an Acute PathologyTAKE CARENCT06449053
Preventing Iatrogenic Dependence Linked to Hospitalisation in Elderly Patients Hospitalised in Acute Geriatrics
A study testing ORGANIZATIONAL in people with an Acute Pathology, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Iatrogenic dependence linked to hospitalisation DILH is very frequent, severe but avoidable in 80% of cases. Extensive research has identified 6 main causes of DILH in the elderly, which interact and have common risk factors: immobilisation, falls, undernutrition, de novo urinary incontinence, confusion and drug… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- an Acute Pathology
- What is being tested?
- ORGANIZATIONAL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 918 participants
- Where
- 1 siteFrance
- Study dates
- 11 Feb 2025to 31 Dec 2026
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 75 ans
- Unscheduled hospitalisation in one of the participating departments for an acute pathology, excluding post-operative care
Who cannot join
- Patients with a usual ADL score (assessed 15 days before hospitalisation) of 0
- Stay > 72 hours in another facility before admission to UGA
- Opposition to participation in the study (trusted support person / guardian - curator)
- Not affiliated to a social security scheme (beneficiary or beneficiary entitled)
- Patient under AME
Trial locations and contacts
1 site in 1 country.
About this study
Iatrogenic dependence linked to hospitalisation DILH is very frequent, severe but avoidable in 80% of cases. Extensive research has identified 6 main causes of DILH in the elderly, which interact and have common risk factors: immobilisation, falls, undernutrition, de novo urinary incontinence, confusion and drug side-effects.
Our main hypothesis is that promoting access to, knowledge of and implementation of good practice recommendations by healthcare staff (medical and paramedical) concerning DILH in the elderly, based on graded interventions and targeting the 6 main causes of DILH, via the TAKE CARE intervention could reduce the incidence of DILH in the population of patients aged 75 or over hospitalised in acute geriatric units excluding post-operative and post-resuscitation, in the context of unscheduled hospitalizations.
Read more
A Multicenter, randomized, cluster trial evaluating the effect of the TAKE CARE intervention compared with usual care in patients will be conducted across 11 acute geriatric services in France. A total of 2200 patients will be needed for a total period of 6 months with a 6 months followup prior inclusion. Data will be collected directly from the patients' medical records and entered by an investigator or a clinical study technician in an electronic CRF (CleanWeb) managed by the URC PSL.
The trial will also include a qualitative component to assess, among other things, the implementation aspects of this complex intervention (individual interviews, focus group). A medico-economic component with a cost-utility analysis to assess the incremental cost-utility ratio, and a hospital microcosting study to assess the costs associated with the TAKE CARE intervention.
The impact of the TAKE CARE intervention will be studied using a "win-ratio" approach based on a hierarchical composite criterion that takes into account vital status at D7 and the change in ADL score between D15 before admission and D7. The difference in ADL score between D-15 and D7 will be compared between the 2 randomisation groups using a mixed linear model with the randomisation arm as a fixed effect and a random effect on the cluster. A win-ratio significantly greater than 1 will allow us to conclude that the TAKE CARE intervention is effective.
Read the detailed description
Hospitalization for an acute illness in older individuals is connected to a decline in functionality, referred to as iatrogenic dependence linked to hospitalization (DILH). This is characterized by the inability to perform essential daily activities necessary for independent living. The literature has identified six primary causes of DILH in the elderly, which interact and share common risk factors. These causes include immobilization, falls, undernutrition, de novo urinary incontinence, confusion, and drug side effects. DILH is a prevalent issue, affecting approximately 40% of elderly patients admitted to the hospital. However, it is important to note that 80% of these cases can be prevented with appropriate measures.
Our primary hypothesis revolves around the idea that by promoting access to, knowledge of, and implementation of best practice recommendations among healthcare staff (both medical and paramedical) regarding DILH in the elderly, we can effectively reduce the incidence of DILH in the population of patients aged 75 or over who are hospitalized in acute geriatric units (excluding post-operative and post-resuscitation cases) during unscheduled hospitalizations. This will be achieved through the implementation of the TAKE CARE intervention, which is a multifaceted organizational intervention designed to facilitate the adoption of all current recommendations for combating DILH in the elderly, utilizing innovative equipment such as portable and connected treadmills, installation of lighting with motion detectors in hospital room and use of the SYNAPSEMed application .
A randomized, cluster trial will be conducted across 11 acute geriatric services in France to evaluate the impact of the TAKE CARE intervention compared to usual care in patients. The trial will span over a period of 6 months, during which a total of 2200 patients will be included. Half of the patients (n=1,100) will be admitted to the 11 wings of the geriatric ward in the INTERVENTION arm, while the other half (n=1,100) will be assigned to the 11 wings in the control arm. Following the inclusion period, the patients will be followup for a period of 6 months. Demographic and clinical data will be collected from the patients' medical records and entered into an electronic CRF (CleanWeb) by either an investigator or a clinical study technician. The URC PSL will manage the CRF through the eTAKE-CARE® application, as well as the SynapseMed® application. Data management and statistical analysis will be conducted by the PSL-CFX URC, using either the statistical software R version 3.6.3 or later (R Foundation for Statistical Computing, Vienna, Austria, https://www.R-project.org/) or SAS (SAS Institute Inc., Cary, NC, USA).
The trial will also include a qualitative component to assess, among other things, the implementation aspects of this complex intervention (individual interviews, focus group). A medico-economic component with a cost-utility analysis to assess the incremental cost-utility ratio, and a hospital microcosting study to assess the costs associated with the TAKE CARE intervention. QALYs (quality of life) will be assessed using the EQ5D-3L scale, which is robust in the geriatric population. Two aspects will be taken into account when estimating the cost utility, one will be the costs attributable to the purchase and immobilisation of the equipment necessary for the implementation of the intervention, and on the other hand, the costs associated with operating this equipment in relation to patient care.
The effectiveness of the TAKE CARE intervention will be examined through the utilization of a "win-ratio" method, which employs a hierarchical composite criterion. This criterion considers the vital status at D7 and the change in ADL score between D15 prior to admission and D7. By comparing the difference in ADL score between D-15 and D7 in the two randomization groups using a mixed linear model, with the randomization arm as a fixed effect and a random effect on the cluster. A win-ratio significantly greater than 1 will allow us to conclude that the TAKE CARE intervention is effective.
- Conditions
- an Acute Pathology
- Being tested
- ORGANIZATIONAL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORGANIZATIONALProcedure or surgery
- a formalization of the recommendations to be applied to prevent DILH B. implemented and facilitated by an e-health application C. and will be based on adapting the hospital environment (connected mats, movement sensors, prescription assistance) D. and the dissemination of knowledge (production of summary and empowerment documents).
| Study group | Role | What they receive |
|---|---|---|
| TAKE CARE | Experimental | * Use of a dedicated e-health application. In order to promote the implementation of DILH prevention measures, we will use an e-health application developed specifically for the study by PRESAGE in the areas where the intervention will take place. This innovative application will be used on admission for all patients included in the acute geriatric sectors in which the intervention will be deployed. It will first assess the risk of DILH individually for each of the 6 risk factors, and then scale the risk for the patient. Once the risk assessment has been carried out, the system will immediately produce a document setting out the personalized care plan for each patient, and disseminate knowledge through documents aimed at patients and caregivers.
* The use of portable, connected treadmills (Ezygain, CE marked)
* The installation of motion detector lighting in hospital rooms Receives: Procedure: ORGANIZATIONAL |
| CURRENT CARE | No intervention | soins usuels |
What is being measured
The primary outcome is the main question the study is designed to answer.
DILH will be assessed by the difference in ADL score between the pre-admission state and the ADL score at D7
DILH will be assessed by the difference in the ADL score (Activities of Daily Living Independence Scale) between the pre-admission state (assessment on admission of the ADL score under usual living conditions corresponding to the ADL score 15 days before hospitalisation, as it is usually measured in the acute geriatric ward), and the ADL score on Day 7 (7th day of hospitalisation).
Measured: Through study time period, an average of 16 months
Secondary outcomes (2)
The change in ADL score between pre-admission status and J 7, as well as the change in ADL score between pre-admission status and hospital discharge, between admission and J 7, between pre-admission status and M3 and M6
The change in ADL score between pre-admission status and J 7
Measured: Through study time period, an average of 16 months
DILH will also be assessed by a new autonomy score currently under development to measure the effect of the intervention on each of the risk factors
DILH will also be assessed by a new autonomy score currently
Measured: Through study time period, an average of 16 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start11 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for an Acute PathologyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Use of a dedicated e-health application. In order to promote the implementation of DILH prevention measures, we will use an e-health application developed specifically for the study by PRESAGE in the areas where the intervention will take place. This innovative application will be used on admission for all patients included in the acute geriatric sectors in which the intervention will be deployed. It will first assess the risk of DILH individually for each of the 6 risk factors, and then scale the risk for the patient. Once the risk assessment has been carried out, the system will immediately produce a document setting out the personalized care plan for each patient, and disseminate knowledge through documents aimed at patients and caregivers. * The use of portable, connected treadmills (Ezygain, CE marked) * The installation of motion detector lighting in hospital rooms
- Masking
- None (open label)
- Enrolment
- 918 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449053
- Sponsor's protocol ID
- APHP (URCPSL)
- Acronym
- TAKE CARE
- Status last verified
- Jul 2026
- First submitted
- 23 May 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Iatrogenic Dependence Linked to Hospitalisation in Elderly Patients Hospitalised in Acute Geriatrics
- ClinicalTrials.gov ID
- NCT06449053
- Acronym / sponsor ID
- TAKE CARE / APHP (URCPSL)
- Conditions
- an Acute Pathology
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 918 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Jun 2024 (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.
Iatrogenic dependence linked to hospitalisation DILH is very frequent, severe but avoidable in 80% of cases. Extensive research has identified 6 main causes of DILH in the elderly, which interact and have common risk factors: immobilisation, falls, undernutrition, de novo urinary incontinence, confusion and drug side-effects.
Our main hypothesis is that promoting access to, knowledge of and implementation of good practice recommendations by healthcare staff (medical and paramedical) concerning DILH in the elderly, based on graded interventions and targeting the 6 main causes of DILH, via the TAKE CARE intervention could reduce the incidence of DILH in the population of patients aged 75 or over hospitalised in acute geriatric units excluding post-operative and post-resuscitation, in the context of unscheduled hospitalizations.
A Multicenter, randomized, cluster trial evaluating the effect of the TAKE CARE intervention compared with usual care in patients will be conducted across 11 acute geriatric services in France. A total of 2200 patients will be needed for a total period of 6 months with a 6 months followup prior inclusion. Data will be collected directly from the patients' medical records and entered by an investigator or a clinical study technician in an electronic CRF (CleanWeb) managed by the URC PSL.
The trial will also include a qualitative component to assess, among other things, the implementation aspects of this complex intervention (individual interviews, focus group). A medico-economic component with a cost-utility analysis to assess the incremental cost-utility ratio, and a hospital microcosting study to assess the costs associated with the TAKE CARE intervention.
The impact of the TAKE CARE intervention will be studied using a "win-ratio" approach based on a hierarchical composite criterion that takes into account vital status at D7 and the change in ADL score between D15 before admission and D7. The difference in ADL score between D-15 and D7 will be compared between the 2 randomisation groups using a mixed linear model with the randomisation arm as a fixed effect and a random effect on the cluster. A win-ratio significantly greater than 1 will allow us to conclude that the TAKE CARE intervention is effective.
Detailed description
Hospitalization for an acute illness in older individuals is connected to a decline in functionality, referred to as iatrogenic dependence linked to hospitalization (DILH). This is characterized by the inability to perform essential daily activities necessary for independent living. The literature has identified six primary causes of DILH in the elderly, which interact and share common risk factors. These causes include immobilization, falls, undernutrition, de novo urinary incontinence, confusion, and drug side effects. DILH is a prevalent issue, affecting approximately 40% of elderly patients admitted to the hospital. However, it is important to note that 80% of these cases can be prevented with appropriate measures.
Our primary hypothesis revolves around the idea that by promoting access to, knowledge of, and implementation of best practice recommendations among healthcare staff (both medical and paramedical) regarding DILH in the elderly, we can effectively reduce the incidence of DILH in the population of patients aged 75 or over who are hospitalized in acute geriatric units (excluding post-operative and post-resuscitation cases) during unscheduled hospitalizations. This will be achieved through the implementation of the TAKE CARE intervention, which is a multifaceted organizational intervention designed to facilitate the adoption of all current recommendations for combating DILH in the elderly, utilizing innovative equipment such as portable and connected treadmills, installation of lighting with motion detectors in hospital room and use of the SYNAPSEMed application .
A randomized, cluster trial will be conducted across 11 acute geriatric services in France to evaluate the impact of the TAKE CARE intervention compared to usual care in patients. The trial will span over a period of 6 months, during which a total of 2200 patients will be included. Half of the patients (n=1,100) will be admitted to the 11 wings of the geriatric ward in the INTERVENTION arm, while the other half (n=1,100) will be assigned to the 11 wings in the control arm. Following the inclusion period, the patients will be followup for a period of 6 months. Demographic and clinical data will be collected from the patients' medical records and entered into an electronic CRF (CleanWeb) by either an investigator or a clinical study technician. The URC PSL will manage the CRF through the eTAKE-CARE® application, as well as the SynapseMed® application. Data management and statistical analysis will be conducted by the PSL-CFX URC, using either the statistical software R version 3.6.3 or later (R Foundation for Statistical Computing, Vienna, Austria, https://www.R-project.org/) or SAS (SAS Institute Inc., Cary, NC, USA).
The trial will also include a qualitative component to assess, among other things, the implementation aspects of this complex intervention (individual interviews, focus group). A medico-economic component with a cost-utility analysis to assess the incremental cost-utility ratio, and a hospital microcosting study to assess the costs associated with the TAKE CARE intervention. QALYs (quality of life) will be assessed using the EQ5D-3L scale, which is robust in the geriatric population. Two aspects will be taken into account when estimating the cost utility, one will be the costs attributable to the purchase and immobilisation of the equipment necessary for the implementation of the intervention, and on the other hand, the costs associated with operating this equipment in relation to patient care.
The effectiveness of the TAKE CARE intervention will be examined through the utilization of a "win-ratio" method, which employs a hierarchical composite criterion. This criterion considers the vital status at D7 and the change in ADL score between D15 prior to admission and D7. By comparing the difference in ADL score between D-15 and D7 in the two randomization groups using a mixed linear model, with the randomization arm as a fixed effect and a random effect on the cluster. A win-ratio significantly greater than 1 will allow us to conclude that the TAKE CARE intervention is effective.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Use of a dedicated e-health application. In order to promote the implementation of DILH prevention measures, we will use an e-health application developed specifically for the study by PRESAGE in the areas where the intervention will take place. This innovative application will be used on admission for all patients included in the acute geriatric sectors in which the intervention will be deployed. It will first assess the risk of DILH individually for each of the 6 risk factors, and then scale the risk for the patient. Once the risk assessment has been carried out, the system will immediately produce a document setting out the personalized care plan for each patient, and disseminate knowledge through documents aimed at patients and caregivers. * The use of portable, connected treadmills (Ezygain, CE marked) * The installation of motion detector lighting in hospital rooms
| Arm | Type | Receives |
|---|---|---|
| TAKE CARE | Experimental | Procedure: ORGANIZATIONAL* Use of a dedicated e-health application. In order to promote the implementation of DILH prevention measures, we will use an e-health application developed specifically for the study by PRESAGE in the areas where the intervention will take place. This innovative application will be used on admission for all patients included in the acute geriatric sectors in which the intervention will be deployed. It will first assess the risk of DILH individually for each of the 6 risk factors, and then scale the risk for the patient. Once the risk assessment has been carried out, the system will immediately produce a document setting out the personalized care plan for each patient, and disseminate knowledge through documents aimed at patients and caregivers. * The use of portable, connected treadmills (Ezygain, CE marked) * The installation of motion detector lighting in hospital rooms |
| CURRENT CARE | No intervention | –soins usuels |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age ≥ 75 ans
- Unscheduled hospitalisation in one of the participating departments for an acute pathology, excluding post-operative care
Key exclusion criteria (5 listed)
- Patients with a usual ADL score (assessed 15 days before hospitalisation) of 0
- Stay > 72 hours in another facility before admission to UGA
- Opposition to participation in the study (trusted support person / guardian - curator)
- Not affiliated to a social security scheme (beneficiary or beneficiary entitled)
- Patient under AME
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 |
|---|---|---|
| ORGANIZATIONALA. a formalization of the recommendations to be applied to prevent DILH B. implemented and facilitated by an e-health application C. and will be based on adapting the hospital environment (connected mats, movement sensors, prescription assistance) D. and the dissemination of knowledge (production of summary and empowerment documents). | Procedure or surgery | TAKE CARE |
Primary outcome
DILH will be assessed by the difference in ADL score between the pre-admission state and the ADL score at D7
Time frame: Through study time period, an average of 16 months
DILH will be assessed by the difference in the ADL score (Activities of Daily Living Independence Scale) between the pre-admission state (assessment on admission of the ADL score under usual living conditions corresponding to the ADL score 15 days before hospitalisation, as it is usually measured in the acute geriatric ward), and the ADL score on Day 7 (7th day of hospitalisation).
2 secondary outcomes
The change in ADL score between pre-admission status and J 7, as well as the change in ADL score between pre-admission status and hospital discharge, between admission and J 7, between pre-admission status and M3 and M6
Time frame: Through study time period, an average of 16 months
DILH will also be assessed by a new autonomy score currently under development to measure the effect of the intervention on each of the risk factors
Time frame: Through study time period, an average of 16 monthes
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 13 Jul 2026.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ORGANIZATIONAL in people with an Acute Pathology, run by Assistance Publique - Hôpitaux de Paris 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 2 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DILH will be assessed by the difference in ADL score between the pre-admission state and the ADL score at D7 (time frame: Through study time period, an average of 16 months). 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 13 Jul 2026.