NCT07348081|Recruiting
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
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RW-HOMECARE
Sponsor study identifier
Secondary identifiers
OTHER · ANSM
interventional
100
1 country
1
Study Start
December 12, 2025
Actual (reported)Primary Completion
March 12, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 12, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 12, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 11, 2025
Actual (reported)December 12, 2025
Actual (reported)January 16, 2026
Actual (reported)March 12, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 12, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
Testing of the MyMonka solution; Response to questionnaires during the follow-up period on quality of life and burden measurement
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hôpital Paris Saint-Joseph
Paris, 75014, France
First Submitted
December 11, 2025
First Posted
January 16, 2026
Study Start
December 12, 2025
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
March 12, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 12, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 16, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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