A Nurse-led Coaching Programme With Telemonitoring in Heart Failure

NCT06285565 | Completed

• 1 other identifier: CE390/2023
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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:
• pre-discharge educational meeting;
• telephone nurse-led coaching sessions;
• home telemonitoring of vital signs.

Conditions

Heart Failure; Telemonitoring; Hospitalizations; Feasibility; Mentoring

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (12)

• 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.

• 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.

Study Arms (2)

Nurse-led supported group

EXPERIMENTAL

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.

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

Controlled group

NO INTERVENTION

The controlled group will receive usual care

Interventions

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

Nurse-led supported group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alberto Dal Molin: lead
• Azienda Ospedaliero Universitaria Maggiore della Carita: collaborator

Study Sites (2)

Azienda Ospedaliero-Universitaria maggiore della Carità di Novara

Novara, Novara, 28100, Italy

Location

Università del Piemonte Orientale Amedeo Avogadro

Novara, Novara, 28100, Italy

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• INES BASSO, Dr

  Università degli Studi del Piemonte Orientale Amedeo Avogadro

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessors will collect clinical outcomes by telephone and will be blinded to the group assignment
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: A parallel, open-label randomized controlled feasibility study

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 29, 2024
• Study Start: September 17, 2024
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)