Heart FailureINTERCOACHNCT06285565
A Nurse-led Coaching Programme With Telemonitoring in Heart Failure
A study testing Nurse-led telephone coaching intervention with home telemonitoring of vital signs in people with Heart Failure and Telemonitoring, run by Alberto Dal Molin at 2 sites in Italy.
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'… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure, Telemonitoring, Hospitalizations
- What is being tested?
- Nurse-led telephone coaching intervention with home telemonitoring of vital signs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesItaly
- Study dates
- 17 Sep 2024to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Italy2 sites
Azienda Ospedaliero-Universitaria maggiore della Carità di Novara
Novara, Novara, 28100
Università del Piemonte Orientale Amedeo Avogadro
Novara, Novara, 28100
About this study
Official title: A Nurse-led Coaching Programme With Telemonitoring in Heart Failure: Protocol for a Randomized Controlled Feasibility Study
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?
Read more
Participants will follow a combined intervention consisting of:
- pre-discharge educational meeting;
- telephone nurse-led coaching sessions;
- 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
- Conditions
- Heart Failure, Telemonitoring, Hospitalizations, Feasibility, Mentoring
- Being tested
- Nurse-led telephone coaching intervention with home telemonitoring of vital signs
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led telephone coaching intervention with home telemonitoring of vital signsCombination 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
| Study group | Role | What they receive |
|---|---|---|
| Nurse-led supported group | Experimental | 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. Receives: Combination Product: Nurse-led telephone coaching intervention with home telemonitoring of vital signs |
| Controlled group | No intervention | The controlled group will receive usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
the proportion of patients who agreed to participate relative to those who fulfilled the inclusion criteria.
Measured: 6 months
Retention rate
the proportion of patients who complete the study and those who consent to participate
Measured: 6 months
Adherence to the coaching intervention
the number of coaching phone calls scheduled and actualized
Measured: 4 months.
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
Measured: 4 months.
Completeness of data collection
number of returned questionnaires.
Measured: baseline, after 3 and 6 months
Secondary outcomes (12)
90- and 180-day all-cause hospital readmissions
Measured: Data collection is planned at 3 and 6 months.
90- and 180-day heart failure-related hospital readmissions
Measured: Data collection is planned at 3 and 6 months.
90- and 180-day Emergency Departments visits
Measured: Data collection is planned at 3 and 6 months.
90- and 180-day General Practioner visits
Measured: Data collection is planned at 3 and 6 months.
90- and 180-day oupatient visits
Measured: Data collection is planned at 3 and 6 months.
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
Measured: Data collection is planned at baseline, 3 and 6 months.
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
Measured: Data collection is planned at baseline, 3 and 6 months.
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
Measured: Data collection is planned at baseline, 3 and 6 months.
Anxiety (Hamilton Anxiety Scale )
The detection of anxiety symptoms (psychological and somatic).
Measured: Data collection is planned at baseline, 3 and 6 months.
Depression (Geriatric Depression Scale)
The detection of depressive symptoms of the elderly
Measured: Data collection is planned at baseline, 3 and 6 months.
Heart Failure Somatic Perception Scale v.3 (HFSPS)
The detecion of somatic symptoms of the disease
Measured: Data collection is planned at baseline, 3 and 6 months.
Mortality
Measured: Data collection is planned at 3 and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start17 Sep 2024
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel, open-label randomized controlled feasibility study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alberto Dal Molin
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Responsible party
- Sponsor-investigator, Alberto Dal Molin, Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Investigators
- INES BASSO, Dr, Study chair, Università degli Studi del Piemonte Orientale Amedeo Avogadro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285565
- Sponsor's protocol ID
- CE390/2023
- Acronym
- INTERCOACH
- Status last verified
- Mar 2026
- First submitted
- 6 Feb 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nurse-led Coaching Programme With Telemonitoring in Heart Failure: Protocol for a Randomized Controlled Feasibility Study
- ClinicalTrials.gov ID
- NCT06285565
- Acronym / sponsor ID
- INTERCOACH / CE390/2023
- Conditions
- Heart Failure, Telemonitoring, Hospitalizations, Feasibility, Mentoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Alberto Dal MolinUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- pre-discharge educational meeting;
- telephone nurse-led coaching sessions;
- 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel, open-label randomized controlled feasibility study
| Arm | Type | Receives |
|---|---|---|
| Nurse-led supported group | Experimental | Combination Product: Nurse-led telephone coaching intervention with home telemonitoring of vital signsA 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. |
| Controlled group | No intervention | –The controlled group will receive usual care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led telephone coaching intervention with home telemonitoring of vital signsIn 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 | Combination product | Nurse-led supported group |
Primary outcome
Recruitment rate
Time frame: 6 months
the proportion of patients who agreed to participate relative to those who fulfilled the inclusion criteria.
Retention rate
Time frame: 6 months
the proportion of patients who complete the study and those who consent to participate
Adherence to the coaching intervention
Time frame: 4 months.
the number of coaching phone calls scheduled and actualized
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
Completeness of data collection
Time frame: baseline, after 3 and 6 months
number of returned questionnaires.
12 secondary outcomes
90- and 180-day all-cause hospital readmissions
Time frame: Data collection is planned at 3 and 6 months.
90- and 180-day heart failure-related hospital readmissions
Time frame: Data collection is planned at 3 and 6 months.
90- and 180-day Emergency Departments visits
Time frame: Data collection is planned at 3 and 6 months.
90- and 180-day General Practioner visits
Time frame: Data collection is planned at 3 and 6 months.
90- and 180-day oupatient visits
Time frame: Data collection is planned at 3 and 6 months.
Self-care capacity (Self-Care of Heart Failure Index )
Time frame: Data collection is planned at baseline, 3 and 6 months.
Self Care - Self-Efficacy Scale
Time frame: Data collection is planned at baseline, 3 and 6 months.
Quality of life (SF-12 scale)
Time frame: Data collection is planned at baseline, 3 and 6 months.
Anxiety (Hamilton Anxiety Scale )
Time frame: Data collection is planned at baseline, 3 and 6 months.
Depression (Geriatric Depression Scale)
Time frame: Data collection is planned at baseline, 3 and 6 months.
Heart Failure Somatic Perception Scale v.3 (HFSPS)
Time frame: Data collection is planned at baseline, 3 and 6 months.
Mortality
Time frame: Data collection is planned at 3 and 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
INES BASSO, Dr study chair
Università degli Studi del Piemonte Orientale Amedeo Avogadro
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led telephone coaching intervention with home telemonitoring of vital signs in people with Heart Failure and Telemonitoring, run by Alberto Dal Molin at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.