Status:

UNKNOWN

A Digital Solution for Patients With Heart Failure

Lead Sponsor:

Sidekick Health

Collaborating Sponsors:

Landspitali University Hospital

Conditions:

Heart Failure

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The study aim is to determine whether a 12-month digitally delivered behaviour change solution for patients with heart failure improves symptom frequency, mental health, quality of life, medication ad...

Detailed Description

Heart Failure (HF) is one of the most common causes of morbidity and mortality in developed countries with a prevalence rate of 4.2% of the adult population and 11.8% among people ≥60 years of age. Wo...

Eligibility Criteria

Inclusion

  • Adults with confirmed congestive HF registered at the outpatient heart failure clinic at the Landspitali University Hospital
  • Participants should be on one of these medications for heart failure treatment: angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blocker (ARB) inhibitors, or Angiotensin Receptor-Neprilysin Inhibitor
  • Participants with all stages of HF will be included (NYHA classes I-IV)
  • Started their medical HF treatment at least 1 month prior to study enrollment
  • Participants should be willing and able to comply with study procedures and attend the scheduled visits
  • Capacity to consent to informed consent

Exclusion

  • HF due to reversible causes (e.g., myocarditis) or severe aortic valve stenosis
  • Not owning a smartphone compatible with the Sidekick Health digital solution
  • Not knowing how to operate a smartphone
  • Moderate to severe dementia
  • Unable to understand written and verbal instructions in Icelandic.
  • estimated Glomerular Filtration Rate (eGFR) \<15 ml/min
  • Planned dialysis in the next 6 months
  • Planned cardiac transplant surgery
  • Active drug/alcohol abuse
  • Other serious illness (e.g., cancer, endocarditis)

Key Trial Info

Start Date :

January 15 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2023

Estimated Enrollment :

174 Patients enrolled

Trial Details

Trial ID

NCT05193344

Start Date

January 15 2022

End Date

December 31 2023

Last Update

February 23 2023

Active Locations (1)

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1

Landspitali University Hospital

Reykjavik, Iceland