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.

NCT07348081 | Recruiting

• 2 other identifiers: 782_RW-HOMECAREID RCB : 2025-A02182-47
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Frailty syndrome; Non-professional caregiver; Burden

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

Caregivers supporting vulnerable patients and using the MyMonka solution. OTHER

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead
• Monka Care: collaborator

Study Sites (1)

Hôpital Paris Saint-Joseph

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Camilla GERLIER, Doctor

CONTACT

01·44·12·80·23; cgerlier@ghpsj.fr

Célia MAMMA

CONTACT

01·44·12·32·54; cmamma@ghpsj.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, longitudinal, single-center pilot study designed to evaluate the effects of the proposed use of the Monka digital solution in real-world conditions and in accordance with the principles of VBHC (Value-Based Health Care), a systemic approach aimed at maximizing the value of care for patients, defined as the ratio between the clinical results obtained and the resources mobilized to achieve them.

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 16, 2026
• Study Start: December 12, 2025
• Primary Completion (Estimated): March 12, 2027
• Study Completion (Estimated): March 12, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

FR (1)