NCT07348081 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.
| NCT ID | NCT07348081 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Hôpital Saint-Joseph |
| Condition | Frailty Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-12-12 |
| Primary Completion | 2027-03-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-12-12 with a primary completion date of 2027-03-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07348081 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Frailty Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07348081 currently recruiting?
Yes, NCT07348081 is actively recruiting participants. Contact the research team at cgerlier@ghpsj.fr for enrollment information.
Where is the NCT07348081 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT07348081 clinical trial?
NCT07348081 is sponsored by Fondation Hôpital Saint-Joseph. The trial plans to enroll 100 participants.