OPTIMUM Study of Remote Patient Monitoring in Ambulatory Heart Failure Care (NCT07439081) | Clinical Trial Compass
CompletedNot Applicable
OPTIMUM Study of Remote Patient Monitoring in Ambulatory Heart Failure Care
France504 participantsStarted 2021-01-01
Plain-language summary
Heart failure is a leading cause of hospitalization and readmission, particularly among older adults with multiple comorbidities. Traditional outpatient follow-up may be insufficient to detect early clinical deterioration in this vulnerable population. Remote patient monitoring (RPM) using non-invasive symptom and weight tracking has been proposed to enhance ambulatory care, but its effectiveness appears to depend on integration within structured care pathways.
The OPTIMUM study evaluated the real-world implementation of an integrated ambulatory heart failure care pathway combining non-invasive RPM with multidisciplinary follow-up in routine clinical practice. Patients enrolled after a recent heart failure hospitalization were managed using the Satelia® Cardio monitoring system, nurse-led therapeutic education, and a planned cardio-geriatric day-hospital reassessment. The study aimed to describe pathway implementation and assess associations with rehospitalizations, mortality, alert activity, and patient and healthcare professional satisfaction in an older, frail population.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years
* Diagnosis of heart failure
* Hospitalization for acute heart failure or a cardiac cause OR outpatient evaluation with a history of heart-failure hospitalization within the previous 12 months
* Enrollment into the OPTIMUM ambulatory heart failure care pathway
* Ability to provide informed consent
* Agreement to participate in remote patient monitoring
Exclusion Criteria:
* Inability to provide informed consent
* Refusal to participate in remote patient monitoring or the OPTIMUM care pathway
* Physical, cognitive, or psychological limitations incompatible with use of the remote monitoring system
* Treating clinician judged that adherence to telemonitoring would be insufficient
* Presence of a non-cardiac comorbidity associated with an estimated life expectancy of less than 12 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was specifically measuring cardiac rehospitalizations in heart failure patients — do you think my current risk of being rehospitalized makes me a good candidate to discuss what they found?
2Since this was a remote patient monitoring study for ambulatory heart failure care, can you tell me whether the kind of at-home monitoring they tested is something that could realistically fit into my daily routine and living situation?
3The trial has already completed — have the results been published yet, and if so, what did they show about whether remote monitoring actually reduced hospital readmissions for heart failure patients?
4Given that this study focused on ambulatory heart failure care, does my current stage or severity of heart failure match the type of patients who were enrolled, or would a different approach be more appropriate for me?
5How does the remote monitoring approach studied here compare to the standard follow-up care I would receive anyway, and is there any reason to think one would be better suited to managing my specific heart failure situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Cardiac Rehospitalizations
Timeframe: 1 year before enrollment and 1 year after enrollment