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

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-12
• Study Completion Date: 2027-03-12

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Caregivers supporting vulnerable patients and using the MyMonka solution.

Intervention Type: OTHER

Testing of the MyMonka solution; Response to questionnaires during the follow-up period on quality of life and burden measurement

Interventions

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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Monka Care

UNKNOWN

Sponsor Role: collaborator

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Paris Saint-Joseph

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Camilla GERLIER, Doctor

Role: CONTACT

cgerlier@ghpsj.fr

01·44·12·80·23

Célia MAMMA

Role: CONTACT

cmamma@ghpsj.fr

01·44·12·32·54

Facility Contacts

Camille GERLIER

Role: primary

cgerlier@ghpsj.fr

01·44·12·80·23

Other Identifiers

ID RCB : 2025-A02182-47

Identifier Type: OTHER

Identifier Source: secondary_id

782_RW-HOMECARE

Identifier Type: -

Identifier Source: org_study_id