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Clinical Trials in Italy / NCT07022067
Recruiting Not applicable

EVOLVING AZIMUTH IN MUSA CONTEXT

NCT07022067 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Phase
Not applicable
Started
2024-10-02
Last updated
2025-06-15

Condition(s) studied

Heart FailureBlood PressureWeight ChangeTelemonitoring

Investigational drug(s) / intervention(s)

Telemonitoring app

Telemonitoring app: periodic measurement of blood pressure and body weight

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • PAM13-I — 6 months
    The Patient Activation Measure (PAM13-I) is a brief, validated instrument that assesses patient knowledge, skills, and confidence for disease self-management. It consists of 13 items on a Likert scale. According to the American version of PAM 13, each item has five response categories with scores from 1 to 5: (1) "Strongly Disagree", (2) "Disagree", (3) "Agree", (4) "Strongly Agree" and (5) "Not Applicable". The instrument design reflects the four stages of activation in a progressing difficulty of the items: level 1 (patients believe that their role is important: items 1 and 2), level 2 (patients have confidence and knowledge to take action: items 3-8) level 3 (taking action: items 9-11) and level 4 (staying on course under stress: items 12 and 13).

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07022067 on ClinicalTrials.gov ↗ ← All trials in Italy