Real World Evidence to Assess the Value of a Digital Care Coordination and Monitoring Program for Supporting Caregivers of Adults Discharged From the Emergency Department. (RW-HOMECARE)

Fondation Hôpital Saint-Joseph

Status: Enrolling

Conditions: Caregiver Burden for Those Who Care for Adults With Impaired Functional Status; Frailty Syndrome

Treatments: Other: Caregivers supporting vulnerable patients and using the MyMonka solution.

Study type: Interventional

Funder types: Other

Identifiers

NCT07348081

ID RCB : 2025-A02182-47 (Other Identifier)

782_RW-HOMECARE

Details and patient eligibility

About

The RW-HOMECARE study is a prospective, longitudinal, real-world pilot trial designed to assess the impact of proposing the Monka digital solution to non-professional caregivers of patients discharged from emergency or short-stay units. The primary objective is to measure changes in caregiver burden using the ZBI-12 scale at baseline, 30 days, and 90 days. Secondary objectives include evaluating caregivers' physical and mental quality of life (SF-12), patient frailty (Clinical Frailty Scale), and the incidence of adverse events such as emergency visits, unplanned hospitalizations, falls, institutionalization, and death within 90 days. The study also examines the usability, acceptability, and satisfaction with Monka digital solution through standardized questionnaires, the correlation between algorithm-generated vulnerability scores and established measures, and reasons for non-adoption.

Eligible dyads (patient and caregiver) are recruited at discharge from emergency or short-stay units. After informed consent, caregivers receive free access to Monka digital solution for 3 months, along with a user guide. Follow-up assessments are conducted by phone at Day 30 and Day 90 (±14 days). All interventions by the coordinating nurse are tracked and analyzed quantitatively and qualitatively.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

FOR THE PATIENT

• Person aged 18 or over, treated in the Emergency Department or Emergency Beds
• Affiliated with Social Security
• Having an adult non-professional relative helping them with one or more activities of daily living
• Having a medical decision to return home within the next 72 hours
• Who has given their free, informed, and express consent FOR THE CAREGIVER
• Individuals aged 18 or older
• Who are non-professional caregivers as defined in Article L. 113-1-3 of the Social Action and Families Code, living with or separately from the person being cared for (20)
• Providing assistance to the patient with one or more activities of daily living, i.e., shopping, medical appointments, coordination of care, administrative tasks, and moral support
• Access to a cell phone, computer, or tablet with an internet connection
• Having given their free, informed, and express consent

Exclusion criteria

FOR THE PATIENT

• Non-French speakers
• People living in a medical institution or scheduled for institutionalization within the next 3 months
• People receiving home hospitalization (HAD) or palliative care at home
• People under legal protection, deprived of their liberty, or under legal guardianship (tutelage or curatelle) FOR THE CAREGIVER
• Non-French speakers
• People with cognitive or psychiatric disorders that prevent them from understanding and using the MONKA solution
• People under legal protection, deprived of their liberty, or under legal guardianship (tutelage or curatelle)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Patient and caregiver dyad experiencing the MyMonka solution in real-life conditions

Experimental group

Treatment:

Other: Caregivers supporting vulnerable patients and using the MyMonka solution.