Real World Evidence to Assess the Value of a Digital Care... | NCT07348081

Studies
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

Sponsor

Fondation Hôpital Saint-Joseph

Status

Recruiting

Last Update Posted

Jan 16, 2026Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

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

Interventions

Caregivers supporting vulnerable patients and using the MyMonka solution.

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
ID RCB : 2025-A02182-47	Other Identifier	ANSM

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2025Actual

Primary Completion Date

Mar 12, 2027Estimated

Completion Date

Mar 12, 2027Estimated

First Submitted Date

Dec 11, 2025

First Submission Date that Met QC Criteria

Jan 9, 2026

First Posted Date

Jan 16, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2026

Last Update Posted Date

Jan 16, 2026Actual

Name	Class
Monka Care	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient and caregiver dyad experiencing the MyMonka solution in real-life conditions	Experimental		Other: Caregivers supporting vulnerable patients and using the MyMonka solution.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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.

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Camilla GERLIER, Doctor	Contact	01·44·12·80·23		cgerlier@ghpsj.fr
Célia MAMMA	Contact	01·44·12·32·54		cmamma@ghpsj.fr

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Paris Saint-Joseph	Recruiting	Paris		75014	France

Intervention Model Description

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.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms