Feasibility Study on the Implementation of a Program to Facilitate the Return Home of Patients With Heart Failure Following Hospitalization, Led by a Coordinated Multidisciplinary Team Based on the "Team-based Care" Model

A study testing Intervention Arm - TEAM-IC in people with Heart Failure, run by Sant'Innovation at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial summary

Heart failure is a common heart condition that often leads to hospital stays and repeat readmissions. When patients leave the hospital, coordinating patient care between the hospital and the local healthcare team (family doctor, nurses, cardiologist) can be difficult, and gaps in this coordination can lead to… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure
What is being tested?: Intervention Arm - TEAM-IC
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteFrance
Study dates: 4 Oct 2026to Dec 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, age > 18 years with no upper age limit;
Hospitalized for heart failure;
Discharge home anticipated within 7 days of enrollment;
Signed and dated informed consent;
Resident within the GHT Centre Franche-Comté and within a maximum of one hour by road from one of the two enrolling centers.

Who cannot join

Needfor a heart transplant or ventricular assist device;
Any severe valvular heart disease that could benefit from surgical intervention during the course of the study;
Patients with a life expectancy of less than 3 months;
A person subject to a legal protection measure, involuntary psychiatric care, unable to give consent, to follow instructions, or to comply with follow-up procedures;
Any other medical condition that would put the patient at risk or could influence the study results
Not affiliated with or not a beneficiary of a French social security scheme;

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Subject in the exclusion period of another study or listed in the "national register of volunteers" ("fichier national des volontaires");
Patient currently enrolled in an ongoing interventional clinical research study on heart failure management (risk of interference);
Patient already benefiting from a home discharge program other than the PRADO program.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site

MSP " Sant'Innovation " de Palente
Besançon

Other trials in France

About this study

This study, called TEAM-IC, tests a new way of organizing the return home after a hospital stay for heart failure. In this new approach, a dedicated "care coordination nurse" based in a local primary care health center works closely with the patient's usual caregivers and with the hospital team to support the patient during the first three months after discharge. This is compared to the existing standard program (PRADO-IC) currently used in France.

Hypothesis: The investigators believe that organizing the return home around a coordinating nurse embedded in a local health center, with support tailored to each patient's level of frailty, will lead to better follow-up and better care for heart failure patients than the current standard program.

Before testing whether this approach actually improves health outcomes in a larger trial, this study first aims to find out whether such a program is realistic and workable in practice, for example, whether patients and healthcare professionals are willing to take part, whether the organization runs smoothly, and whether the study procedures can be followed as planned.

Conditions: Heart Failure
Being tested: Intervention Arm - TEAM-IC
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intervention Arm - TEAM-ICOther
A 3-month post-discharge care pathway for heart failure patients, coordinated by a dedicated care-pathway support nurse (IAP) based in a resource primary care health center (MSP), working alongside the patient's own GP and community nurse. Before discharge, the IAP assesses frailty (SEGA-A scale) and non-adherence risk (SPUR), then stratifies patients into 3 follow-up intensity levels. The IAP registers patients on a regional hospital-community coordination platform (eTICSS), offers telemonitoring of weight, blood pressure and heart failure warning signs, and liaises with the hospital's advanced-practice nurse in cardiology. The GP and community nurse receive personalized recommendations, online training modules, and support for administrative and social care referrals. Unlike the PRADO-IC control arm, the intervention adds an upstream frailty/adherence assessment and a primary-care-based coordinating nurse linked directly to the hospital team.

Study groups in NCT07849361
Study group	Role	What they receive
Intervention Arm - TEAM-IC	Experimental	Patients randomized to this arm receive the TEAM-IC pathway following hospitalization for heart failure. Before discharge, a care-pathway support nurse (IAP), based in a resource primary care health center (MSP), assesses frailty (SEGA-A scale), non-adherence risk (SPUR), and quality of life (KCCQ-12), then stratifies the patient into one of three follow-up intensity levels. The patient is registered on a regional care-coordination platform (eTICSS) and offered telemonitoring of weight, blood pressure, and heart failure warning signs. The patient's GP and community nurse are informed, receive personalized recommendations and access to online training modules, and are supported by the IAP for 3 months post-discharge, including help with administrative/social care referrals and a cardiology advanced-practice nurse consultation at 1 month. The GP's role as primary caregiver is not modified; the IAP provides additional coordination support alongside standard care. Receives: Other: Intervention Arm - TEAM-IC
Control Arm - PRADO	No intervention	Patients randomized to this arm receive the standard PRADO-IC discharge program managed by the French national health insurance (CPAM), with no TEAM-IC coordination support. Before discharge, the IAP still assesses frailty (SEGA-A), non-adherence risk (SPUR), and quality of life (KCCQ-12), but these results do not trigger any specific follow-up actions in this arm. The patient is offered standard telemonitoring and/or advanced-practice nurse (IPA) follow-up as usually available. Home nursing visits and clinical monitoring follow the usual PRADO-IC protocol for 3 months. At month 3, the study team collects outcome data for comparison with the intervention arm: rehospitalization, non-hospitalized decompensation episodes (EPOF signs), NYHA class, BNP level, mortality, guideline-recommended drug prescriptions, KCCQ score, healthcare utilization, and satisfaction questionnaires from the patient, GP, and community nurse

What is being measured

The primary outcome is the main question the study is designed to answer.

Organizational feasibility: proportion of study procedures completed as planned
Percentage of scheduled study procedures (appointments and data collection visits) carried out as planned in the TEAM-IC care pathway, among all scheduled procedures. As this is a pilot feasibility study, no statistical hypothesis testing is planned; results will be reported descriptively to inform the design of a future full-scale trial.
Measured: From discharge to 3 months after discharge
Acceptability: inclusion rate among eligible patients
Percentage of eligible patients who are included in the study (number of included participants divided by number of eligible patients). The numbers of potentially eligible, eligible, not contacted, refusing, and included patients will be reported in the participant flow chart. Results will be reported descriptively.
Measured: At eligibility assessment, during the index hospitalization for heart failure
Protocol adherence: completeness of collected data
Percentage of expected data items actually collected, among all data items planned by the protocol. Results will be reported descriptively.
Measured: From inclusion to 3 months after discharge
Protocol adherence: attrition rate
Percentage of included participants who leave the study before the end of follow-up, whether through consent withdrawal, non-adherence to the program, or loss to follow-up. Results will be reported descriptively.
Measured: From inclusion to 3 months after discharge
Adherence to the projected study timeline: actual versus planned enrollment
Number of participants actually enrolled, expressed as a percentage of the number planned at the corresponding milestone of the study timeline. Results will be reported descriptively.
Measured: At enrollment, during the index hospitalization for heart failure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Oct 2026Dec 2027

First posted30 Sep 2026
Study start4 Oct 2026 (estimated)
Primary completionDec 2027 (estimated)
Study completionDec 2027 (estimated)

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
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07849361
Sponsor's protocol ID: AAP_ResP-Ir_2024
Acronym: TEAM-IC
Status last verified: Sep 2026
First submitted: 24 Sep 2026
Last updated: 5 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility Study on the Implementation of a Program to Facilitate the Return Home of Patients With Heart Failure Following Hospitalization, Led by a Coordinated Multidisciplinary Team Based on the "Team-based Care" Model
ClinicalTrials.gov ID: NCT07849361
Acronym / sponsor ID: TEAM-IC / AAP_ResP-Ir_2024
Conditions: Heart Failure
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: Sant'InnovationUniversity, hospital or other
Collaborators: Direction Générale de l'Offre de Soin (DGOS), FeMaSCo-BFC, Agence Régionale de Santé - Bourgogne Franche Comté
Study start: 4 Oct 2026 (estimated)
Primary completion: Dec 2027 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 30 Sep 2026 (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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention Arm - TEAM-IC	Experimental	Other: Intervention Arm - TEAM-ICPatients randomized to this arm receive the TEAM-IC pathway following hospitalization for heart failure. Before discharge, a care-pathway support nurse (IAP), based in a resource primary care health center (MSP), assesses frailty (SEGA-A scale), non-adherence risk (SPUR), and quality of life (KCCQ-12), then stratifies the patient into one of three follow-up intensity levels. The patient is registered on a regional care-coordination platform (eTICSS) and offered telemonitoring of weight, blood pressure, and heart failure warning signs. The patient's GP and community nurse are informed, receive personalized recommendations and access to online training modules, and are supported by the IAP for 3 months post-discharge, including help with administrative/social care referrals and a cardiology advanced-practice nurse consultation at 1 month. The GP's role as primary caregiver is not modified; the IAP provides additional coordination support alongside standard care.
Control Arm - PRADO	No intervention	–Patients randomized to this arm receive the standard PRADO-IC discharge program managed by the French national health insurance (CPAM), with no TEAM-IC coordination support. Before discharge, the IAP still assesses frailty (SEGA-A), non-adherence risk (SPUR), and quality of life (KCCQ-12), but these results do not trigger any specific follow-up actions in this arm. The patient is offered standard telemonitoring and/or advanced-practice nurse (IPA) follow-up as usually available. Home nursing visits and clinical monitoring follow the usual PRADO-IC protocol for 3 months. At month 3, the study team collects outcome data for comparison with the intervention arm: rehospitalization, non-hospitalized decompensation episodes (EPOF signs), NYHA class, BNP level, mortality, guideline-recommended drug prescriptions, KCCQ score, healthcare utilization, and satisfaction questionnaires from the patient, GP, and community nurse

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male or female, age > 18 years with no upper age limit;
Hospitalized for heart failure;
Discharge home anticipated within 7 days of enrollment;
Signed and dated informed consent;
Resident within the GHT Centre Franche-Comté and within a maximum of one hour by road from one of the two enrolling centers.

Key exclusion criteria (9 listed)

Needfor a heart transplant or ventricular assist device;
Any severe valvular heart disease that could benefit from surgical intervention during the course of the study;
Patients with a life expectancy of less than 3 months;
A person subject to a legal protection measure, involuntary psychiatric care, unable to give consent, to follow instructions, or to comply with follow-up procedures;
Any other medical condition that would put the patient at risk or could influence the study results

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
Intervention Arm - TEAM-ICA 3-month post-discharge care pathway for heart failure patients, coordinated by a dedicated care-pathway support nurse (IAP) based in a resource primary care health center (MSP), working alongside the patient's own GP and community nurse. Before discharge, the IAP assesses frailty (SEGA-A scale) and non-adherence risk (SPUR), then stratifies patients into 3 follow-up intensity levels. The IAP registers patients on a regional hospital-community coordination platform (eTICSS), offers telemonitoring of weight, blood pressure and heart failure warning signs, and liaises with the hospital's advanced-practice nurse in cardiology. The GP and community nurse receive personalized recommendations, online training modules, and support for administrative and social care referrals. Unlike the PRADO-IC control arm, the intervention adds an upstream frailty/adherence assessment and a primary-care-based coordinating nurse linked directly to the hospital team.	Other	Intervention Arm - TEAM-IC

Primary outcome

Organizational feasibility: proportion of study procedures completed as planned
Time frame: From discharge to 3 months after discharge
Percentage of scheduled study procedures (appointments and data collection visits) carried out as planned in the TEAM-IC care pathway, among all scheduled procedures. As this is a pilot feasibility study, no statistical hypothesis testing is planned; results will be reported descriptively to inform the design of a future full-scale trial.
Acceptability: inclusion rate among eligible patients
Time frame: At eligibility assessment, during the index hospitalization for heart failure
Percentage of eligible patients who are included in the study (number of included participants divided by number of eligible patients). The numbers of potentially eligible, eligible, not contacted, refusing, and included patients will be reported in the participant flow chart. Results will be reported descriptively.
Protocol adherence: completeness of collected data
Time frame: From inclusion to 3 months after discharge
Percentage of expected data items actually collected, among all data items planned by the protocol. Results will be reported descriptively.
Protocol adherence: attrition rate
Time frame: From inclusion to 3 months after discharge
Percentage of included participants who leave the study before the end of follow-up, whether through consent withdrawal, non-adherence to the program, or loss to follow-up. Results will be reported descriptively.
Adherence to the projected study timeline: actual versus planned enrollment
Time frame: At enrollment, during the index hospitalization for heart failure
Number of participants actually enrolled, expressed as a percentage of the number planned at the corresponding milestone of the study timeline. Results will be reported descriptively.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
Individual participant dataSharing planned: No

Related trials for Heart Failure

Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Intervention Arm - TEAM-IC in people with Heart Failure, run by Sant'Innovation at 1 site in France.

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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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?

This study is still under way. Results are not available in the source record yet.

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?

Organizational feasibility: proportion of study procedures completed as planned (time frame: From discharge to 3 months after discharge). 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?

On the ClinicalTrials.gov record for NCT07849361.

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 Oct 2026.