodic measurement of blood pressure and body weight
Primary outcome measures
- PAM13-I [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Italy · 1 center
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan
Identifiers
NCT: NCT07022067 · 4372