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

Alberto Dal Molin

Status: Enrolling

Conditions: Mentoring; Feasibility; Telemonitoring; Heart Failure; Hospitalizations

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06285565

CE390/2023

Details and patient eligibility

About

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

Enrollment: 45 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups

Nurse-led supported group

Experimental group

Description:

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.

Treatment:

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

Controlled group

No Intervention group

Description:

The controlled group will receive usual care