Heart Failure Virtual Ward Research Study

NCT06620653 | Recruiting DMC

• 1 other identifier: Heart Failure Virtual Ward
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Reduction in re-admission rates

  Whether a follow-up with virtual wards reduces HF hospitalisation at three whether a follow up with virtual wards reduces HF hospitalisation at three months follow-up

  three months

Secondary Outcomes (2)

• All cause mortality

  12 months

• Financial Cost of virtual ward in comparison to the standard care

  3 months

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

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

Other: Standard Care

Telemonitoring

EXPERIMENTAL

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).

Other: Telemonitoring

Interventions

Telemonitoring 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.

Telemonitoring

Standard Care 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.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead
• Health Service Executive, Ireland: collaborator

Study Sites (1)

Portiuncula University Hospital

Ballinasloe, Galway, H53 T971, Ireland

RECRUITING

Related Publications (1)

• 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.

  PMID: 16863893 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Derek O'Keeffe, MD, PhD

  Galway University Hospitals/University of Galway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Tiernan, MD

CONTACT

+353 861735800; david.tiernan@universityofgalway.ie

Nuria Farre, MD, PhD

CONTACT

+35390 964 8200; nuria.farre@hse.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: the participants will be randomised using REDCAP software but there will be no masking performed
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised controlled trial. half of the participants will be in the tele monitoring group while the other half will be in the current standard of care group

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: October 1, 2024
• Study Start: October 18, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)