- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04014049
Assessment of the Relevance of a Medico-social Care of Elderly Patients, in Relay Between Hospital and Home: Experimentation of TEMPORARY HERBERGEMENT in Retirement Home " EHPAD " in Seine-et-Marne Department (HT77)
Study Overview
Status
Detailed Description
It's a non-interventional, multi-centre study.
The request for Temporary Hebergement must be made by the principal investigator or on the recommendation of the other doctors in the co-investigator department at least 48 hours before the discharge from hospital. The EHPAD (Retirement Home) coordinating physician and/or nurse coordinator and the social worker plan the hospitalization release for Temporary Accommodation admission. The social worker must validate with the doctors the feasibility and coherence of the project of return to home, and write a summary attached to the admission file (social report) which will be used in the final analysis of the patients' return-to-home projects included in the study.
The hospital discharge for admission to HT is made with the agreement of the hospital doctor and the host EHPAD (Retirement home). A "check-list" is established to complete the patient's chart.
Upon admission and management of the patient in Temporary Hebergement , he will be followed by his treating physician. If necessary, the on-call doctor of the department that referred the patient may be contacted in case of hospital-applicant care. A mid-term review will be planned by the EHPAD (Retirement home social) worker to anticipate situations at risk of exit blockage at Day 30. The patient will be able to benefit from physiotherapy and speech therapy on prescription by liberal professionals working in the EHPAD, as well as occupational therapy and psychomotricity on the prescription of the coordinating physician during the development of the accompanying project. In addition, the Temporary Hebergement beneficiary will be able to participate in all the social activities of the residence, according to his wishes.
The following data: Quality of Life Questionnaire for Patients (Nottingham Scale) and Caregivers (SF-36 Scale), Caregiver Helper Questionnaire for Home Patients, Caregiver Burden Scale (Zarit) , ADL and IADL scales, EHPAD Patient and Caregiver Perception Questionnaire, Study Acceptability Questionnaire for Included Topics, Patient Comorbidity Evaluation Scale (Charlson) and Socio-Dataeconomic) are collected retrospectively, at Day 0 (inclusion), at Day 15, Day 30, Day 90 and Day 180 which corresponds to the end of the follow-up of patients provided for in the protocol
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ile-de-France
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Paris, Ile-de-France, France, 75013
- Geriatric department , Broca Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient verbally expressing his non-opposition to participation in the study and documented in the medical record by the physician
- Hospitalized in hospitals selected as recruiting centers
- Whose condition is considered compatible by the clinician with discharge from the hospital (stabilized clinical condition)
- Resident, before hospitalization, in the department of Seine-et-Marne
- Presenting a defined and feasible return home project
- whose social situation does not allow an immediate return to the home on discharge from hospital
Exclusion Criteria:
- Patient expressing his opposition to participation in the study
- Acute condition not stabilized as per physician's medical opinion
- Requiring non-insured care by the host EHPAD, namely intravenous infusions, peritoneal dialysis, palliative care, etc.
- MMS score below 18
- Exhibiting behavioural disorders with major aggression and walking
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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The main criterion used is the average length of stay (DMS) found at the end of the study, compared to the MSD for the two previous years in the services addressed.
Time Frame: 180 days
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180 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Assessment of commorbidity risk according Charlson score
Time Frame: Inclusion , 2days
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Inclusion , 2days
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Assessment of teh degree of autonomy according AGGIR score
Time Frame: 180 days
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180 days
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Assessment of quality of life according "Nottingham health profile" scale
Time Frame: 180 days
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180 days
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Assessment of health-related quality of life according SF-36 (Medical outcome study Short-Form health survey-36 items)
Time Frame: 180 days
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180 days
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Assessment of the emotional, physical and financial burden on a caregiver according Zarit burden scale
Time Frame: 180 days
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180 days
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Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
Time Frame: 180 days
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180 days
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Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Time Frame: 180 days
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180 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2019-A01189-48
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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