Patients Beneficiting of Temporary HebergementHT77NCT04014049
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
An observational study of Patients Beneficiting of Temporary Hebergement, run by Gérond'if at 1 site in France.
Trial summary
The main objective is to study the impact of Temporary Hebergement (TH), as a medico-social care link between hospital and home, on the length of hospitalization in the referral services. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Patients Beneficiting of Temporary Hebergement
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2020to 30 Jul 2021
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving funded beds for "temporary accommodation" within EHPAD (Retirement Hom) recruiters.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Geriatric department , Broca Hospital
Paris, Île-de-France Region, 75013
About this study
The main objective is to study the impact of Temporary Hebergement (TH), as a medico-social care link between hospital and home, on the length of hospitalization in the referral services.
Read the 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
- Keywords
- Temporary Hebergement (TH), Retirement Home (EHPAD), Discharge at home
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180 days
Secondary outcomes (7)
Assessment of commorbidity risk according Charlson score
Measured: Inclusion , 2days
Assessment of teh degree of autonomy according AGGIR score
Measured: 180 days
Assessment of quality of life according "Nottingham health profile" scale
Measured: 180 days
Assessment of health-related quality of life according SF-36 (Medical outcome study Short-Form health survey-36 items)
Measured: 180 days
Assessment of the emotional, physical and financial burden on a caregiver according Zarit burden scale
Measured: 180 days
Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
Measured: 180 days
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start17 Jan 2020
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Why it stopped: This study had to halt due to covid 19 pandemy.In fact, during the pandemy the two instutitions whose were included in this study were no longer accessible so this trial couldn't resume.In addition, the main criteria was invalidated by the pandemy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Beneficiting of Temporary HebergementStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Hanon, MD PhD, Study chair, Geriatric Departement, Broca hospital, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014049
- Sponsor's protocol ID
- 2019-A01189-48
- Acronym
- HT77
- Status last verified
- Feb 2023
- First submitted
- 7 Jul 2019
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04014049
- Acronym / sponsor ID
- HT77 / 2019-A01189-48
- Keywords
- Temporary Hebergement (TH), Retirement Home (EHPAD), Discharge at home
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study had to halt due to covid 19 pandemy.In fact, during the pandemy the two instutitions whose were included in this study were no longer accessible so this trial couldn't resume.In addition, the main criteria was invalidated by the pandemy.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 10 Jul 2019 (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 is to study the impact of Temporary Hebergement (TH), as a medico-social care link between hospital and home, on the length of hospitalization in the referral services.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving funded beds for "temporary accommodation" within EHPAD (Retirement Hom) recruiters.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
Assessment of commorbidity risk according Charlson score
Time frame: Inclusion , 2days
Assessment of teh degree of autonomy according AGGIR score
Time frame: 180 days
Assessment of quality of life according "Nottingham health profile" scale
Time frame: 180 days
Assessment of health-related quality of life according SF-36 (Medical outcome study Short-Form health survey-36 items)
Time frame: 180 days
Assessment of the emotional, physical and financial burden on a caregiver according Zarit burden scale
Time frame: 180 days
Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
Time frame: 180 days
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Time frame: 180 days
Results and safety
The study was stopped early (reason given: This study had to halt due to covid 19 pandemy.In fact, during the pandemy the two instutitions whose were included in this study were no longer accessible so this trial couldn't resume.In addition, the main criteria was invalidated by the pandemy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
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.
Olivier Hanon, MD PhD study chair
Geriatric Departement, Broca hospital, Paris
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 Patients Beneficiting of Temporary Hebergement, 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 6 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: stopped early, as of the sponsor's last update on 6 Feb 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?
The study was stopped early (reason given: This study had to halt due to covid 19 pandemy.In fact, during the pandemy the two instutitions whose were included in this study were no longer accessible so this trial couldn't resume.In addition, the main criteria was invalidated by the pandemy.). Results are not available in the source record.
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?
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). 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 6 Feb 2023.