Médipôle Hôpital Mutualiste
Lyon, Auvergne-Rhône-Alpes, 69100, France
NCT Number: NCT07439081
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.
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Notify Me18 year and older
All sexes
Observational
Lyon, Auvergne-Rhône-Alpes, 69100, France
Heart failure (HF) is a major cause of hospitalization and rehospitalization among older adults and represents a substantial burden for healthcare systems. Many readmissions occur after discharge for acute heart failure (AHF), often related to delayed recognition of worsening symptoms. While non-invasive remote patient monitoring (RPM) has been proposed as a strategy to extend surveillance into the home setting, previous studies suggest that monitoring alone may be insufficient without integration into structured, multidisciplinary care.
OPTIMUM was a prospective, single-center, observational cohort study designed to evaluate the implementation of a structured ambulatory HF care pathway incorporating non-invasive RPM in routine clinical practice. The study was conducted at Médipôle Hôpital Mutualiste in Lyon, France. Adult patients with a recent hospitalization for acute heart failure, or with a history of AHF hospitalization within the prior 12 months, were enrolled into the OPTIMUM care pathway and followed prospectively.
The care pathway combined several coordinated components:
Patients were managed according to routine clinical practice, and no experimental interventions were introduced. The study used a pre-post design comparing outcomes during the 12 months before enrollment with those during the 12 months after enrollment in the pathway. The primary outcome was the number of cardiac rehospitalizations. Secondary outcomes included all-cause hospitalizations, mortality up to two years, frequency and distribution of RPM alerts, and patient and healthcare professional satisfaction. Health-related quality of life and frailty measures were also collected descriptively.
OPTIMUM aimed to provide real-world evidence on how RPM can be operationalized within an integrated ambulatory HF care model, particularly in an older, frail population often underrepresented in clinical trials.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A non-invasive remote patient monitoring system based on regular patient-reported symptom questionnaires and body weight measurements. A built-in algorithm generates color-coded alerts (green, orange, red) to support early detection of potential heart failure decompensation. Alerts are reviewed by healthcare professionals as part of routine care.
Time frame: 1 year before enrollment and 1 year after enrollment
Total number of hospital admissions with a primary cardiac diagnosis (ICD-10 codes I50.x) occurring during the 12 months following enrollment in the ambulatory care pathway, compared descriptively with the 12 months preceding enrollment.
Time frame: 1 year before enrollment and 1 year after enrollment
Total number of hospital admissions for any cause during the 12 months following enrollment compared with the 12 months preceding enrollment.
Time frame: Up to 24 months after enrollment
Death from any cause among enrolled participants
Time frame: Up to 24 months after enrollment
Death attributed to cardiovascular causes based on clinical records.
Time frame: 1 year
Frequency and distribution of color-coded alerts (green, orange, red) generated by the Satelia® Cardio remote monitoring algorithm during follow-up.
Time frame: At the end of follow up or the study period
Self-reported satisfaction and healthcare professional satisfaction with integrated ambulatory care pathway measured using a 10-point Likert scale questionnaire
Médipôle Lyon-Villeurbanne
Other
OPTIMUM: OPTIMisation du Parcours de Soins du Patient Insuffisant Cardiaque Chronique
Acronym: OPTIMUM
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