Heart Failure Virtual Ward Research Study

NCT ID: NCT06620653

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 346 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-20
• Study Completion Date: 2026-05-31

Brief Summary

The main aim will be to evaluate whether a follow-up with virtual wards reduces HF hospitalisation at three months follow-up. Hospital admission will be defined as any hospital admission, or an emergency room stay of more than 24 h requiring IV diuretics.

The secondary objectives will be to evaluate whether this intervention reduces all-cause mortality, all-cause hospitalisation at three months, is cost-effectiveness, is associated with a higher percentage of prescription and dose of prognostic medication and improves the quality of life. To assess the potential long-term effects of the virtual wards follow-up, we will evaluate whether this intervention reduces all-cause mortality and HF hospitalisation at 6- and 12-months by a telephone call/virtual outpatients' appointment.

The study outcomes will be ascertained at each visit. Given the study design, it is impossible to assess the endpoints in a blinded manner. Clinical events during the study will be adjudicated by an operational committee whose members will be unaware of the group assignment.

Detailed Description

This is a randomized, controlled, multicentre, parallel-group trial in which we will consecutively include all patients over 18 years of age with a recent hospitalisation due to decompensated HF and randomise them to usual care vs. telemedicine follow-up. Any stay in the emergency department or ward for over 24 hours that required treatment with intravenous diuretic will be considered an hospitalisation.

The heart failure diagnosis will be made according to the 2021 ESC Heart Failure Guidelines.

The study will be registered at ClinicalTrials.gov. The study will be guided by good clinical practice (GCP), in accordance with the Declaration of Helsinki and the laws and regulations applicable in Ireland. Written approval from the appropriate Ethics Committees will be required, and each patient will provide written informed consent before enrolling in the study.

Patients will be recruited from the participant hospitals (Portiuncula University Hospital and Galway University Hospital).

Inclusion criteria: The study will include adult patients (≥ 18 years) with a recent hospitalisation. We will include all ranges of ejection fraction, and also patients with known and de novo heart failure.

The main exclusion criteria will be:

• Patients who decline to participate in the study.
• Patient in palliative care or with a life expectancy of less than one year.
• Patients referred to skilled nursing facilities or nursing homes at hospital discharge.
• Patients with planned intervention on the mitral or aortic valve during admission or scheduled early after discharge.
• Planned haemodialysis.
• Patients included in other randomized controlled trials.
• Patients who, at the investigator's discretion, are considered unable to participate in the study, mainly due to a previous history of non-compliance with medication and follow-up appointments, language barrier, or moderate or severe cognitive impairment without the support of a family member/caregiver.
• Patients with asymptomatic (NYHA class I) left ventricular dysfunction, usually in the setting of an acute myocardial infarction.

The lack of information technology (IT) literacy will not be an exclusion criterion.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard Care

All patients with a recent admission for decompensated heart failure are seen in a first face-to-face appointment within two weeks of discharge as per current 2021 ESC Heart Failure Guidelines.

The standard care group will receive the usual nurse lead structured follow up and patients in the usual care will have a face-to-face appointment at week 6 and 12, and all the other contacts will be phone calls or face-to-face

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: OTHER

patients with a recent admission for heart failureare seen in a first face-to-face appointment within two weeks of discharge as per current 2021 ESC Heart Failure Guidelines with face-to-face follow up at 6 and 12 weeks.

Telemonitoring

After the initial face-to-face appointment the telemonitoring group will have appointments at week 4 (phone call or videoconference), week 6 (videoconference), week 8 (phone call or videoconference) and week 12 (videoconference). In total, the patients will have 6 structured appointments.

Extra phone calls, videoconferences, and face-to-face visits will be made at any time, depending on the patient's needs, irrespective of the assigned group.

Patients assigned to the intervention group will receive a tablet (if the patients do not have a tablet, computer or smartphone), a weight scale and a blood pressure monitor. The patients will provide daily biometric data (weight, heart rate and blood pressure) and report symptoms through four questions to capture worsening symptoms of the cardiac condition.

The system will generate warning alarms (biometrics out of range or symptom reporting) and alerts (information related to the function of the household devices).

Group Type: EXPERIMENTAL

Telemonitoring

Intervention Type: OTHER

Patients assigned to the intervention group will receive a tablet (if the patients do not have a tablet, computer or smartphone), a weight scale and a blood pressure monitor. The patients will provide daily biometric data (weight, heart rate and blood pressure) and report symptoms through four questions to capture worsening symptoms of the cardiac condition.

Interventions

Telemonitoring

Patients assigned to the intervention group will receive a tablet (if the patients do not have a tablet, computer or smartphone), a weight scale and a blood pressure monitor. The patients will provide daily biometric data (weight, heart rate and blood pressure) and report symptoms through four questions to capture worsening symptoms of the cardiac condition.

Intervention Type: OTHER

Standard Care

patients with a recent admission for heart failureare seen in a first face-to-face appointment within two weeks of discharge as per current 2021 ESC Heart Failure Guidelines with face-to-face follow up at 6 and 12 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients (≥ 18 years) with a recent hospitalisation.
• Known ejection fraction and NYHA Class
• Known or de novo Heart Failure
• Patient or carer able to speak and understand English/Irish
• Willing to participate in the study.
• Within catchment area of the Saolta group.

Exclusion Criteria

• Patients who decline to participate in the study.
• Patient in palliative care or with a life expectancy of less than one year.
• Patients referred to skilled nursing facilities or nursing homes at hospital discharge.
• Patients with planned intervention on the mitral or aortic valve during admission or scheduled early after discharge.
• Planned haemodialysis.
• Patients included in other randomized controlled trials.
• Patients who, at the investigator's discretion, are considered unable to participate in the study, mainly due to a previous history of non- compliance with medication and follow-up appointments, language barrier, or moderate or severe cognitive impairment without the support of a family member/caregiver.
• Patients with asymptomatic (NYHA class I) left ventricular dysfunction, usually in the setting of an acute myocardial infarction.
• The lack of information technology (IT) literacy will not be an exclusion criterion.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health Service Executive, Ireland

OTHER

Sponsor Role: collaborator

National University of Ireland, Galway, Ireland

OTHER

Sponsor Role: lead

Responsible Party

Derek O'Keeffe

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Derek O'Keeffe, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Galway University Hospitals/University of Galway

Locations

Portiuncula University Hospital

Ballinasloe, Galway, Ireland

Countries

Ireland

Central Contacts

David Tiernan, MD

Role: CONTACT

david.tiernan@universityofgalway.ie

+353 861735800

Nuria Farre, MD, PhD

Role: CONTACT

nuria.farre@hse.ie

+35390 964 8200

Facility Contacts

Nuria Farre, MD, PhD

Role: primary

nuria.farre@hse.ie

+353090 964 8200

David Tiernan, MD

Role: backup

david.tiernan@universityofgalway.ie

+353861735800

Derek O'Keeffe, MD, PhD

Role: backup

References

Miller-Davis C, Marden S, Leidy NK. The New York Heart Association Classes and functional status: what are we really measuring? Heart Lung. 2006 Jul-Aug;35(4):217-24. doi: 10.1016/j.hrtlng.2006.01.003.

Reference Type: BACKGROUND

PMID: 16863893 (View on PubMed)

Other Identifiers

Heart Failure Virtual Ward

Identifier Type: -

Identifier Source: org_study_id