Feasibility, Heart Failure, Hospitalizations, Mentoring, Telemonitoring
Conditions
Brief summary
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: * Are implementation strategies effective in facilitating participant fidelity? * What factors contribute to patients' satisfaction with the designed intervention, and how can these be optimized for improved patient experience and adherence? * Are the methods and tools established the most appropriate to ensure the completeness of the data collection? Participants will follow a combined intervention consisting of: 1. pre-discharge educational meeting; 2. telephone nurse-led coaching sessions; 3. home telemonitoring of vital signs. 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
Interventions
COMBINATION_PRODUCTNurse-led telephone coaching intervention with home telemonitoring of vital signs
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
Sponsors
Alberto Dal Molin
Azienda Ospedaliero Universitaria Maggiore della Carita
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The assessors will collect clinical outcomes by telephone and will be blinded to the group assignment
Intervention model description
A parallel, open-label randomized controlled feasibility study
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* aged 65 and over * hospitalized for cardiac decompensation, regardless of ejection fraction (FE) value (preserved or decreased) * expected to be discharged home will be considered eligible.
Exclusion criteria
* Individuals who lack the cognitive and/or physical capabilities (Mini-COG +) for self-monitoring of vital signs, and without a caregiver available to assist them * people who receive other medical services
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 6 months | the proportion of patients who agreed to participate relative to those who fulfilled the inclusion criteria. |
| Retention rate | 6 months | the proportion of patients who complete the study and those who consent to participate |
| Adherence to the coaching intervention | 4 months. | the number of coaching phone calls scheduled and actualized |
| Adherence to telemonitoring program | 4 months. | the proportion of days during which vital signs were measured and sent by the system relative to the total duration of the intervention |
| Completeness of data collection | baseline, after 3 and 6 months | number of returned questionnaires. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 ) | Data collection is planned at baseline, 3 and 6 months. | The self-care capacity of the patient encompasses three dimensions: self-care maintenance, self-care monitoring and symptom perception, and self-care management |
| Self Care - Self-Efficacy Scale | Data collection is planned at baseline, 3 and 6 months. | 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 |
| Quality of life (SF-12 scale) | Data collection is planned at baseline, 3 and 6 months. | 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 |
| Anxiety (Hamilton Anxiety Scale ) | Data collection is planned at baseline, 3 and 6 months. | The detection of anxiety symptoms (psychological and somatic). |
| Heart Failure Somatic Perception Scale v.3 (HFSPS) | Data collection is planned at baseline, 3 and 6 months. | The detecion of somatic symptoms of the disease |
| Depression (Geriatric Depression Scale) | Data collection is planned at baseline, 3 and 6 months. | The detection of depressive symptoms of the elderly |
| Mortality | Data collection is planned at 3 and 6 months. | — |
| 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. | — |
| 90- and 180-day Emergency Departments visits | Data collection is planned at 3 and 6 months. | — |
Countries
Italy
Contacts
STUDY_CHAIRINES BASSO, Dr
Università degli Studi del Piemonte Orientale Amedeo Avogadro
Outcome results
None listed