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.
Recruiting now · Not applicable
Conditions studied: Frailty Syndrome, Caregiver Burden for Those Who Care for Adults With Impaired Functional Status
In brief
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.
Key facts
- Study ID
- NCT07348081
- Run by
- Fondation Hôpital Saint-Joseph
- People needed
- 100
- Starts
- 2025-12-12
- Expected to finish
- 2027-03-12
- Last updated by the study team
- 2026-01-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Hôpital Paris Saint-Joseph — Paris, France (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.