RecruitingNot ApplicableNCT06620653

Heart Failure Virtual Ward Research Study


Sponsor

National University of Ireland, Galway, Ireland

Enrollment

346 participants

Start Date

Oct 18, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria9

  • 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.

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Interventions

OTHERTelemonitoring

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.

OTHERStandard 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.


Locations(1)

Portiuncula University Hospital

Ballinasloe, Galway, Ireland

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NCT06620653


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