Clinical trial NCT06285565: A Nurse-led Coaching Programme With Telemonitoring in Heart Failure
Official title: A Nurse-led Coaching Programme With Telemonitoring in Heart Failure: Protocol for a Randomized Controlled Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Telemonitoring
Hospitalizations
Feasibility
Mentoring
Lead sponsor: Università degli Studi del Piemonte Orientale Amedeo Avogadro
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero Universitaria Maggiore della Carita
First posted: 2024-02-29
Enrollment: 45
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel, open-label randomized controlled feasibility study
Primary purpose: SUPPORTIVE_CARE

Brief 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 criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: 6 months
measure: Retention rate
timeFrame: 6 months
measure: Adherence to the coaching intervention
timeFrame: 4 months.
measure: Adherence to telemonitoring program
timeFrame: 4 months.
measure: Completeness of data collection
timeFrame: baseline, after 3 and 6 months
Secondary outcomes:
measure: 90- and 180-day all-cause hospital readmissions
timeFrame: Data collection is planned at 3 and 6 months.
measure: 90- and 180-day heart failure-related hospital readmissions
timeFrame: Data collection is planned at 3 and 6 months.
measure: 90- and 180-day Emergency Departments visits
timeFrame: Data collection is planned at 3 and 6 months.
measure: 90- and 180-day General Practioner visits
timeFrame: Data collection is planned at 3 and 6 months.
measure: 90- and 180-day oupatient visits
timeFrame: Data collection is planned at 3 and 6 months.
measure: Self-care capacity (Self-Care of Heart Failure Index )
timeFrame: Data collection is planned at baseline, 3 and 6 months.
measure: Self Care - Self-Efficacy Scale
timeFrame: Data collection is planned at baseline, 3 and 6 months.
measure: Quality of life (SF-12 scale)
timeFrame: Data collection is planned at baseline, 3 and 6 months.
measure: Anxiety (Hamilton Anxiety Scale )
timeFrame: Data collection is planned at baseline, 3 and 6 months.
measure: Depression (Geriatric Depression Scale)
timeFrame: Data collection is planned at baseline, 3 and 6 months.
measure: Heart Failure Somatic Perception Scale v.3 (HFSPS)
timeFrame: Data collection is planned at baseline, 3 and 6 months.
measure: Mortality
timeFrame: Data collection is planned at 3 and 6 months.
Other outcomes:
Locations:
city: Novara
country: Italy
facility: Azienda Ospedaliero-Universitaria maggiore della Carità di Novara
city: Novara
country: Italy
facility: Università del Piemonte Orientale Amedeo Avogadro
Study officials:
affiliation: Università degli Studi del Piemonte Orientale Amedeo Avogadro
name: INES BASSO, Dr
role: STUDY_CHAIR
References: