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| Name | Class |
|---|---|
| Azienda Ospedaliero Universitaria Maggiore della Carita | OTHER |
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The goal of this pilot interventional study is to assess the feasibility and acceptability of a supportive intervention for patients affected by heart failure. The main questions it aims to answer are:
Participants will follow a combined intervention consisting of:
In the main trial, researchers will compare data from the intervention group with a control group to assess whether it reduces hospitalization rates and improves self-care capabilities
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nurse-led supported group | Experimental | A supportive program consisting of the following elements will be provided:
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| Controlled group | No Intervention | The controlled group will receive usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse-led telephone coaching intervention with home telemonitoring of vital signs | Combination Product | In addition to standard care, the intervention group will receive a nurse-led supportive programme that involves a pre-discharge educational meeting and 6-month telephone coaching sessions. Patient's caregivers will also be invited to participate. After discharge, patients will be asked to measure their vital signs, daily. In case of alteration, the nurse will ascertain the presence of congestion symptoms and decide to reinforce the recommendations for self-management, request a specialist medical consultant, or refer to the emergency services |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | the proportion of patients who agreed to participate relative to those who fulfilled the inclusion criteria. | 6 months |
| Retention rate | the proportion of patients who complete the study and those who consent to participate | 6 months |
| Adherence to the coaching intervention | the number of coaching phone calls scheduled and actualized | 4 months. |
| Adherence to telemonitoring program | the proportion of days during which vital signs were measured and sent by the system relative to the total duration of the intervention | 4 months. |
| Completeness of data collection | number of returned questionnaires. | baseline, after 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 90- and 180-day all-cause hospital readmissions | Data collection is planned at 3 and 6 months. | |
| 90- and 180-day heart failure-related hospital readmissions | Data collection is planned at 3 and 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| INES BASSO, Dr | Università degli Studi del Piemonte Orientale Amedeo Avogadro | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria maggiore della Carità di Novara | Novara | Novara | 28100 | Italy | ||
| Università del Piemonte Orientale Amedeo Avogadro |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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A parallel, open-label randomized controlled feasibility study
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The assessors will collect clinical outcomes by telephone and will be blinded to the group assignment
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| 90- and 180-day Emergency Departments visits | Data collection is planned at 3 and 6 months. |
| 90- and 180-day General Practioner visits | Data collection is planned at 3 and 6 months. |
| 90- and 180-day oupatient visits | Data collection is planned at 3 and 6 months. |
| Self-care capacity (Self-Care of Heart Failure Index ) | The self-care capacity of the patient encompasses three dimensions: self-care maintenance, self-care monitoring and symptom perception, and self-care management | Data collection is planned at baseline, 3 and 6 months. |
| Self Care - Self-Efficacy Scale | Self-care capacity is mediated by self-efficacy perception, which is the individual's belief in their ability to achieve certain goals as a result of their actions, regardless of the challenges and difficulties they may face. A scale consisting of 10 items using a 5-response Likert scale will be utilized | Data collection is planned at baseline, 3 and 6 months. |
| Quality of life (SF-12 scale) | The quality of life is a value that integrates objective indicators (physical health, personal circumstances, social relationships, social and economic influences) and subjective ones (such as how the individual responds to objective conditions) related to various dimensions of life and personal values | Data collection is planned at baseline, 3 and 6 months. |
| Anxiety (Hamilton Anxiety Scale ) | The detection of anxiety symptoms (psychological and somatic). | Data collection is planned at baseline, 3 and 6 months. |
| Depression (Geriatric Depression Scale) | The detection of depressive symptoms of the elderly | Data collection is planned at baseline, 3 and 6 months. |
| Heart Failure Somatic Perception Scale v.3 (HFSPS) | The detecion of somatic symptoms of the disease | Data collection is planned at baseline, 3 and 6 months. |
| Mortality | Data collection is planned at 3 and 6 months. |
| Novara |
| Novara |
| 28100 |
| Italy |