EVOLVING AZIMUTH IN MUSA CONTEXT

NCT07022067 | Recruiting

• 1 other identifier: 4372
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Heart Failure; Blood Pressure; Weight Change; Telemonitoring

Outcome Measures

Primary Outcomes (1)

• PAM13-I

  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).

  6 months

Study Arms (2)

Telemonitoring

EXPERIMENTAL

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.

Device: Telemonitoring app

Standard care

NO INTERVENTION

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.

Interventions

Telemonitoring app DEVICE

periodic measurement of blood pressure and body weight

Telemonitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead
• ASST Grande Ospedale Metropolitano Niguarda: collaborator
• University of Milan: collaborator

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure; Body Weight Changes

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefano Prof. Carugo

  IRCCS Fondazione Caì Granda Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Prof. Carugo

CONTACT

+390255033532; stefano.carugo@policlinico.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Cardio-Thoracic-Vascular Diseases

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 15, 2025
• Study Start: October 2, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 31, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

IT (1)