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NCT Number: NCT07022067

EVOLVING AZIMUTH IN MUSA CONTEXT

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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Key information

Conditions

Heart Failure Blood Pressure Body Weight Body Weight Changes Cardiovascular Diseases Heart Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Telemonitoring Weight Change

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy, 20122

Location status: Recruiting

Location contact

Prof. Carugo

CONTACT

[email protected]

+390255033532

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemonitoring app

Device

periodic measurement of blood pressure and body weight

Primary outcomes

  1. PAM13-I

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Stefano Prof. Carugo

CONTACT

[email protected]

+390255033532

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Collaborators

  • ASST Grande Ospedale Metropolitano Niguarda
  • University of Milan

Registry information

Acronym: AZIMUSA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2025
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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