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)

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.

Study Overview

• Status: Recruiting
• Conditions: Frailty Syndrome; Caregiver Burden for Those Who Care for Adults With Impaired Functional Status
• Intervention / Treatment: Other: Caregivers supporting vulnerable patients and using the MyMonka solution.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Camilla GERLIER, Doctor; Phone Number: 01·44·12·80·23; Email: cgerlier@ghpsj.fr
• Study Contact Backup: Name: Célia MAMMA; Phone Number: 01·44·12·32·54; Email: cmamma@ghpsj.fr

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Hopital Paris Saint-Joseph
    • Contact: Camille GERLIER; Phone Number: 01·44·12·80·23; Email: cgerlier@ghpsj.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient and caregiver dyad experiencing the MyMonka solution in real-life conditions	Other: Caregivers supporting vulnerable patients and using the MyMonka solution.; Testing of the MyMonka solution; Response to questionnaires during the follow-up period on quality of life and burden measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in the score on the 12-item Zarit Burden Interview questionnaire (ZBI-12, Appendix 1), measured on days 0, 30, and 90, among family caregivers participating in the study.	Days 0, 30 and 90

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in the physical and mental quality of life of caregivers, expressed as the difference between SF-12 questionnaire scores at baseline, on day 30, and on day 90.	Days 30 and 90
Change in patient frailty expressed as the difference between the Clinical Frailty Scale score obtained at inclusion and on day 90.	Days 0 and 90
Percentage of people affected by the following adverse events within three months of returning home: new emergency room visits, unscheduled hospitalizations and their duration, falls, home hospitalizations, institutionalization, and death.	Days 90
Evaluation of the use, acceptability, usability, and impact of the Monka digital solution for caregivers through intervention tracking, algorithm-based vulnerability assessment, and standardized questionnaires over a 90-day period.	Days 0 and 90

Collaborators and Investigators

• Sponsor: Fondation Hôpital Saint-Joseph
• Collaborators: Monka Care

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2025
• Primary Completion (Estimated): March 12, 2027
• Study Completion (Estimated): March 12, 2027

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: January 9, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Burden; Frailty syndrome; Non-professional caregiver
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Frailty
• Other Study ID Numbers: 782_RW-HOMECARE; ID RCB : 2025-A02182-47 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No