A Nurse-led Coaching Programme With Telemonitoring in Heart Failure

NCT ID: NCT06285565

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-17
• Study Completion Date: 2025-07-01

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

Conditions

Heart Failure; Telemonitoring; Hospitalizations; Feasibility; Mentoring

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Nurse-led supported group

A supportive program consisting of the following elements will be provided:

1. Pre-discharge educational meeting. After the patient is deemed stable, an in-hospital educational intervention will be provided by a trained nurse not involved in the clinical pathway. Key topics of self-care management recognized by the European Society of Cardiology will be discussed.

2. Telephone nurse-led coaching sessions. In this phase, patients will be encouraged to focus on their values and progress towards their goals. The intervention will be customized based on the objectives identified during the initial meeting. The scheduled sessions will occur weekly during the first months and then transition to twice a month thereafter.

3. Patients will receive education on measuring weight, blood pressure, heart rate, and oxygen saturation at rest, every morning before breakfast. All participants will be provided with a telemonitoring system that transmits data to a web platform via Bluetooth.

Group Type: EXPERIMENTAL

Nurse-led telephone coaching intervention with home telemonitoring of vital signs

Intervention Type: 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

Controlled group

The controlled group will receive usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nurse-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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero Universitaria Maggiore della Carita

OTHER

Sponsor Role: collaborator

Alberto Dal Molin

OTHER

Sponsor Role: lead

Responsible Party

Alberto Dal Molin

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

INES BASSO, Dr

Role: STUDY_CHAIR

Università degli Studi del Piemonte Orientale Amedeo Avogadro

Locations

Azienda Ospedaliero-Universitaria maggiore della Carità di Novara

Novara, , Italy

Site Status: RECRUITING

Università del Piemonte Orientale Amedeo Avogadro

Novara, , Italy

Site Status: NOT_YET_RECRUITING

Countries

Italy

Central Contacts

Mattia Bellan, Prof

Role: CONTACT

mattia.bellan@med.uniupo.it

00393470124661

Alberto Dal Molin, Prof

Role: CONTACT

alberto.dalmolin@med.uniupo.it

Facility Contacts

Role: primary

3927599727

Alberto Dal Molin, Prof

Role: primary

alberto.dalmolin@med.uniupo.it

+390321660607

INES BASSO

Role: backup

ines.basso@uniupo.it

+393927599727

Other Identifiers

CE390/2023

Identifier Type: -

Identifier Source: org_study_id