Health TrialsbyHealthPanel

Heart Failure Virtual Ward Research Study

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational University of Ireland, Galway, Ireland

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Telemonitoring

    Other intervention

    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.

  • Standard Care

    Other intervention

    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.

Treatment groups

346 Participants
are divided into 2 treatment groups
Group A: Standard CareActive comparator 1 intervention
Group B: TelemonitoringExperimental treatment 1 intervention

Trial outcomes

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

Time frame
three months

Secondary outcomes

1

All cause mortality

Whether HF virtual wards reduces all cause mortality

Time frame
12 months
2

Financial Cost of virtual ward in comparison to the standard care

Analysis of the financial implications of using the virtual heart failure ward in comparison to the cost of standard heart failure care

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University of Ireland, Galway, Ireland

Lead sponsor

Health Service Executive, Ireland

Collaborator

Source ClinicalTrials.gov
Apply now