Design of a Prototype Garment Adapted to Demented Elderly Subjects With Disturbing Behavioral Problems in the Management of Sphincter Disorders (GERONESIE)
Primary Purpose
Adapted Garment Prototype, Elderly, Problem Behavior
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
garment
Sponsored by
About this trial
This is an interventional supportive care trial for Adapted Garment Prototype focused on measuring adapted garment prototype, patient dignity, elderly, behavioral troubles, Dementia, sphincter disorders
Eligibility Criteria
Inclusion Criteria: Patients hospitalized in a cognitive-behavioral unit or long-term care or residents of the EHPAD at the St-Victor center - CHU Amiens-Picardie, patients with behavioral and sphincter disorders justifying the prescription of a romper. signature of a consent exclusion criteria Exclusion Criteria: No next of kin Patients in terminal palliative care Patients whose morphology does not allow the use of prototypes (no adapted size)
Sites / Locations
- Centre Hospitalier Universitaire d'Amiens
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
conventional garment
prototype garment
Arm Description
Outcomes
Primary Outcome Measures
variation of satisfaction score between both groups of patients
Satisfaction score will be measured with an home-made questionary. Higher scores for highest satisfactory. the questionary is composed of 10 questions.
Secondary Outcome Measures
Full Information
NCT ID
NCT05649839
First Posted
December 6, 2022
Last Updated
January 17, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT05649839
Brief Title
Design of a Prototype Garment Adapted to Demented Elderly Subjects With Disturbing Behavioral Problems in the Management of Sphincter Disorders
Acronym
GERONESIE
Official Title
Design of a Prototype Garment Adapted to Demented Elderly Subjects With Disturbing Behavioral Problems in the Management of Sphincter Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 6, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
January 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Alzheimer's disease and related disorders (ADRD) are diseases whose frequency is increasing in elderly subjects. Their evolution is marked by the occurrence, in addition to cognitive disorders, of increasingly disruptive behavioral disorders that interfere with their management, as well as impairment of basic functions, including the occurrence of sphincter disorders responsible for daytime and nighttime urinary and fecal incontinence. These disorders are present in more than 80% of LAM patients and are of multifactorial origin.
It is difficult to get patients to accept wearing the necessary protection. They tend to remove or tear them off. This can frequently lead to stressful situations of agitation and inappropriate behavior for patients and uncomfortable continence management for caregivers.
In order not to be forced to use heavy physical restraints or therapeutics that promote drowsiness so that the patient cannot remove his or her protections, the only effective response today is to wear a garment. Unfortunately, the ones that exist today are strictly functional and are worn at night.
The use of such garments, during the day, in this indication, is therefore a common and usual practice today.
This results in an ethical problem for the caregivers. Indeed, worn during the day, rompers give the impression to the latter that they show a devaluing, infantilizing or even degrading image of the elderly person. This practice, although common and accepted because it is the only recourse to physical and chemical restraints to preserve the cleanliness and presentation of elderly patients, could lead to an impaired dignity which could be badly experienced by their close circle of friends and family as well as by the carers and could also have an impact on the overall effectiveness of the care .
This is the first time that a multi-professional team integrating doctors, caregivers, occupational therapists and engineers have reflected on the design of a garment that meets the expectations of caregivers, patients and their families. The romper thus designed must be able to retain the aesthetic characteristics of a garment that meets the tastes of the elderly while respecting their dignity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adapted Garment Prototype, Elderly, Problem Behavior, Dementia, Sphincter Disorders
Keywords
adapted garment prototype, patient dignity, elderly, behavioral troubles, Dementia, sphincter disorders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional garment
Arm Type
Active Comparator
Arm Title
prototype garment
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
garment
Intervention Description
patient randomized in the experimental arm will wear the specially designed garment
Primary Outcome Measure Information:
Title
variation of satisfaction score between both groups of patients
Description
Satisfaction score will be measured with an home-made questionary. Higher scores for highest satisfactory. the questionary is composed of 10 questions.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients hospitalized in a cognitive-behavioral unit or long-term care or residents of the EHPAD at the St-Victor center - CHU Amiens-Picardie,
patients with behavioral and sphincter disorders justifying the prescription of a romper.
signature of a consent exclusion criteria
Exclusion Criteria:
No next of kin
Patients in terminal palliative care
Patients whose morphology does not allow the use of prototypes (no adapted size)
Facility Information:
Facility Name
Centre Hospitalier Universitaire d'Amiens
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Design of a Prototype Garment Adapted to Demented Elderly Subjects With Disturbing Behavioral Problems in the Management of Sphincter Disorders
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