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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Azienda Ospedaliero-Universitaria maggiore della Carità di Novara
RECRUITING
Novara
Università del Piemonte Orientale Amedeo Avogadro
NOT_YET_RECRUITING
Novara
Contact Information
Primary
Mattia Bellan, Prof
mattia.bellan@med.uniupo.it
00393470124661
Backup
Alberto Dal Molin, Prof
alberto.dalmolin@med.uniupo.it
Time Frame
Start Date: 2024-09-17
Estimated Completion Date: 2025-07-01
Participants
Target number of participants: 45
Treatments
Experimental: 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.
No_intervention: Controlled group
The controlled group will receive usual care
Related Therapeutic Areas
Sponsors
Leads: Alberto Dal Molin
Collaborators: Azienda Ospedaliero Universitaria Maggiore della Carita

This content was sourced from clinicaltrials.gov