A Nurse-led Coaching Programme With Telemonitoring in Heart Failure

Heart Failure Clinical Trial

— INTERCOACH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06285565
• Other study ID #: CE390/2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: June 2024
• Source: Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
• Contact: Mattia Bellan, Prof
• Phone: 00393470124661
• Email: mattia.bellan[@]med.uniupo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Feasibility
• Heart Failure
• Hospitalizations
• Mentoring

Intervention

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

Locations

Country	Name	City	State
Italy	Università del Piemonte Orientale Amedeo Avogadro	Novara

Sponsors (2)

Lead Sponsor	Collaborator
Alberto Dal Molin	Azienda Ospedaliero Universitaria Maggiore della Carita

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	the proportion of patients who agreed to participate relative to those who fulfilled the inclusion criteria.	6 months
Primary	Retention rate	the proportion of patients who complete the study and those who consent to participate	6 months
Primary	Adherence to the coaching intervention	the number of coaching phone calls scheduled and actualized	4 months.
Primary	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.
Primary	Completeness of data collection	number of returned questionnaires.	baseline, after 3 and 6 months
Secondary	90- and 180-day all-cause hospital readmissions		Data collection is planned at 3 and 6 months.
Secondary	90- and 180-day heart failure-related hospital readmissions		Data collection is planned at 3 and 6 months.
Secondary	90- and 180-day Emergency Departments visits		Data collection is planned at 3 and 6 months.
Secondary	90- and 180-day General Practioner visits		Data collection is planned at 3 and 6 months.
Secondary	90- and 180-day oupatient visits		Data collection is planned at 3 and 6 months.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Anxiety (Hamilton Anxiety Scale )	The detection of anxiety symptoms (psychological and somatic).	Data collection is planned at baseline, 3 and 6 months.
Secondary	Depression (Geriatric Depression Scale)	The detection of depressive symptoms of the elderly	Data collection is planned at baseline, 3 and 6 months.
Secondary	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.
Secondary	Mortality		Data collection is planned at 3 and 6 months.