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