A Nurse-led Coaching Programme With Telemonitoring in Heart Failure (INTERCOACH)

A Nurse-led Coaching Programme With Telemonitoring in Heart Failure: Protocol for a Randomized Controlled Feasibility Study

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

Study Overview

• Status: Completed
• Conditions: Heart Failure; Feasibility; Mentoring; Hospitalizations; Telemonitoring
• Intervention / Treatment: Combination product: Nurse-led telephone coaching intervention with home telemonitoring of vital signs

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Novara
    • Novara, Novara, Italy, 28100
      • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
    • Novara, Novara, Italy, 28100
      • Università del Piemonte Orientale Amedeo Avogadro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nurse-led supported group; A supportive program consisting of the following elements will be provided: 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.; 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.; 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; 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
No Intervention: Controlled group; The controlled group will receive usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: Alberto Dal Molin
• Collaborators: Azienda Ospedaliero Universitaria Maggiore della Carita
• Investigators: Study Chair: INES BASSO, Dr, Università degli Studi del Piemonte Orientale Amedeo Avogadro

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2024
• Primary Completion (Actual): December 15, 2025
• Study Completion (Actual): December 15, 2025

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: CE390/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No