Caregiver-patient DyedsETAP-UNCT05561101
Evolution of the Health Status of Caregivers After the Admission of Their Elderly Relative to the Emergency Department
An observational study of Caregiver-patient Dyeds and Patient Without Cognitive Disorders, run by Gérond'if at 1 site in France.
Trial summary
The main objective of this non-interventional, propective and multipercentric study is to Assess the evolution of caregiver burden 1 month after their elderly relative's Emergency Department (ED) admission Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver-patient Dyeds, Patient Without Cognitive Disorders
- What is being tested?
- Caregivers burden
- How many people
- 125 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2022to 20 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Older adult
Study population: Patients - caregivers dyads aged 75 years and over, after admission to the elderly Emergency Department, without indication for hospitalization and living at home outside Nursing Home (EHPAD)
Who may be able to join
- Adult caregivers - patients aged 75 and over dyads consulting in Emergency Department and living at home
- Patients admitted to the emergency department for less than 48 hours for which a return home is decided
- Non-verbal opposition of the patient and caregiver to the collection of their data.
Who cannot join
- Hospitalized patient after emergency
- Patient admitted to emergency for life-saving emergency
- Patient living Nursing Home (EHPAD)
- Language barrier
- Absence of identified caregivers
- Severe cognitive impairment as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria and absence relative at time of inclusion
- Patients under guardianship
- Oral opposition from the patient and caregiver to their data collection.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Emergency Department, Bichat Hospital
Paris, Île-de-France Region, 75018
PATRY Claire, MD, +33(0)153111818, claire.patry@aphp.fr
About this study
The main objective of this non-interventional, propective and multipercentric study is to Assess the evolution of caregiver burden 1 month after their elderly relative's Emergency Department (ED) admission
Read the detailed description
The aim purpose of this non-interventional, prospertive study is to compare the evolution of caregiver burden between inclusion and 1month after their elderly relative's ED admission.
Inclusion of caregivers - patients dyads, meeting inclusion criteria and agreeing to participate, is carried out by geriatric mobile teams (EMG) working within Emergengy Department.
At inclusion the following data will be collected:
For the patient :
- Presence of neurocognitive disorders
- Sociodemographic data (age, gender, lifestyle)
- Patient comorbidities
- Autonomy and independence
- Risk of early readmission and loss of autonomy
For the caregiver:
- Socio-demographic data
- The caregiver's burden
- Quality of life
- Resilience capacity will be measured
The follow-up of the caregiver is carried out 1 month after the passage of his elderly relative to Emergency Department (at inclusion). The levels of burden and quality of life as well as the aids set up at home will be collected
- Being tested
- Caregivers burden
- Keywords
- Caregiver-patient dyeds, Emergency Department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregivers burdenOther
Assessment of caregiver burden after admision at Emergency Department of their elderly relative
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of caregiver burden by the 7-item Zarit burden scale (Mini-zarit)
Measured: 1 month
Secondary outcomes (8)
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Measured: At inclusion
Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
Measured: At inclusion
Assessment of complications risks according Triage Risk Screening Tool score (TRST)
Measured: At inclusion
Assessment of cognitive state of elderly patients according Abbreviated Mental Test 4 score (AMT-4)
If score < 4 must search for neurocognitive disorders
Measured: At inclusion
Assessment of commorbidity risk according Charlson score
Measured: At inclusion
Assessment of quality of life of cargivers according SF-12 score
Measured: 1 month
Measure of caregiver satisfaction according Likert scale
Measured: 1 month
Measure of resilience capacities acoording Brief Resilience Scale (BRS)
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start20 Sep 2022
- Primary completion20 Mar 2024 (estimated)
- Study completion20 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver-patient DyedsStudies 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
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PATRY Claire, MD, Study chair, Extern Geriatric Mobile Team
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561101
- Sponsor's protocol ID
- 2022-A01294-39
- Acronym
- ETAP-U
- Status last verified
- Feb 2023
- First submitted
- 27 Sep 2022
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of the Health Status of Caregivers After the Admission of Their Elderly Relative to the Emergency Department
- ClinicalTrials.gov ID
- NCT05561101
- Acronym / sponsor ID
- ETAP-U / 2022-A01294-39
- Keywords
- Caregiver-patient dyeds, Emergency Department
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 20 Mar 2024 (estimated)
- Study completion
- 20 Apr 2024 (estimated)
- First posted
- 30 Sep 2022 (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 main objective of this non-interventional, propective and multipercentric study is to Assess the evolution of caregiver burden 1 month after their elderly relative's Emergency Department (ED) admission
Detailed description
The aim purpose of this non-interventional, prospertive study is to compare the evolution of caregiver burden between inclusion and 1month after their elderly relative's ED admission.
Inclusion of caregivers - patients dyads, meeting inclusion criteria and agreeing to participate, is carried out by geriatric mobile teams (EMG) working within Emergengy Department.
At inclusion the following data will be collected:
For the patient :
- Presence of neurocognitive disorders
- Sociodemographic data (age, gender, lifestyle)
- Patient comorbidities
- Autonomy and independence
- Risk of early readmission and loss of autonomy
For the caregiver:
- Socio-demographic data
- The caregiver's burden
- Quality of life
- Resilience capacity will be measured
The follow-up of the caregiver is carried out 1 month after the passage of his elderly relative to Emergency Department (at inclusion). The levels of burden and quality of life as well as the aids set up at home will be collected
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients - caregivers dyads aged 75 years and over, after admission to the elderly Emergency Department, without indication for hospitalization and living at home outside Nursing Home (EHPAD)
Key inclusion criteria (3 listed)
- Adult caregivers - patients aged 75 and over dyads consulting in Emergency Department and living at home
- Patients admitted to the emergency department for less than 48 hours for which a return home is decided
- Non-verbal opposition of the patient and caregiver to the collection of their data.
Key exclusion criteria (8 listed)
- Hospitalized patient after emergency
- Patient admitted to emergency for life-saving emergency
- Patient living Nursing Home (EHPAD)
- Language barrier
- Absence of identified caregivers
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 burdenAssessment of caregiver burden after admision at Emergency Department of their elderly relative | Other | – |
Primary outcome
Measure of caregiver burden by the 7-item Zarit burden scale (Mini-zarit)
Time frame: 1 month
8 secondary outcomes
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Time frame: At inclusion
Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
Time frame: At inclusion
Assessment of complications risks according Triage Risk Screening Tool score (TRST)
Time frame: At inclusion
Assessment of cognitive state of elderly patients according Abbreviated Mental Test 4 score (AMT-4)
Time frame: At inclusion
Assessment of commorbidity risk according Charlson score
Time frame: At inclusion
Assessment of quality of life of cargivers according SF-12 score
Time frame: 1 month
Measure of caregiver satisfaction according Likert scale
Time frame: 1 month
Measure of resilience capacities acoording Brief Resilience Scale (BRS)
Time frame: At inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: No
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.
PATRY Claire, MD study chair
Extern Geriatric Mobile Team
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caregiver-patient Dyeds and Patient Without Cognitive Disorders, run by Gérond'if 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 3 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: status not confirmed, as of the sponsor's last update on 1 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DUFOUR Isabelle (+33 (0) 185781010, isabelle.dufour@gerondif.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of caregiver burden by the 7-item Zarit burden scale (Mini-zarit) (time frame: 1 month). 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 1 Mar 2023.