- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06098534
Evaluation of a Prototype for an Innovative Room for the Elderly (HOSPISENIOR)
Evaluation d'un Prototype de Chambre Innovante adaptée au Grand Age
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The main objective is to evaluate the effect of hospitalization in a Hospi'Senior room on the length of stay of elderly people compared with hospitalization in a conventional room for a similar admission reason.
The secondary objectives are to evaluate the effect of hospitalization in a Hospi'Senior room for elderly people, compared with hospitalization in a conventional room for a similar admission reason, on :
2) Changes in functional abilities during the hospital stay and in the 30 days following discharge from the short-stay geriatric unit 3) Occurrence of behavioral disorders 4) Occurrence of falls during the hospital stay and in the 30 days following discharge from the short-stay geriatric unit 5) Occurrence and/or worsening of stage bedsores ≥ 2 during the hospital stay as classified by the National Pressure Ulcer Advisory Panel (NPUAP) 6) Occurrence of early rehospitalization
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Olivier BRIERE, MD
- Phone Number: +33 2 41 35 47 25
- Email: olivier.briere@chu-angers.fr
Study Locations
-
-
-
Angers, France, 49933
- Recruiting
- Angers University Hospital
-
Contact:
- Cédric ANNWEILER, MD, PhD
-
Brest, France, 29200
- Recruiting
- Brest University Hospital
-
Contact:
- Armelle GENTRIC, MD, PhD
-
Nantes, France, 44093
- Recruiting
- Nantes University Hospital
-
Contact:
- Guillaume CHAPELET, MD
-
Rennes, France, 35033
- Recruiting
- Rennes University Hospital
-
Contact:
- Aline CORVOL, MD
-
Tours, France, 37044
- Recruiting
- Tours University Hospital
-
Contact:
- Wassim GANA, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 75 years
- Admission in a short-stay geriatric department following initial emergency care department or direct entry from home
- Hospitalization in single room: Hospi'Senior or conventional
- Affiliation to a social security scheme
- Informed consent to participate in the study from the patient or his/her representative (tutor/curator if applicable, or in order of priority a trusted person, the family or a person with whom the person concerned has a close and stable relationship)
Exclusion Criteria:
- Contraindication to study participation at the discretion of the medical team
- Hospitalization for more than 3 days (>3 days) in the short-stay geriatric unit
- Hospitalization in a double room
- Planned hospitalization
- Poor understanding of the French language
- Patient under safeguard of justice
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: "Hospi'Senior" group
Patients admitted to the Hospi'Senior room benefit from the innovative technologies available in this room.
Patients benefit from standard care throughout their hospital stay.
|
The Hospi'Senior room is equipped with conventional furnishings (same bed and same armchair as a conventional room) to which have been added technological innovations and innovations in furnishings.
Innovative technologies cover bed equipment, patient mobility (autonomous and assisted), lighting, communication and social space.
|
|
Experimental: "Conventional room" group
Patients admitted to a conventional room receive the standard care throughout their hospital stay.
|
The conventional room is a classic hospital room not equipped with the innovative technologies found in the Hospi'Senior room. The room is equipped with a bed, bedside table, adjustable bed table with castors and an armchair. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of stay in the short-stay geriatric unit
Time Frame: This outcome is assessed at the end of the geriatric unit stay (up to 2 months)
|
The length of stay is measured in days
|
This outcome is assessed at the end of the geriatric unit stay (up to 2 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in functional capabilities
Time Frame: This outcome is assessed at inclusion, on discharge (up to 2 months) and within 30 days of discharge from the short-stay geriatric unit
|
Functional capabilities are assessed with Activities of Daily Living (ADL) score. ADL is an autonomy assessment grid (from 0 to 6) for basic activities of daily living. The lower the score, the more dependent the patient is. |
This outcome is assessed at inclusion, on discharge (up to 2 months) and within 30 days of discharge from the short-stay geriatric unit
|
|
Occurrence of behavioral disorders
Time Frame: This outcome is assessed at inclusion and on discharge (up to 2 months)
|
Behavioral disorders are assessed with Neuropsychiatric Inventory-nursing home version (NPI-NH) score. For each scale domain, higher scores indicate greater neuropsychiatric symptomatology (range from 0 to 12/12). |
This outcome is assessed at inclusion and on discharge (up to 2 months)
|
|
Occurrence of falls
Time Frame: This outcome is assessed on discharge (up to 2 months) and within 30 days of discharge from the short-stay geriatric unit
|
Number of falls observed during hospital stay and within 30 days of discharge from the short-stay geriatric unit
|
This outcome is assessed on discharge (up to 2 months) and within 30 days of discharge from the short-stay geriatric unit
|
|
Occurrence and/or worsening of stage bedsores ≥ 2
Time Frame: This outcome is assessed on discharge (up to 2 months)
|
Occurrence and/or worsening of stage bedsores ≥ 2 during hospital stay
|
This outcome is assessed on discharge (up to 2 months)
|
|
Occurrence of early rehospitalization
Time Frame: This outcome is assessed within 30 days of discharge from the short-stay geriatric unit
|
Number of unscheduled hospitalization in a Medicine-Surgery-Obstetrics (MSO) unit within 30 days of discharge from the short-stay geriatric unit
|
This outcome is assessed within 30 days of discharge from the short-stay geriatric unit
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Other Study ID Numbers
- 49RC23_0276
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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