Clinical trial NCT06620653: Heart Failure Virtual Ward Research Study
Official title: Heart Failure Virtual Ward Research Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
Collaborators: name: Health Service Executive, Ireland
First posted: 2024-10-01
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Reduction in re-admission rates
timeFrame: three months
Secondary outcomes:
measure: All cause mortality
timeFrame: 12 months
measure: Financial Cost of virtual ward in comparison to the standard care
timeFrame: 3 months
Other outcomes:
Locations:
city: Ballinasloe
country: Ireland
facility: Portiuncula University Hospital
state: Galway
Study officials:
affiliation: Galway University Hospitals/University of Galway
name: Derek O&amp;amp;amp;amp;#39;Keeffe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.