Continuum: Digital Health to Manage Heart Failure Outpatients
Heart Failure, Chronic Heart Failure
About this trial
This is an interventional health services research trial for Heart Failure focused on measuring Digital health, Digital therapeutics, Software as medical device, Remote patient management, Telemonitoring, Mobile health, Guideline-Directed Medical Therapy
Eligibility Criteria
HFC-IN
Inclusion Criteria:
- HF diagnostic
- NYHA 2 or +
- Active follow-up in heart failure clinic
- Ability to use mobile app (or with caregiver's help)
- And one of the following
- New HF diagnosis (<3 months)
- Emergency visit or recent hospitalization with decompensated HF (<6months)
- Increase of >50% diuretic dose, new diuretic or IV diuretic (last 3 months)
- Active heart failure follow-up 2 times in the last 3 months
HFC-OUT
Inclusion Criteria:
- HF diagnostic
- Ability to use mobile app (or with caregiver's help)
- No active follow-up in heart failure clinic or in the waiting list of one
Exclusion Criteria for HFC-IN and HFC-OUT:
- Active hospitalization at randomization or anticipated in the next 2 weeks
- Incapable or minor patient
- History of non-adherence or treatment refusal
- Alcohol or drugs abuse
- Active major depression without caregiver
- Global prognosis < 3months
- Active dialysis or on waiting list
- Heart transplant or mechanical heart
- Severe pulmonary disease with oxygen use or pulmonary transplant waiting list or recurrent pleural drainage
- Severe chronic cirrhosis or hepatic transplant waiting list or recurrent ascites drainage
- Percutaneous or surgical intervention in last 30 days or planned in next 3 months
- Pregnancy
- Active follow-up in another study
Sites / Locations
- CRCHUM
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
For patients followed in a heart failure clinic (HFC), intervention HFC-IN
For patients followed in a HFC, control HFC-IN
For patients not followed in a HFC, intervention HFC-OUT
For patients not followed in a HFC, control HFC-OUT
Use of the full Continuum solution: remote patient monitoring and digital therapeutics over a period of 12 weeks
Standard of care for the follow-up, no use of remote monitoring or digital therapeutics for the first 12 weeks. After 12 weeks, option is given to the patient to use the full Continuum solution for another period of 12 weeks.
Use of part of the Continuum solution: the patient will use a mobile application to enter her/his data but no remote monitoring is performed. Digital therapeutics are used for the healthcare professionals.
Standard of care for the follow-up, no use of a mobile application or digital therapeutics for the first 12 weeks. After 12 weeks, option is given to the patient to use the mobile app and digital therapeutics are activated for another period of 12 weeks.