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| Name | Class |
|---|---|
| ASST Grande Ospedale Metropolitano Niguarda | OTHER |
| University of Milan | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemonitoring app | Device | periodic measurement of blood pressure and body weight |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefano Prof. Carugo | Contact | +390255033532 | stefano.carugo@policlinico.mi.it |
| Name | Affiliation | Role |
|---|---|---|
| Stefano Prof. Carugo | IRCCS Fondazione CaƬ Granda Ospedale Maggiore Policlinico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Recruiting | Milan | Italy | 20122 | Italy |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |