EVOLVING AZIMUTH IN MUSA CONTEXT

ConditionsHeart Failure Blood Pressure Weight Change Telemonitoring

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

Severe psychiatric disorder

Inability to use portable technologies

Patients unable to use the equipment provided

Patients who deny consent to study participation

Trial design

Design model

Parallel

Treatments tested in this trial

Telemonitoring app
Device
periodic measurement of blood pressure and body weight

Treatment groups

184 Participants

are divided into 2 treatment groups

Group A: TelemonitoringExperimental treatment 1 intervention

Group B: Standard careNo intervention 0 interventions

Trial outcomes

Primary outcomes

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).

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Lead sponsor

ASST Grande Ospedale Metropolitano Niguarda

Collaborator

University of Milan

Collaborator

Source ClinicalTrials.gov

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