Frailty SyndromeRW-HOMECARENCT07348081
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.
A study testing Caregivers supporting vulnerable patients and using the MyMonka solution. in people with Frailty Syndrome and Caregiver Burden for Those Who Care for Adults With Impaired Functional Status, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frailty Syndrome, Caregiver Burden for Those Who Care for Adults With Impaired Functional Status
- What is being tested?
- Caregivers supporting vulnerable patients and using the MyMonka solution.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2025to 12 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Paris Saint-Joseph
Paris, 75014
Camille GERLIER, 01·44·12·80·23, cgerlier@ghpsj.fr
About this study
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
- Being tested
- Caregivers supporting vulnerable patients and using the MyMonka solution.
- Keywords
- Frailty syndrome, Non-professional caregiver, Burden
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Patient and caregiver dyad experiencing the MyMonka solution in real-life conditions | Experimental | Not described Receives: Other: Caregivers supporting vulnerable patients and using the MyMonka solution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days 0 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start12 Dec 2025
- Primary completion12 Mar 2027 (estimated)
- Study completion12 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Collaborators
- Monka Care
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348081
- Sponsor's protocol ID
- 782_RW-HOMECARE
- Other IDs
- ID RCB : 2025-A02182-47
- Acronym
- RW-HOMECARE
- Status last verified
- Jan 2026
- First submitted
- 11 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07348081
- Acronym / sponsor ID
- RW-HOMECARE / 782_RW-HOMECARE
- Conditions
- Frailty Syndrome, Caregiver Burden for Those Who Care for Adults With Impaired Functional Status
- Keywords
- Frailty syndrome, Non-professional caregiver, Burden
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Collaborators
- Monka Care
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 12 Mar 2027 (estimated)
- Study completion
- 12 Mar 2027 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patient and caregiver dyad experiencing the MyMonka solution in real-life conditions | Experimental | Other: Caregivers supporting vulnerable patients and using the MyMonka solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Patient and caregiver dyad experiencing the MyMonka solution in real-life conditions |
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregivers supporting vulnerable patients and using the MyMonka solution. in people with Frailty Syndrome and Caregiver Burden for Those Who Care for Adults With Impaired Functional Status, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camilla GERLIER, Doctor (01·44·12·80·23, cgerlier@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.