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NCT Number: 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.

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.

Recruiting

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Key information

Conditions

Frailty Syndrome Caregiver Burden for Those Who Care for Adults With Impaired Functional Status Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Paris Saint-Joseph

Paris, 75014, France

Location status: Recruiting

Location contact

Camille GERLIER

CONTACT

[email protected]

01·44·12·80·23

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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.

    Time frame: Days 0, 30 and 90

Secondary outcomes

  1. 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.

    Time frame: Days 30 and 90

  2. Change in patient frailty expressed as the difference between the Clinical Frailty Scale score obtained at inclusion and on day 90.

    Time frame: Days 0 and 90

  3. 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.

    Time frame: Days 90

  4. 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.

    Time frame: Days 0 and 90

Study contacts

Contact information is provided by the study sponsor or research team.

Camilla GERLIER, Doctor

CONTACT

[email protected]

01·44·12·80·23

Célia MAMMA

CONTACT

[email protected]

01·44·12·32·54

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Collaborators

  • Monka Care

Registry information

Acronym: RW-HOMECARE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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