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Heart Failure Virtual Ward Research Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Ireland
Portiuncula University Hospital
RECRUITING
Ballinasloe
Contact Information
Primary
David Tiernan, MD
david.tiernan@universityofgalway.ie
+353 861735800
Backup
Nuria Farre, MD, PhD
nuria.farre@hse.ie
+35390 964 8200
Time Frame
Start Date: 2024-10-18
Estimated Completion Date: 2027-05
Participants
Target number of participants: 346
Treatments
Active_comparator: 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
Experimental: 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).
Related Therapeutic Areas
Sponsors
Collaborators: Health Service Executive, Ireland
Leads: National University of Ireland, Galway, Ireland

This content was sourced from clinicaltrials.gov