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Completed

NCT Number: NCT06285565

A Nurse-led Coaching Programme With Telemonitoring in Heart Failure

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Feasibility Heart Diseases Hospitalizations Mentoring Telemonitoring

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero-Universitaria maggiore della Carità di Novara, Novara, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Recruitment rate

    Time frame: 6 months

    the proportion of patients who agreed to participate relative to those who fulfilled the inclusion criteria.

  2. Retention rate

    Time frame: 6 months

    the proportion of patients who complete the study and those who consent to participate

  3. Adherence to the coaching intervention

    Time frame: 4 months.

    the number of coaching phone calls scheduled and actualized

  4. Adherence to telemonitoring program

    Time frame: 4 months.

    the proportion of days during which vital signs were measured and sent by the system relative to the total duration of the intervention

  5. Completeness of data collection

    Time frame: baseline, after 3 and 6 months

    number of returned questionnaires.

Secondary outcomes

  1. 90- and 180-day all-cause hospital readmissions

    Time frame: Data collection is planned at 3 and 6 months.

  2. 90- and 180-day heart failure-related hospital readmissions

    Time frame: Data collection is planned at 3 and 6 months.

  3. 90- and 180-day Emergency Departments visits

    Time frame: Data collection is planned at 3 and 6 months.

  4. 90- and 180-day General Practioner visits

    Time frame: Data collection is planned at 3 and 6 months.

  5. 90- and 180-day oupatient visits

    Time frame: Data collection is planned at 3 and 6 months.

  6. Self-care capacity (Self-Care of Heart Failure Index )

    Time frame: Data collection is planned at baseline, 3 and 6 months.

    The self-care capacity of the patient encompasses three dimensions: self-care maintenance, self-care monitoring and symptom perception, and self-care management

  7. Self Care - Self-Efficacy Scale

    Time frame: Data collection is planned at baseline, 3 and 6 months.

    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

  8. Quality of life (SF-12 scale)

    Time frame: Data collection is planned at baseline, 3 and 6 months.

    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

  9. Anxiety (Hamilton Anxiety Scale )

    Time frame: Data collection is planned at baseline, 3 and 6 months.

    The detection of anxiety symptoms (psychological and somatic).

  10. Depression (Geriatric Depression Scale)

    Time frame: Data collection is planned at baseline, 3 and 6 months.

    The detection of depressive symptoms of the elderly

  11. Heart Failure Somatic Perception Scale v.3 (HFSPS)

    Time frame: Data collection is planned at baseline, 3 and 6 months.

    The detecion of somatic symptoms of the disease

  12. Mortality

    Time frame: Data collection is planned at 3 and 6 months.

Sponsors and collaborators

Lead sponsor

Alberto Dal Molin

Other

Collaborators

  • Azienda Ospedaliero Universitaria Maggiore della Carita

Registry information

Official study title

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

Acronym: INTERCOACH

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 29, 2024
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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